| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anemia (FERWON-IDA) [NCT02940886] | Phase 3 | 1,512 participants (Actual) | Interventional | 2016-11-08 | Completed |
| Is Iron Supplementation Harmful in Populations Where Iron Deficiency is Not the Cause of Anemia? A 12 Week Randomized Controlled Trial in Cambodia [NCT04017598] | Phase 4 | 480 participants (Actual) | Interventional | 2019-12-10 | Active, not recruiting |
| To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy [NCT02441439] | | 0 participants (Actual) | Interventional | 2022-01-01 | Withdrawn(stopped due to The investigators decided not to proceed with this study) |
| Effects of Intravenous Iron Supplementation on Exercise Capacity During Sustained Alveolar Hypoxia in Healthy Humans. [NCT01265108] | Phase 1 | 12 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation [NCT03850652] | | 20 participants (Anticipated) | Interventional | 2019-03-06 | Recruiting |
| Efficacy of Iron Fortified Ultra Rice Compared to Supplemental Iron Drops in Infants and Young Children [NCT00839761] | | 175 participants (Actual) | Interventional | 2006-12-31 | Completed |
| Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-Dialysis Dependent Chronic Kidney Disease (PK-CKD-03) [NCT01213992] | Phase 1 | 16 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Efficacy and Safety of Erythropoietin And/Or Intravenous Iron Sucrose For Treatment of Anemia In Hip and Knee Arthroplasty: A Single-center Retrospective Study [NCT03917394] | | 780 participants (Anticipated) | Observational | 2019-04-24 | Recruiting |
| Trial of Pre-Pregnancy Supplements [NCT01183572] | | 802 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Multicenter, Open-label Active-controlled Randomized Study of Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia) Compared With Maltofer® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewab [NCT03993288] | Phase 3 | 267 participants (Actual) | Interventional | 2019-06-27 | Completed |
| Assessment of Iron Absorption and Requirements During Pregnancy and Lactation in Kenyan Women [NCT05973552] | | 250 participants (Anticipated) | Observational | 2023-07-31 | Recruiting |
| Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators [NCT03651934] | | 600 participants (Anticipated) | Interventional | 2018-10-01 | Not yet recruiting |
| Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions [NCT03944733] | | 0 participants (Actual) | Interventional | 2019-12-01 | Withdrawn(stopped due to The study was never started as a result of change of personnel and funding) |
| A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia [NCT01380548] | | 135 participants (Anticipated) | Interventional | 2011-06-30 | Completed |
| Iron Deficiency Anemia and Infant Behavior: Preventive Trial [NCT01166451] | | 835 participants (Actual) | Interventional | 1991-09-30 | Completed |
| Effectiveness of Adaptation of the Dose of Iron Supplementation in Pregnancy on Maternal-child Health. Randomized Clinical Trial (ECLIPSES) [NCT03196882] | Phase 4 | 704 participants (Actual) | Interventional | 2013-07-10 | Completed |
| Use of Cast Iron Pots to Improve Maternal Anemia [NCT02341300] | | 34 participants (Actual) | Interventional | 2020-07-15 | Terminated(stopped due to Original investigator has left the institution.) |
| A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations [NCT02238704] | | 1,032 participants (Actual) | Interventional | 2014-09-30 | Completed |
| A Randomized Trial to Determine if RBCs From Donors With Iron Deficient Erythropoiesis Have Decreased Post-transfusion RBC Recovery and Whether Iron Repletion Improves Recovery [NCT02889133] | | 85 participants (Actual) | Interventional | 2017-01-31 | Active, not recruiting |
| A Randomized Controlled Pilot Study of Goal-directed Iron Supplementation of Anemic, Critically Ill Trauma Patients With Functional Iron Deficiency, With and Without Oxandrolone [NCT02047552] | Phase 2 | 0 participants (Actual) | Interventional | 2015-01-31 | Withdrawn(stopped due to No Participants enrolled) |
| A Phase III, Randomised, Open-label, Comparative Safety and Efficacy Trial of Intravenous Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Dis [NCT02940860] | Phase 3 | 1,538 participants (Actual) | Interventional | 2016-11-29 | Completed |
| Fermented Iron-rich Supplement in Reducing Anemia [NCT02037724] | Phase 2 | 120 participants (Anticipated) | Interventional | 2014-03-31 | Not yet recruiting |
| Efektifitas Pemberian Zat Besi Dan Vitamin D Terhadap Status Besi Pada Anak Dengan Anemia Defisiensi Besi [NCT06148545] | | 57 participants (Actual) | Interventional | 2023-03-30 | Completed |
| A Study of Efficacy and Safety of Three Different Oral Iron-Containing Dietary Supplements in Correction of Hematological Indices and Replenishment of Depleted Iron Stores in Iron Deficient Adults With or Without Mild Microcytic Anemia [NCT05185024] | | 152 participants (Actual) | Interventional | 2022-01-19 | Active, not recruiting |
| Intravenous Ferric Carboxymaltose Versus Oral Ferrous Sulfate Replacement in Anaemia Due to Acute Nonvariceal Gastrointestinal Bleeding (FIERCE): Protocol of a Multicentre Randomised Controlled Trial [NCT05060731] | Phase 4 | 570 participants (Anticipated) | Interventional | 2024-09-01 | Not yet recruiting |
| A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 (Monofer®) Compared With Iron Sucrose (Venofer®) in Peritoneal Dialysis Patients [NCT03610230] | | 16 participants (Actual) | Interventional | 2019-02-01 | Terminated(stopped due to Difficult patient recruitment due to COVID-19 epidemic) |
| Obesity, Iron Regulation and Colorectal Cancer Risk [NCT03548948] | | 17 participants (Actual) | Interventional | 2015-07-15 | Completed |
| A Repeat Dose, Open Label, Two Period, Randomized, Cross Over Study to Compare the Effect of Daprodustat to Recombinant, Human Erythropoietin (rhEPO) on Oral Iron Absorption in Adult Participants With Anemia Associated With Chronic Kidney Disease Who Are [NCT03457701] | Phase 2 | 15 participants (Actual) | Interventional | 2019-07-30 | Completed |
| The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate [NCT02255942] | | 20 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Outcome of Oral Lactoferrin in Comparison to Amino Acid Chelated Iron and Ferrous Sulphate Supplementation During Pregnancy: A Randomized Control Trial [NCT03542825] | Phase 4 | 300 participants (Actual) | Interventional | 2018-01-01 | Completed |
| [NCT01864161] | Phase 4 | 100 participants (Actual) | Interventional | 2011-10-31 | Completed |
| The Effect of Prebiotics on Iron Absorption in Women With Low Iron Stores: Determination of a Dose-dependent Effect of Galacto-oligosaccharides on Iron Absorption, With and Without Addition of Ascorbic Acid [NCT03762148] | | 46 participants (Actual) | Interventional | 2019-04-01 | Completed |
| Treatment of Iron Defieciency Anemia [NCT02957643] | Phase 1/Phase 2 | 50 participants (Actual) | Interventional | 2016-11-30 | Completed |
| Intravenous Iron Isomaltoside Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy: A Randomized Comparative Trial [NCT05251493] | Phase 3 | 280 participants (Anticipated) | Interventional | 2022-06-06 | Recruiting |
| A Randomized Control Trial of the Lucky Iron Fish to Improve Hemoglobin Concentration in Women in Preah Vihear, Cambodia [NCT02341586] | | 340 participants (Actual) | Interventional | 2015-04-30 | Completed |
| EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations [NCT03382275] | | 51 participants (Actual) | Observational [Patient Registry] | 2018-01-16 | Completed |
| 16 Weeks' Dietary Supplementation With Iron and Iron + Vitamin C on Cerebral Blood Flow and Energy Expenditure in Women of Reproductive Age [NCT04477018] | | 78 participants (Actual) | Interventional | 2017-11-11 | Completed |
| Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children: A Randomized Clinical Trial [NCT00822380] | | 680 participants (Actual) | Interventional | 2003-03-31 | Completed |
| The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles [NCT02175888] | | 20 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Scaling-up High-impact Micronutrient Supplementation Interventions to Improve Adolescents' Nutrition and Health in Burkina Faso [NCT04657640] | Phase 3 | 2,100 participants (Anticipated) | Interventional | 2020-12-11 | Active, not recruiting |
| Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia: A Randomized Controlled [NCT03562143] | | 88 participants (Actual) | Interventional | 2018-08-31 | Completed |
| Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being in Non-anaemic Iron Deficient and Iron Sufficient Women of Reproductive Age [NCT04469010] | | 151 participants (Actual) | Interventional | 2017-06-02 | Completed |
| Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study [NCT04464850] | Phase 3 | 124 participants (Anticipated) | Interventional | 2020-07-29 | Recruiting |
| Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)(PK-CIA-04) [NCT01213979] | Phase 1 | 16 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien) [NCT01216709] | | 72 participants (Actual) | Interventional | 2010-10-31 | Completed |
| Iron Bioavailability From Fortified Cereal in Malawian Infants [NCT03754543] | | 30 participants (Actual) | Interventional | 2019-01-31 | Completed |
| Randomized Open Comparative Trial of Oral Sucrosomial Iron (SiderAl Forte®) and Oral Iron Sulphate (Duroferon®) to Blood Donors. [NCT05678647] | | 120 participants (Anticipated) | Interventional | 2023-01-31 | Recruiting |
| A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis. [NCT00548249] | Phase 2 | 131 participants (Actual) | Interventional | 2007-08-31 | Completed |
| The Effects of a Dietary Iron Program on Iron Status and Cognitive Function Amoung School Children in Phatthalung Province, Southern Thailand [NCT05878379] | | 34 participants (Actual) | Interventional | 2018-05-02 | Completed |
| The Effectiveness of Single Versus Double Daily Dose of Oral Iron on the Prevention of Iron Deficiency Anemia in Obese Pregnant Women [NCT04101461] | | 230 participants (Actual) | Interventional | 2019-10-01 | Completed |
| Treatment of Anemia With Intravenous Iron in Patients Listed for Orthotopic Liver Transplantation [NCT04475887] | Phase 4 | 60 participants (Anticipated) | Interventional | 2020-07-23 | Recruiting |
| Effects of Early Parenteral Iron Combined Erythropoietin in Preterm Infants [NCT02060851] | Phase 4 | 96 participants (Actual) | Interventional | 2014-02-28 | Completed |
| Doubling the Iron Dose VS Single Dose Iron Supplementation to Prevent Iron Deficiency Anemia (IDA) in Twin Pregnant Women: A Randomized Controlled Trial [NCT03836703] | Phase 4 | 450 participants (Actual) | Interventional | 2019-02-01 | Completed |
| Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function [NCT02103205] | | 252 participants (Actual) | Interventional | 2014-06-30 | Active, not recruiting |
| Preoperative, Single-dose Intravenous Iron Formulation to Reduce Post-surgical Complications in Patients Undergoing Major Abdominal Surgery: a Pilot Randomised Control Trial (PIRCAS Trial - Pilot) [NCT03295851] | Phase 4 | 60 participants (Anticipated) | Interventional | 2017-11-22 | Recruiting |
| Comparison of Home Fortification With Two Iron Formulations in Kenyan Children Protected Against Malaria by Artemisinin-based Combination Therapy: a Placebo-controlled Non-inferiority Trial [NCT02073149] | Phase 2/Phase 3 | 338 participants (Actual) | Interventional | 2014-06-30 | Completed |
| A Randomized, Double-blind, Parallel, Three-arms, Placebo-controlled, Safety and Efficacy Study of Botanical Extract Standardized for Iron + Vitamin C and Botanical Extract Standardized for Iron in Adult Human Subjects With Anemia or Iron-deficiency Anemi [NCT06096103] | | 96 participants (Anticipated) | Interventional | 2023-11-15 | Not yet recruiting |
| The Optimization of Bioavailability From Iron Supplements: Examinations of Different Supplementation Regimens Including Hepcidin Profiles [NCT02177851] | | 20 participants (Actual) | Interventional | 2015-06-30 | Completed |
| Phase II Multiple-Dose Treatment of New Onset Type 1 Diabetes Mellitus With Anti-CD3 mAb [NCT00129259] | Phase 2 | 83 participants (Actual) | Interventional | 2005-09-30 | Completed |
| Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas [NCT03897673] | | 600 participants (Anticipated) | Interventional | 2019-09-01 | Enrolling by invitation |
| Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes [NCT04899778] | Phase 4 | 100 participants (Anticipated) | Interventional | 2021-09-29 | Recruiting |
| Physiology Study Investigating the Effects of Supplementation and Depletion of Iron on Hypoxia-related Pulmonary Hypertension [NCT00952302] | | 33 participants (Actual) | Interventional | 2008-10-31 | Completed |
| A Randomized, Open-Label, Single-Dose, Parallel-Design, Bioequivalence Study of Hospira Iron Sucrose Injection Compared to Venofer® Injection USP in Healthy Subjects. [NCT00719459] | Phase 1 | 60 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] Dose Escalation Study for the Treatment of Advanced Solid Tumors: Phase 1 Clinical Trial [NCT06048367] | Phase 1 | 24 participants (Anticipated) | Interventional | 2022-10-14 | Recruiting |
| A Prospective, Randomized, Multi-centered Trial to Compare the Efficacy and Safety of Intravenous Iron Sucrose (Venoferrum®) With Oral Iron Acetyl-transferrin Hydroglycerin (Bolgre®) in Pregnant Women With Iron Deficiency Anemia [NCT00802139] | Phase 4 | 58 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Rationale and Design of Ferric Polymaltose Hydroxide and Iron Sucrose Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study [NCT04225728] | Phase 4 | 45 participants (Actual) | Interventional | 2017-12-01 | Completed |
| Efficacy and Safety of Parenteral Nutrition With Iron Sucrose for Anemia in Preterm Infants: a Randomized, Double-blind Controlled Study [NCT02743572] | | 129 participants (Actual) | Interventional | 2015-09-30 | Completed |
| Maternal Iron Absorption and Utilization and Iron Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infant Iron Status [NCT02747316] | | 83 participants (Actual) | Interventional | 2016-02-29 | Completed |
| The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels [NCT03777904] | | 11 participants (Actual) | Observational | 2019-02-21 | Terminated(stopped due to Analysis of first 11 subjects resulted in values that were too varied to make the study feasible.) |
| Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia [NCT06079918] | Phase 3 | 6,381 participants (Anticipated) | Interventional | 2023-11-30 | Not yet recruiting |
| Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa [NCT02666417] | | 64 participants (Actual) | Interventional | 2016-01-31 | Completed |
| Acceptability and Feasibility of Micronutrient Powders Versus Iron Syrup for Anemia Prevention in Young Children [NCT02610881] | | 110 participants (Actual) | Interventional | 2015-12-31 | Completed |
| Phase IV Randomized Study Evaluating Agents Stimulants Erythropoiesis (ASE) Associated With Ferric Carboxymaltose (Ferinject ®) in Concomitant or Sequential Patients Treated for Cancer and With Anemia Associated With Functional Iron Deficiency [NCT02213653] | Phase 4 | 24 participants (Actual) | Interventional | 2013-04-30 | Terminated |
| Identification of Sentinel Lymph Nodes by Ultrasound Utilizing Iron Tracer Injection and Preoperative Biopsy in Women With Breast Cancer [NCT02610920] | Early Phase 1 | 0 participants (Actual) | Interventional | 2015-12-31 | Withdrawn(stopped due to Unable to enroll subjects) |
| Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion and Improving Outcomes in Patients Undergoing CABG. A Prospective Randomized Trial [NCT04061655] | Early Phase 1 | 80 participants (Actual) | Interventional | 2019-09-20 | Completed |
| Clinical Evaluation of Iron Treatment Efficiency Among Non-anemic But Iron-deficient Female Blood Donors : a Randomized Controlled Trial [NCT00689793] | Phase 4 | 154 participants (Actual) | Interventional | 2008-11-30 | Completed |
| Non-invasive Optical Detection of Iron Deficiency in Children- Evaluation of a Fiber Optic Tissue Fluorescence Measurement to Determine the Erythrocyte Zinc Protoporphyrin-IX/Heme Ratio [NCT02701309] | | 100 participants (Actual) | Observational | 2016-04-30 | Completed |
| Effects of a Commercially-available, Low-dose Iron Supplement (BloodBuilder®/Iron Response®) on Markers of Iron Status Among Premenopausal and Non-anemic, Iron-deficient Women [NCT02683369] | Phase 2/Phase 3 | 23 participants (Actual) | Interventional | 2016-02-29 | Completed |
| An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hype [NCT00841126] | Phase 3 | 657 participants (Anticipated) | Interventional | 2009-07-31 | Terminated |
| Combination With Intravenous Iron Supplementation or Doubling Erythropoietin Dose for Patients With Chemotherapy-induced Anaemia Inadequately Responsive to Initial Erythropoietin Treatment Alone [NCT02731378] | Phase 4 | 603 participants (Anticipated) | Interventional | 2016-12-31 | Not yet recruiting |
| Iron Supplementation to Reduce Preschoolers Anemia: Comparison Between Intermittent and Cyclic Procedure [NCT00992823] | | 99 participants (Actual) | Interventional | 2006-03-31 | Completed |
| Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh [NCT00860470] | Phase 3 | 44,567 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Doseages During Pregnancy in Tanzania [NCT06069869] | Phase 3 | 156 participants (Anticipated) | Interventional | 2025-09-30 | Not yet recruiting |
| Lactoferrin With Iron Versus Iron Alone in Treatment of Anemia In Chronic Liver Disease [NCT04335058] | | 130 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
| Efficacy of Intravenous Ferric Carboxymaltose in the Improvement of Anemia in Patients With Postoperative Knee Prosthesis [NCT01913808] | Phase 4 | 122 participants (Actual) | Interventional | 2011-01-31 | Completed |
| Individually Randomized Trial of Higher-dose Iron (60 mg, 45 mg) Compared to Low-dose Iron (30 mg) in Multiple Micronutrient Supplements in Pregnancy on Moderate and Severe Maternal Anemia- MMS Versus IFA Crossover Trial [NCT06069856] | Phase 3 | 130 participants (Anticipated) | Interventional | 2025-09-30 | Not yet recruiting |
| Study of the Effects of Iron Supplementation on High Altitude Pulmonary Hypertension. [NCT00960921] | Phase 2 | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to Study never started.) |
| A Randomised Controlled Trial Comparing the Efficacy of Intravenous Iron Sucrose and Oral Iron Sulfate in Patients With Iron Deficiency. [NCT01067547] | Phase 4 | 130 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Effects of Taking Prenatal Vitamin-mineral Supplements During Lactation on Iron Status and Markers of Oxidation [NCT01047098] | | 114 participants (Actual) | Interventional | 2008-10-31 | Completed |
| A Clinical Pharmacological Study to Evaluate the Effects of Iron Supplements on the Pharmacokinetics of MT-6548 in Healthy Male Volunteers [NCT03645863] | Phase 3 | 61 participants (Actual) | Interventional | 2018-08-27 | Completed |
| Evaluation of the Effect of Body Weight and Composition on Iron Absorption and Blood Volume [NCT01884506] | | 64 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Phase III Randomized Double Blind Placebo-Controlled Study To Assess The Effects Of FeraMax When Administered Orally Once A Day On Postoperative Fatigue Levels In Patients Following Elective Coronary Artery Bypass Graft Surgery (CABG) [NCT01912261] | Phase 3 | 121 participants (Actual) | Interventional | 2014-12-16 | Terminated(stopped due to The study was stopped due to time constraints and resources) |
| Delivery of Iron and Zinc Supplements: Evaluation of Interaction Effect on Biochemical and Clinical Outcomes [NCT00470158] | Phase 4 | 1,000 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland. [NCT04318405] | | 327 participants (Actual) | Observational | 2020-07-10 | Completed |
| Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods [NCT01991626] | | 47 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Comparison Between Aminoacid Chelated Iron and Iron Salt in Treatment of Iron Deficiency Anemia With Pregnancy [NCT02005588] | Early Phase 1 | 150 participants (Actual) | Interventional | 2013-12-31 | Completed |
| An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis [NCT00824460] | Phase 2 | 154 participants (Actual) | Interventional | 2008-12-31 | Completed |
| Comparative Cross-over Study to Evaluate the Rate and the Extent of Iron Absorption of a New Iron Supplement (With Orodispersible Formulation) vs an Iron Supplement in Capsules, After Administration of a Single Dose in Healthy Volunteers [NCT05660200] | | 9 participants (Actual) | Interventional | 2022-11-25 | Completed |
| Randomized, Parallel Group, Clinical Trial Comparing Intravenous Iron Sucrose Versus Oral Ferrous Sulphate in the Treatment of Perioperative Iron Deficiency in Patients With Colo-Rectal Neoplasm and Iron Deficiency Anemia. [NCT00199277] | Phase 4 | 150 participants | Interventional | | Not yet recruiting |
| [NCT02858505] | Phase 2 | 120 participants (Actual) | Interventional | 2015-08-31 | Completed |
| Evaluation of the Effect of Lactoferrin Versus Intravenous Iron Sucrose in Treatment of Iron Deficiency Anemia During Pregnancy [NCT05921968] | Phase 4 | 100 participants (Anticipated) | Interventional | 2023-07-30 | Not yet recruiting |
| A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study [NCT00593619] | Phase 4 | 200 participants (Anticipated) | Interventional | 2008-01-31 | Suspended(stopped due to Interim Analysis and review by Data Safety Monitoring Board) |
| A Randomized, Open-Label, Wait-list Control Trial To Evaluate the Efficacy of Intravenous Iron in Older Adults With Unexplained Anemia and a Serum Ferritin Between 20 and 200 ng/mL [NCT01309659] | Phase 2 | 19 participants (Actual) | Interventional | 2011-05-31 | Terminated(stopped due to Lack of Enrollment) |
| Effects of Intermittent Iron and Vitamin A Supplementation on Nutritional Status and Development of Schoolchildren in Arba Minch Zuria District, Ethiopia. [NCT04137354] | | 504 participants (Actual) | Interventional | 2020-11-02 | Completed |
| Teff (Eragrostis Tef) as a Functional Food for the Prevention of Pregnancy Iron-deficiency Anemia [NCT01055431] | Phase 1 | 55 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Comparison of Iron Absorption From Extruded FePP-fortified Rice Containing Different Zinc Compounds, Citric Acid/Trisodium Citrate and Sodium EDTA [NCT02714075] | | 30 participants (Actual) | Interventional | 2016-04-30 | Completed |
| Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants [NCT01125163] | | 150 participants (Actual) | Interventional | 2010-05-31 | Completed |
| Randomized Controlled Trial of Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative Colitis [NCT05225545] | Phase 3 | 30 participants (Anticipated) | Interventional | 2019-11-04 | Recruiting |
| Timing, Duration and Severity of Infant Iron Deficiency: Developmental Impacts [NCT00613717] | | 2,371 participants (Actual) | Interventional | 2009-11-30 | Completed |
| The Role of Sub-clinical Inflammation on the Iron Status of Myanmar Anaemic Adolescent Schoolgirls During Iron and Vitamin A Supplementation [NCT01198574] | Phase 3 | 402 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia [NCT00236977] | Phase 3 | 182 participants (Actual) | Interventional | 2003-08-31 | Completed |
| Iron-Deficiency Anemia in Infants: Comparative Study of Two Weekly Supplement Programs [NCT00655408] | | 130 participants (Actual) | Interventional | 2003-04-30 | Completed |
| Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial [NCT00895453] | | 144 participants (Actual) | Interventional | 2000-05-31 | Completed |
| Impact of Vitamin B12 Supplementation With Iron and Folic Acid on Adolescent Girls [NCT01490944] | Phase 2 | 360 participants (Anticipated) | Interventional | 2012-01-31 | Recruiting |
| Randomized Trial Comparing Intravenous Iron Carboxymaltose, Intravenous Iron Isomaltoside and Oral Iron Sulphate for Postpartum Anemia [NCT03957057] | Phase 3 | 300 participants (Actual) | Interventional | 2020-09-10 | Completed |
| Swiss Functional Iron Deficiency Study [NCT00495781] | | 77 participants (Actual) | Interventional | 2004-10-31 | Completed |
| Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women [NCT02815449] | | 24 participants (Actual) | Interventional | 2017-05-08 | Completed |
| Iron Metabolism in Small Pre Term Newborns [NCT01443195] | | 50 participants (Anticipated) | Interventional | 2011-10-31 | Active, not recruiting |
| Iron Supplementation for Acute Anemia After Postbariatric Abdominoplasty: a Randomized Controlled Trial [NCT01857011] | Phase 3 | 56 participants (Actual) | Interventional | 2014-04-30 | Completed |
| A Pilot Study Comparing Tolerance of Oral Heme Iron Polypeptide With Oral Ionic Iron [NCT01865175] | Phase 4 | 0 participants (Actual) | Interventional | 2016-01-31 | Withdrawn(stopped due to Institution required IND, although FDA did not, so institution did not allow enrollment) |
| A Phase 2, Randomized, Open-Label, Dose Titration, Safety and Efficacy Study of FG-4592 for the Correction of Anemia in Newly Initiated Dialysis Patients Not on Erythropoiesis-Stimulating Agent Treatment [NCT01414075] | Phase 2 | 60 participants (Actual) | Interventional | 2011-07-21 | Completed |
| Amino Acid Chelated Iron Versus Ferrous Fumarate in the Treatment of Iron Deficiency Anemia With Pregnancy: Randomized Controlled Trial [NCT03830034] | Phase 4 | 150 participants (Anticipated) | Interventional | 2019-02-02 | Recruiting |
| Evaluation of Iron Absorption From Ferric Ammonium Phosphate and Ferric Pyrophosphate From an Instant Milk Drink in Young Children [NCT05642689] | | 40 participants (Actual) | Interventional | 2009-11-30 | Completed |
| Sucrosomial Iron Supplementation in Anaemic Patients With Celiac Disease Not Tolerating Oral Ferrous Sulfate [NCT02916654] | | 20 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients [NCT02972294] | Phase 3 | 419 participants (Actual) | Interventional | 2017-03-31 | Terminated(stopped due to 1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=>stop inclusions) |
| Effects of Oral Iron Supplementation Before vs. at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women [NCT05919472] | | 180 participants (Anticipated) | Interventional | 2023-07-01 | Recruiting |
| Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months [NCT00269542] | | 94,359 participants (Actual) | Interventional | 2002-02-28 | Completed |
| Meals to Improve Absorption of Iron Supplements and Iron Status in Iron Deficient Women of Reproductive Age: a Randomized, Controlled Trial [NCT04793906] | | 80 participants (Anticipated) | Interventional | 2021-05-10 | Recruiting |
| A Single-center, Double-blinded, Randomized, 12 Week, Superiority Study in Infants and Young Children to Compare the Efficacy of NovaFerrum® Versus Ferrous Sulfate in the Treatment of Nutritional Iron Deficiency Anemia. [NCT01904864] | Phase 4 | 80 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Assessment of Complementary Feeding of Canadian Infants [NCT01790542] | | 87 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Randomized Controlled Study of Iron Supplementation to Support the Response to Recombinant Human Erythropoietin for the Treatment of Chemotherapy-Induced Anaemia [NCT00482716] | Phase 3 | 80 participants (Anticipated) | Interventional | 2007-01-31 | Active, not recruiting |
| Double-blind Comparator of Efficacy of Oral (Ferrous Sulfate) vs. Intravenous Iron (Ferumoxytol) for Treatment of the Restless Legs Syndrome (RLS) Occurring With Iron Deficient Anemia (IDA) [NCT02499354] | Phase 2 | 100 participants (Actual) | Interventional | 2014-08-31 | Completed |
| Evaluation of the Validity of a Novel Isotope Dilution Method to Assess the Iron Status and Its Changes in Swiss Women [NCT02979132] | | 60 participants (Anticipated) | Interventional | 2017-09-01 | Active, not recruiting |
| An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 Compared With Sevelamer Carbonate Followed by a Randomised Comparison of PA21 Maintenance Dose Versus PA21-Low Dose in [NCT01324128] | Phase 3 | 1,059 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Iron Sucrose Combined With rHuEPO and Ascorbic Acid on Perioperative Allogeneic Red Blood Cell Infusion in Patients Undergoing Elective Major Cardiac Surgery [NCT05353348] | | 370 participants (Anticipated) | Interventional | 2023-02-15 | Recruiting |
| Effects of a Dietary Approach to Iron Deficiency in Premenopausal Women Affected by Celiac Disease [NCT02949765] | | 35 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting |
| Safe and Effective Delivery of Supplemental Iron to Healthy Volunteers [NCT03212677] | | 224 participants (Anticipated) | Interventional | 2017-05-17 | Recruiting |
| Study to Measure the Absorption of Iron From Ferrous Gluconate Incorporated Into Alginate Beads. [NCT01528644] | | 16 participants (Actual) | Interventional | 2012-02-29 | Completed |
| The Value of Iron Treatment for Postoperative Obstetric Patients With Anemia: a Randomized Double Blind Controlled Trial [NCT01975272] | Phase 4 | 27 participants (Actual) | Interventional | 2015-03-02 | Terminated(stopped due to Disapointing randomization rate) |
| A Randomized, Controlled, Double Blinded Clinical Trial of Intravenous Iron Sucrose in Adolescents With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS) [NCT01978535] | Phase 1/Phase 2 | 3 participants (Actual) | Interventional | 2014-12-17 | Terminated(stopped due to Difficulty in recruiting subjects.) |
| Testing Iron Absorption From a New Micronutrient Powder Containing Galacto-oligosaccharides (GOS) for Fortification of Infant Foods in Sub-Saharan Africa [NCT02989311] | | 23 participants (Actual) | Interventional | 2016-08-31 | Completed |
| Monocentric, Prospective, Randomized Study to Evaluate the Efficacy of a New Iron Supplement With Orodispersible Formulation vs an Iron Supplement in Capsules in Subjects With Mild Anemia [NCT05989984] | | 60 participants (Anticipated) | Interventional | 2023-08-04 | Recruiting |
| A Phase III, Randomized, Parallel Group, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of PGL4001 (Ulipristal) Versus Placebo for Pre-Operative Treatment of Symptomatic Uterine Myomas [NCT00755755] | Phase 3 | 241 participants (Actual) | Interventional | 2008-10-31 | Completed |
| ANEMEX UK Trial: Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial [NCT03214627] | | 88 participants (Actual) | Interventional | 2018-12-10 | Terminated(stopped due to Standard clinical practice at site caused unforeseen issues for the use of the ACM) |
| Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Moderate to Severe Iron Deficient Anemia of Pregnancy in Women Intolerant of or Responsive to Oral Iron. [NCT02038023] | Phase 2 | 74 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Prevention of Iron Deficiency Anemia Post-delivery (PRIORITY Trial): A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research [NCT05590260] | Phase 3 | 4,800 participants (Anticipated) | Interventional | 2023-05-30 | Recruiting |
| Comparison of the Safety and Efficacy of Three Iron Sucrose Maintenance Regimens in Pediatric Chronic Kidney Disease (CKD) Patients [NCT00239642] | Phase 4 | 141 participants (Actual) | Interventional | 2005-07-31 | Completed |
| Comparison of Iron Absorption From Regular-iron, Iron Biofortified, and Post-harvest Iron-fortified Pearl Millet Using Multiple Meals in Young Women [NCT01634932] | | 22 participants (Actual) | Interventional | 2012-07-31 | Completed |
| [NCT01733979] | | 80 participants (Actual) | Interventional | 2012-02-07 | Completed |
| Acute vs. Delayed Iron: Effect on Red Cell Iron Incorporation in Severe Malaria [NCT01754701] | | 100 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Chelated Oral Iron Versus Intravenous Iron Sucrose for Treatment of Iron Deficiency Anemia Late in Pregnancy ( Randomized Controlled Trial ) [NCT05151679] | | 0 participants | Expanded Access | | Available |
| Is Iron Deficiency the Cause of Anemia Among Women of Reproductive Age in Cambodia? A 2 x 2 Factorial Double Blind Randomized Controlled Trial of Oral Iron and Multiple Micronutrient Supplementation [NCT02481375] | | 809 participants (Actual) | Interventional | 2015-07-31 | Completed |
| Defining the Functional and Metabolic Role of Iron in Aerobic Training and Physical Performance [NCT03002090] | | 109 participants (Actual) | Interventional | 2014-08-31 | Completed |
| Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease [NCT02151643] | Phase 2 | 153 participants (Actual) | Interventional | 2014-05-07 | Completed |
| A Randomised Phase II Trial of Iron Isomaltide Versus Oral Iron Supplement for Radiotherapy or Chemotherapy Associated Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma [NCT05913414] | Phase 2 | 120 participants (Anticipated) | Interventional | 2023-05-05 | Recruiting |
| Role of Iron, Alpha-Synuclein, and Lymphocyte-activation Gene-3 in the Pathophysiology of Ischemic Stroke in Human and Albino Rats [NCT05748587] | | 48 participants (Anticipated) | Observational | 2023-04-01 | Recruiting |
| A Comparison Between Intravenous Iron Sucrose to Its Combination With Oral Iron Supplements for the Treatment of Postpartum Anemia [NCT02458625] | | 158 participants (Actual) | Interventional | 2016-04-30 | Completed |
| Zinc, Iron and Vitamin A Supplementation for Infant Growth and Development, and the Contributing Role of Psychosocial Care [NCT02319499] | Phase 3 | 800 participants (Actual) | Interventional | 1998-08-31 | Completed |
| Erythropoietin to Prevent Unnecessary Transfusions In Patients With Cyanotic Congenital Heart Disease - A Prospective Randomized Control Trial [NCT02564796] | Phase 2 | 4 participants (Actual) | Interventional | 2016-11-30 | Terminated(stopped due to COVID) |
| Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City [NCT05311436] | | 3,260 participants (Anticipated) | Interventional | 2022-07-01 | Recruiting |
| Efficacy and Safety of Perioperative Iron Supplementation for Postoperative Rehabilitation of Geriatric Hip Fractures: a Multicenter, Randomized, Controlled Trial. [NCT05489952] | Phase 4 | 444 participants (Anticipated) | Interventional | 2022-09-15 | Recruiting |
| A Randomised, Double-blinded, Parallel Group Study to Demonstrate the Adherence and Efficacy of Different Doses of Iron Supplement in Subjects With or At-risk of Iron Deficiency With a History of Intolerance to Oral Iron [NCT04778072] | | 60 participants (Anticipated) | Interventional | 2018-10-08 | Active, not recruiting |
| Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease [NCT05456932] | Phase 4 | 90 participants (Anticipated) | Interventional | 2022-08-19 | Recruiting |
| Prospective Study of Iron Deficiency Anemia in Twin Pregnancy [NCT04975074] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2021-07-15 | Not yet recruiting |
| Randomized, Double-blind, Community-based Efficacy Trial of Various Doses of Zinc in Micronutrient Powders or Tablets in Young, Bangladeshi Children [NCT03406793] | | 2,886 participants (Actual) | Interventional | 2018-02-20 | Completed |
| Interactions of Lead Intoxication and Iron Deficiency in Morocco: The Effects of Iron Fortification With and Without NaEDTA on Lead Burden, Iron Status and Cognition in Children [NCT01573013] | | 457 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Trial of Darbepoetin Plus Slow-release Intravenous Iron to Decrease Transfusions and Improve Iron Status and Neurodevelopment in Preterm Infants [NCT05340465] | Phase 2 | 120 participants (Anticipated) | Interventional | 2022-11-27 | Recruiting |
| A Phase III, Randomized, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemother [NCT01145638] | Phase 3 | 350 participants (Actual) | Interventional | 2010-10-31 | Completed |
| The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease [NCT00384657] | Phase 3 | 0 participants (Actual) | Interventional | 2008-01-31 | Withdrawn(stopped due to Lack of cooperation among centers, Financial reasons) |
| FLIPS: Ferfer Liposomal Iron Performance Study [NCT03112187] | Phase 4 | 400 participants (Actual) | Interventional | 2017-08-01 | Completed |
| A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE [NCT02130063] | Phase 3 | 511 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Iron Bioavailability From Fortified Food in Healthy Women [NCT02993835] | | 23 participants (Actual) | Interventional | 2016-12-31 | Completed |
| Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study [NCT00318812] | Phase 2/Phase 3 | 55 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Iron Sucrose In The Treatment of Restless Legs Syndrome (RLS): The Safety of Three Dose Regimens as Evaluated by Clinical Assessments [NCT00895232] | Phase 2 | 21 participants (Actual) | Interventional | 2003-11-30 | Completed |
| Enteral Iron Supplementation and Intestinal Health in Preterm Infants [NCT04497012] | Phase 4 | 183 participants (Anticipated) | Interventional | 2020-11-17 | Recruiting |
| Daily vs. Every Other Day Oral Iron Supplementation in Patients With Absolute Iron Deficiency Anemia (DEODO): a Multi-centered, Pilot Randomized Controlled Trial [NCT03725384] | Phase 3 | 52 participants (Actual) | Interventional | 2019-01-04 | Completed |
| Effectiveness of Quadruple Fortified Salt in Improving Hemoglobin Levels Among Anemic Women of Reproductive Age (18-49 Years) in Rural Low Resource Setting [NCT04404751] | | 174 participants (Actual) | Interventional | 2019-08-23 | Completed |
| Clinical Observation of The Gynecological Iron-Deficiency Anemia Treated With Buxue Yimu Pills [NCT03232554] | Phase 2 | 180 participants (Anticipated) | Interventional | 2017-06-01 | Recruiting |
| Oral Iron Repletion Effects On Oxygen Uptake in Heart Failure [NCT02188784] | Phase 3 | 225 participants (Actual) | Interventional | 2014-09-03 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00129259 (3) [back to overview] | Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT) |
| NCT00129259 (3) [back to overview] | Change in HbA1c |
| NCT00129259 (3) [back to overview] | Change in Average Total Insulin Dose Per Body Weight |
| NCT00236977 (7) [back to overview] | Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 |
| NCT00236977 (7) [back to overview] | Patients With an Increase in Hemoglobin >= 1gm/dL. |
| NCT00236977 (7) [back to overview] | Number of Subjects With a Clinical Response |
| NCT00236977 (7) [back to overview] | Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 |
| NCT00236977 (7) [back to overview] | Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 |
| NCT00236977 (7) [back to overview] | Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 |
| NCT00236977 (7) [back to overview] | Mean Change in Ferritin (ng/mL) From Baseline to Day 56 |
| NCT00239642 (9) [back to overview] | Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline |
| NCT00239642 (9) [back to overview] | Number of Subjects Achieving Clinical Success |
| NCT00239642 (9) [back to overview] | Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive |
| NCT00239642 (9) [back to overview] | Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event |
| NCT00239642 (9) [back to overview] | Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive |
| NCT00239642 (9) [back to overview] | Percentage (%) of Subjects Achieving Clinical Success |
| NCT00239642 (9) [back to overview] | Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive |
| NCT00239642 (9) [back to overview] | Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline |
| NCT00239642 (9) [back to overview] | Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive |
| NCT00318812 (3) [back to overview] | Hemoglobin Concentration at 6 Months |
| NCT00318812 (3) [back to overview] | Ferritin |
| NCT00318812 (3) [back to overview] | Transferrin Saturation |
| NCT00470158 (1) [back to overview] | Incidence of Diarrhea |
| NCT00548249 (6) [back to overview] | Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group. |
| NCT00548249 (6) [back to overview] | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. |
| NCT00548249 (6) [back to overview] | Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements. |
| NCT00548249 (6) [back to overview] | Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. |
| NCT00548249 (6) [back to overview] | Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. |
| NCT00548249 (6) [back to overview] | Change From Baseline in Hemoglobin (Hgb) |
| NCT00689793 (6) [back to overview] | Ferritin Change Before and After 4 Weeks of Treatment/Placebo |
| NCT00689793 (6) [back to overview] | Adherence to Treatment. |
| NCT00689793 (6) [back to overview] | Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test |
| NCT00689793 (6) [back to overview] | Hemoglobin Variation Before and After Treatment vs Placebo |
| NCT00689793 (6) [back to overview] | Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale. |
| NCT00689793 (6) [back to overview] | Response of Iron Supplementation on Mental Disorder |
| NCT00755755 (2) [back to overview] | Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) |
| NCT00755755 (2) [back to overview] | Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) |
| NCT00824460 (4) [back to overview] | Change From Baseline in Serum-phosphate Levels at Week 4 |
| NCT00824460 (4) [back to overview] | Change From Baseline in Serum-phosphate Levels at Week 2 |
| NCT00824460 (4) [back to overview] | Change From Baseline in Serum-phosphate Levels at the End of Treatment. |
| NCT00824460 (4) [back to overview] | Change From Baseline in Serum-phosphate Levels at Week 5 |
| NCT00860470 (10) [back to overview] | Still Birth Rates |
| NCT00860470 (10) [back to overview] | Very Pre-term |
| NCT00860470 (10) [back to overview] | Moderate to Late Preterm |
| NCT00860470 (10) [back to overview] | Preterm Birth |
| NCT00860470 (10) [back to overview] | Low Birth Weight |
| NCT00860470 (10) [back to overview] | Extremely Pre-term |
| NCT00860470 (10) [back to overview] | Infant Mortality Through 6 mo of Age |
| NCT00860470 (10) [back to overview] | Small for Gestation Age |
| NCT00860470 (10) [back to overview] | Neonatal Mortality |
| NCT00860470 (10) [back to overview] | Post-neonatal Mortality |
| NCT00895232 (3) [back to overview] | Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale |
| NCT00895232 (3) [back to overview] | Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's) |
| NCT00895232 (3) [back to overview] | Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner. |
| NCT00895453 (1) [back to overview] | Candida Culture Free After Maintenance Therapy |
| NCT01125163 (2) [back to overview] | Number of Participants Who Received Red Cell Transfusions During Intervention Period |
| NCT01125163 (2) [back to overview] | Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA) |
| NCT01145638 (2) [back to overview] | Change in Hemoglobin From Baseline to Week 24 |
| NCT01145638 (2) [back to overview] | Change in Hb Concentration |
| NCT01198574 (3) [back to overview] | Haemoglobin Level |
| NCT01198574 (3) [back to overview] | Status of Tissue Iron Store |
| NCT01198574 (3) [back to overview] | Status of Cellular Iron Deficiency |
| NCT01309659 (18) [back to overview] | Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory |
| NCT01309659 (18) [back to overview] | Change in Cognitive Outcome Measures as Determined by Speed of Processing |
| NCT01309659 (18) [back to overview] | Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B |
| NCT01309659 (18) [back to overview] | Change in Frailty Component as Determined by Grip Strength |
| NCT01309659 (18) [back to overview] | Change in Frailty Component as Determined by the 4 Meter Walk Speed |
| NCT01309659 (18) [back to overview] | Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score |
| NCT01309659 (18) [back to overview] | Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS) |
| NCT01309659 (18) [back to overview] | Change in the Frailty Component as Determined by Self-reported Activity Level |
| NCT01309659 (18) [back to overview] | Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks |
| NCT01309659 (18) [back to overview] | Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance |
| NCT01309659 (18) [back to overview] | Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance |
| NCT01309659 (18) [back to overview] | Number of Participants Who Had a Hemoglobin Increase >= 1g/dL |
| NCT01309659 (18) [back to overview] | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance |
| NCT01309659 (18) [back to overview] | Change in Frailty Component Related to Fatigue/ Exhaustion |
| NCT01309659 (18) [back to overview] | Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB) |
| NCT01309659 (18) [back to overview] | Change in 6 Minute Walk Test Results |
| NCT01309659 (18) [back to overview] | Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing |
| NCT01309659 (18) [back to overview] | Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin |
| NCT01324128 (2) [back to overview] | Change in Serum Phosphorus Levels From Baseline to Week 12 |
| NCT01324128 (2) [back to overview] | Change in Serum Phosphorus Levels From Week 24 to Week 27 |
| NCT01414075 (27) [back to overview] | Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13 |
| NCT01414075 (27) [back to overview] | Median Time to Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) |
| NCT01414075 (27) [back to overview] | Number of Participants Requiring Therapeutic Phlebotomy |
| NCT01414075 (27) [back to overview] | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL |
| NCT01414075 (27) [back to overview] | Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL |
| NCT01414075 (27) [back to overview] | Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL |
| NCT01414075 (27) [back to overview] | Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL |
| NCT01414075 (27) [back to overview] | Number of Participants With TEAEs |
| NCT01414075 (27) [back to overview] | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy |
| NCT01414075 (27) [back to overview] | Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline) |
| NCT01414075 (27) [back to overview] | Change From Baseline in Ferritin at Week 13 |
| NCT01414075 (27) [back to overview] | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 |
| NCT01414075 (27) [back to overview] | Change From Baseline in Reticulocyte Hemoglobin Content at Week 13 |
| NCT01414075 (27) [back to overview] | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 |
| NCT01414075 (27) [back to overview] | Change From Baseline in Transferrin Saturation (TSAT) at Week 13 |
| NCT01414075 (27) [back to overview] | Maximum Change From Baseline in Hb During Weeks 3-13 |
| NCT01414075 (27) [back to overview] | Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13 |
| NCT01414075 (27) [back to overview] | Number of Participants Requiring Dose Increase at Weeks 5 and 9 |
| NCT01414075 (27) [back to overview] | Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis |
| NCT01414075 (27) [back to overview] | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) |
| NCT01414075 (27) [back to overview] | Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C) |
| NCT01414075 (27) [back to overview] | Number of Participants Who Achieved Maximum Hb During Weeks 3-13 |
| NCT01414075 (27) [back to overview] | Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13 |
| NCT01414075 (27) [back to overview] | Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13 |
| NCT01414075 (27) [back to overview] | Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13 |
| NCT01414075 (27) [back to overview] | Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13 |
| NCT01414075 (27) [back to overview] | Number of Participants With Potentially Clinically Significant Laboratory Tests |
| NCT01904864 (1) [back to overview] | Hemoglobin Concentration Over Time |
| NCT01975272 (3) [back to overview] | Serum Ferritin |
| NCT01975272 (3) [back to overview] | Serum Hepcidin |
| NCT01975272 (3) [back to overview] | Hemoglobin |
| NCT02038023 (4) [back to overview] | Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). |
| NCT02038023 (4) [back to overview] | Serum Ferritin |
| NCT02038023 (4) [back to overview] | Safety as Measured by Number of Adverse Events |
| NCT02038023 (4) [back to overview] | Percent Transferrin Saturation |
| NCT02130063 (4) [back to overview] | Change in Transferrin Saturation (TSAT) |
| NCT02130063 (4) [back to overview] | Change in Hb Concentration |
| NCT02130063 (4) [back to overview] | Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5 |
| NCT02130063 (4) [back to overview] | Change in Serum (s)-Ferritin Concentration |
| NCT02151643 (6) [back to overview] | Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
| NCT02151643 (6) [back to overview] | Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
| NCT02151643 (6) [back to overview] | Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
| NCT02151643 (6) [back to overview] | Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
| NCT02151643 (6) [back to overview] | Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
| NCT02151643 (6) [back to overview] | Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29) |
| NCT02188784 (6) [back to overview] | Change in Plasma NT-pro BNP |
| NCT02188784 (6) [back to overview] | Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption) |
| NCT02188784 (6) [back to overview] | Change From Baseline in Ventilatory Efficiency Defined by Ve/VCO2 |
| NCT02188784 (6) [back to overview] | Change From Baseline in O2 Uptake Kinetics as Assessed by Mean Response Time From CPET |
| NCT02188784 (6) [back to overview] | Change in Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical Summary Score |
| NCT02188784 (6) [back to overview] | Change From Baseline in Sub-maximal Exercise Capacity as Assessed by the 6 Minute Walk Test (6MWT) |
| NCT02481375 (1) [back to overview] | Hemoglobin Levels at 12-weeks. Marginal Means (95% CI). |
| NCT02499354 (3) [back to overview] | Percentage of Participants With Improvement on Clinical Global Impression Scale |
| NCT02499354 (3) [back to overview] | Number of Participants With Adverse Events Judged Related or Possibly Related to Treatment. |
| NCT02499354 (3) [back to overview] | Change From Baseline in the Restless Legs Syndrome Rating Scale |
| NCT02940860 (20) [back to overview] | Composite Cardiovascular Adverse Events (AEs) |
| NCT02940860 (20) [back to overview] | S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 |
| NCT02940860 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car |
| NCT02940860 (20) [back to overview] | Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions |
| NCT02940860 (20) [back to overview] | Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 |
| NCT02940860 (20) [back to overview] | Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 |
| NCT02940860 (20) [back to overview] | Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8 |
| NCT02940860 (20) [back to overview] | Change in Hemoglobin (Hb) From Baseline to Week 8 |
| NCT02940860 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit |
| NCT02940860 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits |
| NCT02940860 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking |
| NCT02940860 (20) [back to overview] | Health Care Resource Use Questionnaire |
| NCT02940860 (20) [back to overview] | Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8 |
| NCT02940860 (20) [back to overview] | Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8 |
| NCT02940860 (20) [back to overview] | Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8 |
| NCT02940860 (20) [back to overview] | Change in Hb Concentration From Baseline to Week 1, 2, and 4 |
| NCT02940860 (20) [back to overview] | Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8 |
| NCT02940860 (20) [back to overview] | Time to First Composite Cardiovascular Safety AE |
| NCT02940860 (20) [back to overview] | Time to Change in Hb Concentration ≥1 g/dL |
| NCT02940860 (20) [back to overview] | S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 |
| NCT02940886 (20) [back to overview] | Composite Cardiovascular Adverse Events (AEs) |
| NCT02940886 (20) [back to overview] | Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 |
| NCT02940886 (20) [back to overview] | Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 |
| NCT02940886 (20) [back to overview] | Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions |
| NCT02940886 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car |
| NCT02940886 (20) [back to overview] | S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 |
| NCT02940886 (20) [back to overview] | S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 |
| NCT02940886 (20) [back to overview] | Time to Change in Hb Concentration ≥2 g/dL |
| NCT02940886 (20) [back to overview] | Time to First Composite Cardiovascular Safety AE |
| NCT02940886 (20) [back to overview] | Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8 |
| NCT02940886 (20) [back to overview] | Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8 |
| NCT02940886 (20) [back to overview] | Change in Hb Concentration From Baseline to Week 1, 2, and 4 |
| NCT02940886 (20) [back to overview] | Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8 |
| NCT02940886 (20) [back to overview] | Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8 |
| NCT02940886 (20) [back to overview] | Health Care Resource Use Questionnaire |
| NCT02940886 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking |
| NCT02940886 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits |
| NCT02940886 (20) [back to overview] | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit |
| NCT02940886 (20) [back to overview] | Change in Hemoglobin (Hb) From Baseline to Week 8 |
| NCT02940886 (20) [back to overview] | Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8 |
| NCT03457701 (14) [back to overview] | Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO |
| NCT03457701 (14) [back to overview] | Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO |
| NCT03645863 (21) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Maximum Plasma Concentration (Cmax) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Terminal Elimination Half-life (t1/2) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Terminal Elimination Half-life (t1/2) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Terminal Elimination Half-life (t1/2) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Maximum Plasma Concentration (Cmax) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Maximum Plasma Concentration (Cmax) of Unchanged MT-6548 |
| NCT03645863 (21) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548 |
| NCT03993288 (6) [back to overview] | Change From Baseline in Percent Transferrin Saturation |
| NCT03993288 (6) [back to overview] | Change From Baseline in Ferritin |
| NCT03993288 (6) [back to overview] | Change From Baseline in Transferrin |
| NCT03993288 (6) [back to overview] | Number of Participants With Response to the Therapy |
| NCT03993288 (6) [back to overview] | Change From Baseline in Blood Hemoglobin Level (g/L) |
| NCT03993288 (6) [back to overview] | Change From Baseline in Serum Iron |
Change in Mean C-peptide Area Under the Curve (AUC) Response to a Mixed Meal Tolerance Test (MMTT)
C-peptide AUC is computed using the trapezoidal rule and dividing by the interval of time from the 4 hour Mixed Meal Tolerance Test (MMTT) where assessments are taken every 30 minutes after initial assessments 15 minutes apart. A higher C-peptide AUC is desirable as detectable C-peptide is a marker for the ability of the pancreas to produce insulin in response to a MMTT. The baseline data was used to adjust for the C-peptide AUC primary endpoint at 24 months. Missing month 24 C-peptide results are imputed using a conservative scenario. (NCT00129259)
Timeframe: Baseline (Pre-treatment), Month 24
| Intervention | pmol/mL (Least Squares Mean) |
|---|
| Anti-CD3 mAb Plus Diabetes Standard of Care Treatment | -0.28 |
| Diabetes Standard of Care Treatment | -0.46 |
Change in HbA1c
Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time and measures the level of optimal management of underlying disease. (Normal :< 5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher).A decline in HbA1c from baseline to month 24 signifies an improvement in diabetic control. The goal of treatment: to maintain the HgA1c level as close to normal as possible without frequent occurrence of hypoglycemia. (NCT00129259)
Timeframe: Baseline (Pre-treatment), Month 24
| Intervention | Percentage (%) (Mean) |
|---|
| Anti-CD3 mAb Plus Diabetes Standard of Care Treatment | 0.129 |
| Diabetes Standard of Care Treatment | 0.195 |
Change in Average Total Insulin Dose Per Body Weight
This measure is computed using the average amount of exogenous insulin taken per day for the 3 days prior to the visit. The average insulin use is divided by the subject's weight in kilograms (kg). The need for lower dose(s) of prescribed exogenous insulin while maintaining optimal control of a subject's diabetes reflects improved management of the underlying disease. (NCT00129259)
Timeframe: Baseline (Pre-treatment), Month 24
| Intervention | Units of Insulin/kilogram/day (U/kg/day) (Mean) |
|---|
| Anti-CD3 mAb Plus Diabetes Standard of Care Treatment | 0.23 |
| Diabetes Standard of Care Treatment | 0.35 |
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
(NCT00236977)
Timeframe: Change from Baseline at Day 56
| Intervention | g/dL (Mean) |
|---|
| Venofer | .7 |
| Ferrous Sulfate | .3 |
Patients With an Increase in Hemoglobin >= 1gm/dL.
(NCT00236977)
Timeframe: Change from Baseline up to Day 56
| Intervention | participants (Number) |
|---|
| Venofer | 35 |
| Ferrous Sulfate | 23 |
Number of Subjects With a Clinical Response
Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml) (NCT00236977)
Timeframe: Change from Baseline up to Day 56
| Intervention | participants (Number) |
|---|
| Venofer | 31 |
| Ferrous Sulfate | 1 |
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
(NCT00236977)
Timeframe: Change from Baseline up to Day 56
| Intervention | ng/mL (Mean) |
|---|
| Venofer | 391.7 |
| Ferrous Sulfate | 45 |
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
(NCT00236977)
Timeframe: Change from Baseline up to Day 56
| Intervention | g/dL (Mean) |
|---|
| Venofer | 1.1 |
| Ferrous Sulfate | .8 |
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
(NCT00236977)
Timeframe: Change from Baseline at Day 56
| Intervention | percentage of change (Mean) |
|---|
| Venofer | 8.5 |
| Ferrous Sulfate | 5.5 |
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
(NCT00236977)
Timeframe: Change from Baseline at Day 56
| Intervention | ng/mL (Mean) |
|---|
| Venofer | 230 |
| Ferrous Sulfate | 30 |
Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline
Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period
| Intervention | participants (Number) |
|---|
| Venofer (0.5 mg/kg) | 46 |
| Venofer (1.0 mg/kg) | 45 |
| Venofer (2.0 mg/kg) | 39 |
Number of Subjects Achieving Clinical Success
Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose) (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period
| Intervention | participants (Number) |
|---|
| Venofer (0.5 mg/kg) | 44 |
| Venofer (1.0 mg/kg) | 40 |
| Venofer (2.0 mg/kg) | 33 |
Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive (NCT00239642)
Timeframe: anytime during the 12-week post-baseline period
| Intervention | participants (Number) |
|---|
| Venofer (0.5 mg/kg) | 46 |
| Venofer (1.0 mg/kg) | 43 |
| Venofer (2.0 mg/kg) | 38 |
Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event
Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm (NCT00239642)
Timeframe: baseline through week 12
| Intervention | participants (Number) |
|---|
| Venofer (0.5 mg/kg) | 27 |
| Venofer (1.0 mg/kg) | 25 |
| Venofer (2.0 mg/kg) | 26 |
Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive
Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period
| Intervention | participants (Number) |
|---|
| Venofer (0.5 mg/kg) | 44 |
| Venofer (1.0 mg/kg) | 42 |
| Venofer (2.0 mg/kg) | 37 |
Percentage (%) of Subjects Achieving Clinical Success
Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose) (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period
| Intervention | percentage of subjects (Number) |
|---|
| Venofer (0.5 mg/kg) | 95.7 |
| Venofer (1.0 mg/kg) | 88.9 |
| Venofer (2.0 mg/kg) | 82.5 |
Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive
Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period
| Intervention | percentage of subjects (Number) |
|---|
| Venofer (0.5 mg/kg) | 95.7 |
| Venofer (1.0 mg/kg) | 93.3 |
| Venofer (2.0 mg/kg) | 92.5 |
Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline
Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period
| Intervention | percentage of subjects (Number) |
|---|
| Venofer (0.5 mg/kg) | 100.0 |
| Venofer (1.0 mg/kg) | 100.0 |
| Venofer (2.0 mg/kg) | 97.5 |
Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive
Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive (NCT00239642)
Timeframe: anytime during the 12 week post-baseline period
| Intervention | percentage of subjects (Number) |
|---|
| Venofer (0.5 mg/kg) | 100.0 |
| Venofer (1.0 mg/kg) | 95.6 |
| Venofer (2.0 mg/kg) | 95.0 |
Hemoglobin Concentration at 6 Months
(NCT00318812)
Timeframe: 6 months
| Intervention | g/L (Median) |
|---|
| Heme Iron | 117 |
| Iron Sucrose | 113 |
Ferritin
Comparison of Ferritin at 6 months between the 2 Groups (NCT00318812)
Timeframe: 6 months
| Intervention | ug/L (Median) |
|---|
| Heme Iron | 85.5 |
| Iron Sucrose | 244 |
Transferrin Saturation
Comparison of Transferrin Saturation between the Groups (NCT00318812)
Timeframe: 6 Months
| Intervention | percentage of bound iron sites (Median) |
|---|
| Heme Iron | 21.5 |
| Iron Sucrose | 21.5 |
Incidence of Diarrhea
A diarrhea episode was defined as three or more loose, liquid, or watery stools for 2 consecutive days, separated in time from an earlier or subsequent episode by at least 2 consecutive diarrhea-free days. (NCT00470158)
Timeframe: 6 months
| Intervention | episodes (Number) |
|---|
| Combined Iron and Zinc | 201 |
| Separate Iron and Zinc | 204 |
| Iron Alone | 260 |
| Zinc Alone | 224 |
| Placebo | 235 |
Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group.
Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL (NCT00548249)
Timeframe: Up to 26 weeks
| Intervention | Days (Number) |
|---|
| 5th Percentile | 10th Percentile | 15th Percentile | 20th Percentile | 25th Percentile |
|---|
| 0 µg Iron/dL of Dialysate | 59 | 94 | 94 | 115 | 115 |
,| 10 µg Iron/dL of Dialysate | 10 | 106 | 106 | 106 | 115 |
,| 12 µg Iron/dL of Dialysate | 31 | 45 | 115 | 115 | 150 |
,| 15 µg Iron/dL of Dialysate | 31 | 31 | 38 | 80 | 94 |
,| 5 µg Iron/dL of Dialysate | 24 | 31 | 66 | 87 | 108 |
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks). (NCT00548249)
Timeframe: Every 4 weeks
| Intervention | pg (Mean) |
|---|
| Baseline Reticulocyte Hemoglobin | Reticulocyte Hemoglobin/ Week 1 | Reticulocyte Hemoglobin/ Week 4 | Reticulocyte Hemoglobin/ Week 8 | Reticulocyte Hemoglobin/ Week 12 | Reticulocyte Hemoglobin/ Week 16 | Reticulocyte Hemoglobin/ Week 20 | Reticulocyte Hemoglobin/ Week 24 | Reticulocyte Hemoglobin/ Week 26 | Reticulocyte Hemoglobin/ End of Trial | Reticulocyte Hemoglobin/ Final Evaluation |
|---|
| 0 µg Iron/dL of Dialysate | 32.55 | 32.42 | 32.00 | 32.14 | 31.83 | 31.45 | 31.13 | 30.93 | 30.78 | 30.06 | 31.85 |
,| 10 µg Iron/dL of Dialysate | 32.86 | 32.69 | 32.69 | 32.75 | 32.78 | 33.05 | 32.81 | 32.08 | 32.20 | 31.46 | 32.19 |
,| 12 µg Iron/dL of Dialysate | 32.34 | 31.87 | 31.82 | 31.75 | 31.82 | 31.86 | 30.68 | 30.53 | 30.72 | 30.55 | 31.65 |
,| 15 µg Iron/dL of Dialysate | 32.64 | 32.40 | 32.05 | 32.35 | 32.48 | 32.25 | 31.64 | 31.40 | 30.43 | 30.11 | 32.13 |
,| 5 µg Iron/dL of Dialysate | 32.98 | 32.58 | 32.27 | 32.28 | 32.13 | 31.95 | 31.81 | 31.85 | 31.32 | 31.50 | 31.68 |
Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements.
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization). (NCT00548249)
Timeframe: up to 26 weeks
| Intervention | Percent of subjects (Number) |
|---|
| 0 µg Iron/dL of Dialysate | 5 |
| 5 µg Iron/dL of Dialysate | 6 |
| 10 µg Iron/dL of Dialysate | 5 |
| 12 µg Iron/dL of Dialysate | 4 |
| 15 µg Iron/dL of Dialysate | 10 |
Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.
(NCT00548249)
Timeframe: At each dialysis session for up to 26 weeks
| Intervention | Subjects (Number) |
|---|
| 0 µg Iron/dL of Dialysate | 2 |
| 5 µg Iron/dL of Dialysate | 1 |
| 10 µg Iron/dL of Dialysate | 2 |
| 12 µg Iron/dL of Dialysate | 0 |
| 15 µg Iron/dL of Dialysate | 1 |
Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.
(NCT00548249)
Timeframe: two separate sessions measured one week apart.
| Intervention | Subjects (Number) |
|---|
| 0 µg Iron/dL of Dialysate | 6 |
| 5 µg Iron/dL of Dialysate | 6 |
| 10 µg Iron/dL of Dialysate | 9 |
| 12 µg Iron/dL of Dialysate | 7 |
| 15 µg Iron/dL of Dialysate | 8 |
Change From Baseline in Hemoglobin (Hgb)
(NCT00548249)
Timeframe: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)
| Intervention | grams/ deciliter (g/dL) (Mean) |
|---|
| 0 µg Iron/dL of Dialysate | -0.177 |
| 5 µg Iron/dL of Dialysate | 0.258 |
| 10 µg Iron/dL of Dialysate | 0.462 |
| 12 µg Iron/dL of Dialysate | 0.173 |
| 15 µg Iron/dL of Dialysate | -0.018 |
Ferritin Change Before and After 4 Weeks of Treatment/Placebo
Level of ferritin measured 4 weeks after randomization (NCT00689793)
Timeframe: baseline and 4 weeks
| Intervention | ng/mL (Mean) |
|---|
| Oral Treatment of Iron | 28.0 |
| Placebo | 12.9 |
Adherence to Treatment.
Adherence to treatment was calculated as the number of days with at least one opening of the electronic device divided by the total number of monitored days. The device was a MEMS (Medication Event Monitoring System,AARDEX, Europe, Switzerland) (NCT00689793)
Timeframe: 4 weeks
| Intervention | percentage of day (Mean) |
|---|
| Oral Treatment of Iron | 96 |
| Placebo | 96 |
Aerobic Capacity Using an Indirect Measurement of VO2Max : Chester Step Test
Subjects were asked to step on to and off a 20cm step at a rate set by a metronome. Step rate increased gradually until subject reached her submaximal predicted heart rate. (NCT00689793)
Timeframe: baseline and 4 weeks
| Intervention | mLO2/kg/min (Mean) |
|---|
| Oral Treatment of Iron | 40.5 |
| Placebo | 40.1 |
Hemoglobin Variation Before and After Treatment vs Placebo
The level of hemoglobin measured 4 weeks after randomization (NCT00689793)
Timeframe: baseline and 4 weeks
| Intervention | g/L (Mean) |
|---|
| Oral Treatment of Iron | 135 |
| Placebo | 130 |
Level of Fatigue Before and After Iron Treatment/Placebo, Using a 10 Point Visual Analogue Scale.
"The level of fatigue perceived at baseline and after 4 weeks was scored on a 10-point visual analogue scale ranging from no fatigue=0 to very severe fatigue=10." (NCT00689793)
Timeframe: baseline and 4 weeks
| Intervention | centimeter (Mean) |
|---|
| Oral Treatment of Iron | 3.4 |
| Placebo | 3.5 |
Response of Iron Supplementation on Mental Disorder
Depression was assessed using the Prime-MD Patient Health Questionnaire (PHQ-9), self-administered by the subject.Diagnosis of depression syndrom was made scoring results of the nine item (range : 0-3). A score >15 (range of total overall scale:0-27) was considered as a depression syndrome. The outcome measure is the number the donors with a depression syndrome at baseline who had a positive response (total score= or <15) after placebo or treatment. (NCT00689793)
Timeframe: baseline and 4 weeks
| Intervention | participants (Number) |
|---|
| Oral Treatment of Iron | 3 |
| Placebo | 4 |
Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit)
Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes. (NCT00755755)
Timeframe: Week 13
| Intervention | percentage of change (Median) |
|---|
| A (PGL4001 5mg) | -21.2 |
| B (PGL4001 10mg) | -12.3 |
| C (Placebo) | 3 |
Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13)
"Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss.~Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding.~A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5.~Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used.~The week 13 PBAC score was calculated using the last 28 days of treatment." (NCT00755755)
Timeframe: Week 13 visit
| Intervention | percentage of patients (Number) |
|---|
| A (PGL4001 5mg) | 91.5 |
| B (PGL4001 10mg) | 92.5 |
| C (Placebo) | 18.8 |
Change From Baseline in Serum-phosphate Levels at Week 4
(NCT00824460)
Timeframe: 4 weeks after baseline
| Intervention | mmol/L (Mean) |
|---|
| 1.25 g PA21 (250 mg Iron) | -0.03 |
| 5.0g PA21 (1,000 mg Iron) | -0.39 |
| 7.5 g PA21 (1,500 mg Iron) | -0.32 |
| 10.0 g PA21 (2,000 mg Iron) | -0.58 |
| 12.5g PA21 (2,500 mg Iron) | -0.53 |
| Sevelamer Hydrochloride - Active Control | -0.53 |
Change From Baseline in Serum-phosphate Levels at Week 2
(NCT00824460)
Timeframe: 2 weeks after baseline
| Intervention | mmol/L (Mean) |
|---|
| 1.25 g PA21 (250 mg Iron) | -0.03 |
| 5.0 g PA21 (1,000 mg Iron) | -0.36 |
| 7.5 g PA21 (1,500 mg Iron) | -0.41 |
| 10.0 g PA21 (2,000 mg Iron) | -0.47 |
| 12.5 g PA21 (2,500 mg Iron) | -0.46 |
| Sevelamer Hydrochloride - Active Control | -0.41 |
Change From Baseline in Serum-phosphate Levels at the End of Treatment.
(NCT00824460)
Timeframe: 6 weeks after baseline
| Intervention | mmol/L (Mean) |
|---|
| 1.25 g PA21 (250 mg Iron) | -0.042 |
| 5.0 g PA21 (1,000 mg Iron) | -0.348 |
| 7.5 g PA21 (1,500 mg Iron) | -0.404 |
| 10.0 g PA21 (2,000 mg Iron) | -0.644 |
| 12.5g PA21 (2,500 mg Iron) | -0.547 |
| Sevelamer Hydrochloride - Active Control | -0.341 |
Change From Baseline in Serum-phosphate Levels at Week 5
(NCT00824460)
Timeframe: 5 weeks after baseline
| Intervention | mmol/L (Mean) |
|---|
| 1.25 g PA21 (250 mg Iron) | -0.05 |
| 5.0 g PA21 (1,000 mg Iron) | -0.51 |
| 7.5 g PA21 (1,500 mg Iron) | -0.40 |
| 10.0 g PA21 (2,000 mg Iron) | -0.57 |
| 12.5 g PA21 (2,500 mg Iron) | -0.58 |
| Sevelamer Hydrochloride - Active Control | -0.52 |
Still Birth Rates
Stillbirth (born >=24 weeks without breathing, crying, or moving limbs). (NCT00860470)
Timeframe: 24 weeks gestation to delivery
| Intervention | participants (Number) |
|---|
| Iron and Folate | 716 |
| Multiple Micronutrient | 648 |
Very Pre-term
Birth between 28 and 32 weeks of gestation (NCT00860470)
Timeframe: Between 27 and 33 weeks of gestation
| Intervention | participants (Number) |
|---|
| Iron and Folate | 385 |
| Multiple Micronutrient | 291 |
Moderate to Late Preterm
Birth between 32 and 37 weeks gestation (NCT00860470)
Timeframe: Between 31 and 38 weeks of gestation
| Intervention | participants (Number) |
|---|
| Iron and Folate | 2391 |
| Multiple Micronutrient | 2113 |
Preterm Birth
Being born before 37 weeks of gestation (NCT00860470)
Timeframe: Up to 37 weeks of gestation
| Intervention | participants (Number) |
|---|
| Iron and Folate | 2912 |
| Multiple Micronutrient | 2510 |
Low Birth Weight
Birth weight below 2500g (NCT00860470)
Timeframe: Measured at delivery/birth
| Intervention | participants (Number) |
|---|
| Iron and Folate | 4809 |
| Multiple Micronutrient | 4275 |
Extremely Pre-term
Birth before 28 weeks gestation (NCT00860470)
Timeframe: Up to 28 weeks of gestation
| Intervention | participants (Number) |
|---|
| Iron and Folate | 136 |
| Multiple Micronutrient | 106 |
Infant Mortality Through 6 mo of Age
Infant Mortality to Age 6 months (180 days from birth) (NCT00860470)
Timeframe: 6-months post-birth
| Intervention | participants (Number) |
|---|
| Iron and Folate | 764 |
| Multiple Micronutrient | 741 |
Small for Gestation Age
Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68). (NCT00860470)
Timeframe: At delivery/birth
| Intervention | participants (Number) |
|---|
| Iron and Folate | 6479 |
| Multiple Micronutrient | 6405 |
Neonatal Mortality
Neonatal Mortality (28 days of life) (NCT00860470)
Timeframe: 1 month post-birth
| Intervention | participants (Number) |
|---|
| Iron and Folate | 625 |
| Multiple Micronutrient | 626 |
Post-neonatal Mortality
Risk of Post-neonatal Mortality (29th -180th day of life) (NCT00860470)
Timeframe: 1-6 months post-birth
| Intervention | participants (Number) |
|---|
| Iron and Folate | 139 |
| Multiple Micronutrient | 115 |
Mean Change From Baseline to Day 84 for International Restless Leg Syndrome Study Group (IRLSSG) Scale
Validated rating scale of RLS symptoms (Range 1 [mild] - 40 [severe]) (NCT00895232)
Timeframe: Baseline to Day 84
| Intervention | units on a scale (Mean) |
|---|
| Cohort I (Venofer 500mg x 1 Dose) | -2.4 |
| Cohort II (Venofer 500mg X 2 Doses) | -14.3 |
| Cohort III (Venofer 500mg x 2 Doses) | -16.0 |
Mean Change From Baseline to Day 84 for Total Periodic Limb Movements (PLM's)
Quantifies amount of leg movement (NCT00895232)
Timeframe: Baseline to Day 84
| Intervention | PLM's per hour (Mean) |
|---|
| Cohort I (Venofer 500mg x 1 Dose) | -7.2 |
| Cohort II (Venofer 500mg X 2 Doses) | -75.0 |
| Cohort III (Venofer 500mg x 2 Doses) | -96.2 |
Percentage (%) of Subjects Responding to Treatment From Baseline to Day 84 Based on Global Assessments by the Examiner.
Response is defined as any effect based on a scale of 0 through 4 where 0 = no effect, 1 = mild effect, 2 = moderate effect, 3 = marked effect, and 4 = dramatic effect. (NCT00895232)
Timeframe: Baseline to Day 84
| Intervention | percent of participants (Number) |
|---|
| Cohort I (Venofer 500mg x 1 Dose) | 28.6 |
| Cohort II (Venofer 500mg X 2 Doses) | 66.7 |
| Cohort III (Venofer 500mg x 2 Doses) | 66.7 |
Candida Culture Free After Maintenance Therapy
candida culture free (monthly vaginal cultures were obtained) (NCT00895453)
Timeframe: 12 months
| Intervention | participants (Number) |
|---|
| Itraconazole | 18 |
| Itraconazole + Lactobacillus Gasseri | 19 |
| Classic Homeopathy | 9 |
Number of Participants Who Received Red Cell Transfusions During Intervention Period
The numbers below represent the number of participants in each arm that received a transfusion during intervention period. (NCT01125163)
Timeframe: from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner
| Intervention | participants (Number) |
|---|
| Multivitamin With Iron | 48 |
| Multivitamin Without Iron | 54 |
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome. (NCT01125163)
Timeframe: at 36 weeks adjusted postmenstrual age
| Intervention | % Hematocrit (Mean) |
|---|
| Multivitamin With Iron | 29.2 |
| Multivitamin Without Iron | 28.2 |
Change in Hemoglobin From Baseline to Week 24
(NCT01145638)
Timeframe: 24 weeks
| Intervention | g/dL (Mean) |
|---|
| Iron Isomaltoside 1000 | 1.60 |
| Iron Sulphate | 1.78 |
Change in Hb Concentration
(NCT01145638)
Timeframe: Baseline week 4
| Intervention | g/dL (Mean) |
|---|
| Iron Isomaltoside 1000 | 0.48 |
| Iron Sulphate | 0.44 |
Haemoglobin Level
Haemoglobin level (g/L) measured by cyanmethaemoglobin method (NCT01198574)
Timeframe: at week 0, week 6 and week12
| Intervention | g/L (Mean) |
|---|
| Hb week 0 (Baseline) | Hb week 6 (Midline) | Hb week 12 (Endline) |
|---|
| Iron and Vitamin A Group | 88.4 | 99.2 | 111.4 |
,| Iron Group | 88.3 | 98.1 | 110.8 |
,| Placebo Group | 89.6 | 98.3 | 109.7 |
,| Vitamin A Group | 89.2 | 98.7 | 109.0 |
Status of Tissue Iron Store
Tissue iron store was measured by serum ferritin (NCT01198574)
Timeframe: at week 0, week 6 and week12
| Intervention | µg/L (Geometric Mean) |
|---|
| serum ferritin (Baseline) | serum ferritin (Midline) | serum ferritin (Endline) |
|---|
| Iron and Vitamin A Group | 25.9 | 32.3 | 35.4 |
,| Iron Group | 32.1 | 34.5 | 39.6 |
,| Placebo Group | 31.1 | 26.5 | 28.2 |
,| Vitamin A Group | 34.4 | 32.1 | 35.0 |
Status of Cellular Iron Deficiency
Cellular Iron deficiency status is also measured by serum transferrin receptor (NCT01198574)
Timeframe: at week 0, week 6 and week12
| Intervention | mg/L (Geometric Mean) |
|---|
| serum transferrin receptor (Baseline) | serum transferrin receptor (Midline) | serum transferrin receptor (Endline) |
|---|
| Iron and Vitamin A Group | 7.16 | 6.73 | 6.24 |
,| Iron Group | 7.09 | 6.69 | 6.44 |
,| Placebo Group | 6.74 | 6.59 | 6.61 |
,| Vitamin A Group | 6.56 | 6.39 | 6.27 |
Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Higher numbers indicated a better response.There is no scale, as the results are normalized variables. (NCT01309659)
Timeframe: Baseline, 12 week
| Intervention | change in Z-score (Mean) |
|---|
| Immediate Intervention Group | 0.41 |
| Wait List Control | 1.39 |
Change in Cognitive Outcome Measures as Determined by Speed of Processing
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. (NCT01309659)
Timeframe: Baseline, 12 Week
| Intervention | change in Z-Score (Mean) |
|---|
| Immediate Intervention Group | 0.62 |
| Wait List Control | 1.08 |
Change in Cognitive Outcome Measures as Determined by Trail Making Test Part B
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to week 12. (NCT01309659)
Timeframe: Baseline, 12 weeks
| Intervention | change in seconds per completed circle (Mean) |
|---|
| Immediate Intervention Group | -0.77 |
| Wait List Control | -4.96 |
Change in Frailty Component as Determined by Grip Strength
"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at week 12). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12." (NCT01309659)
Timeframe: Baseline, 12 weeks
| Intervention | participants (Number) |
|---|
| Immediate Intervention Group | 0 |
| Wait List Control | 0 |
Change in Frailty Component as Determined by the 4 Meter Walk Speed
"To quantify the impact of anemia treatment by IV iron sucrose on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at week 12). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12." (NCT01309659)
Timeframe: Baseline, 12 weeks
| Intervention | participants (Number) |
|---|
| Immediate Intervention Group | 0 |
| Wait List Control | 0 |
Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score
To quantify the impact of anemia treatment by IV iron sucrose on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 12 weeks. Scores range from 0-188 with higher scores indicating better function. (NCT01309659)
Timeframe: Baseline, 12 weeks
| Intervention | change in the total score (Mean) |
|---|
| Immediate Intervention Group | 10.6 |
| Wait List Control | 0.0 |
Change in the Frailty Component as Determined by Self-reported Activity Level
"To quantify the impact of anemia treatment by IV iron sucrose on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as frail at baseline and changed to not frail at week 12." (NCT01309659)
Timeframe: Baseline, 12 week
| Intervention | participants (Number) |
|---|
| Immediate Intervention Group | 0 |
| Wait List Control | 0 |
Correlation Between Baseline Soluble Transferrin Receptor and the Change in HB From Baseline to 12 Weeks
Correlation between baseline soluble transferrin receptor and the change in hemoglobin from the baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks
| Intervention | correlation coefficient (Number) |
|---|
| Immediate Intervention Group | -0.192 |
| Wait List Control | -0.886 |
Correlation Between Baseline Soluble Transferrin Receptor and the Change in the 6 Meter Walk Test Distance
Correlation between baseline soluble transferrin receptor and the change in the 6 Meter Walk Test distance from baseline to 12 weeks (NCT01309659)
Timeframe: baseline, 12 weeks
| Intervention | correlation coefficient (Number) |
|---|
| Immediate Intervention Group | 0.192 |
| Wait List Control | 0.349 |
Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in the 6 Minute Walk Test Distance
Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in the 6 Minute Walk Test Distance from baseline to 12 weeks (NCT01309659)
Timeframe: baseline, 12 weeks
| Intervention | correlation coefficient (Number) |
|---|
| Immediate Intervention Group | -0.300 |
| Wait List Control | 0.486 |
Number of Participants Who Had a Hemoglobin Increase >= 1g/dL
To assess the efficacy of IV iron sucrose in improving Hemoglobin by at least 1 g/dL; an increase from baseline to week 12. (NCT01309659)
Timeframe: baseline, 12 weeks
| Intervention | participants (Number) |
|---|
| Immediate Intervention Group | 1 |
| Wait List Control | 0 |
Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in 6 Minute Walk Test Distance
Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in 6 Minute Walk Test distance from baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks
| Intervention | correlation coefficient (Number) |
|---|
| Correlation for ferritin | Correlation for iron | Correlation TSAT |
|---|
| Immediate Intervention Group | 0.617 | 0.332 | 0.400 |
,| Wait List Control | 0.100 | -0.133 | -0.350 |
Correlation Between Baseline Serum Ferritin, Serum Iron, and Transferrin Saturation and the Change in Hemoglobin (HB)
Correlation between baseline serum ferritin, serum iron, and transferrin saturation and the change in HB from baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks
| Intervention | correlation coefficient (Number) |
|---|
| Correlation btw baseline ferritin & change in Hgb | Correlation btw baseline iron & change in Hgb | Correlation btw baseline TST & change in Hgb |
|---|
| Immediate Intervention Group | 0.383 | 0.323 | 0.200 |
,| Wait List Control | 0.189 | 0.541 | 0.584 |
Change in 6 Minute Walk Test Results
Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters at baseline (time of randomization) and 12 weeks after baseline (time of randomization). The change from baseline to 12 weeks, related to distance, is compared and documented. (NCT01309659)
Timeframe: Baseline, 12 weeks
| Intervention | meters (Mean) |
|---|
| Immediate Intervention Group | 8.05 |
| Wait List Control | -11.45 |
Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing
To quantify the impact of anemia treatment by IV iron sucrose on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test. (NCT01309659)
Timeframe: Baseline, 12 week
| Intervention | change in Z-score (Mean) |
|---|
| Immediate Intervention Group | 0.36 |
| Wait List Control | 0.69 |
Correlation Between Baseline Soluble Transferrin Receptor Index (Soluble Receptor/Log Ferritin) and the Change in Hemoglobin
Correlation between baseline soluble transferrin receptor index (soluble receptor/log ferritin) and the change in hemoglobin from baseline to 12 weeks. (NCT01309659)
Timeframe: baseline, 12 weeks
| Intervention | correlation coefficient (Number) |
|---|
| Immediate Intervention Group | -0.500 |
| Wait List Control | -0.714 |
Change in Serum Phosphorus Levels From Baseline to Week 12
Change in serum phosphorus levels from baseline to Week 12 in the PA21 group versus the sevelamer group. (NCT01324128)
Timeframe: Week 12 post Baseline
| Intervention | mg/dL (Least Squares Mean) |
|---|
| PA21 (2.5 g Tablet) Stage 1 | -2.19 |
| Sevelamer Carbonate Stage 1 | -2.45 |
Change in Serum Phosphorus Levels From Week 24 to Week 27
Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27 (NCT01324128)
Timeframe: Week 24, Week 27
| Intervention | mg/dL (Least Squares Mean) |
|---|
| PA21 (MD) Stage 2 | 0.25 |
| PA21-1 (LD) Stage 2 | 1.92 |
Number of Participants With a Hb Response, Defined as an Increase in Hb by ≥1.0 g/dL From Baseline, by Weeks 5, 9, and 13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Weeks 5, 9, and 13
| Intervention | Participants (Count of Participants) |
|---|
| Week 5 | Week 9 | Week 13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 21 | 22 | 22 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 9 | 10 | 11 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 7 | 9 | 10 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 7 | 9 | 10 |
Number of Participants Requiring Therapeutic Phlebotomy
Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported. (NCT01414075)
Timeframe: Baseline up to Week 13
| Intervention | Participants (Count of Participants) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 0 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 1 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 |
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥10.0 g/dL
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Week 3 to 13
| Intervention | Participants (Count of Participants) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 17 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 10 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 8 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 10 |
Number of Participants Whose Maximum Hb Achieved During Treatment Was at Least 1.0 g/dL Increase From Baseline and Was ≥11.0 g/dL
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Week 3 to 13
| Intervention | Participants (Count of Participants) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 10 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 8 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 8 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 9 |
Number of Participants With Mean Hb Values Within 10.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥10.0 g/dL and Change of Hb ≥1 g/dL
(NCT01414075)
Timeframe: Weeks 10-13
| Intervention | Participants (Count of Participants) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 15 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 7 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 7 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 9 |
Number of Participants With Mean Hb Values Within 11.0-13.0 g/dL During Weeks 10-13 Among Those With Maximum Hb ≥11.0 g/dL and Change of Hb ≥1 g/dL
(NCT01414075)
Timeframe: Weeks 10-13
| Intervention | Participants (Count of Participants) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 5 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 2 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 5 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 7 |
Number of Participants With TEAEs
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT01414075)
Timeframe: Baseline up to Week 16
| Intervention | Participants (Count of Participants) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 16 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 6 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 3 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 5 |
Number of Participants Withdrawn From the Study Due to Inadequate Efficacy
Number of participants withdrawn from the study due to inadequate efficacy is reported. (NCT01414075)
Timeframe: Baseline up to Week 16
| Intervention | Participants (Count of Participants) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 0 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 |
Weekly Dose at First Hb Response (Increase in Hb by ≥1.0 g/dL From Baseline)
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Baseline up to Week 13
| Intervention | mg/kg (Mean) |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 4.2 |
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 4.2 |
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 4.5 |
| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 4.3 |
Change From Baseline in Ferritin at Week 13
Baseline was defined as the average of the last 2 values prior to the first dose administration. (NCT01414075)
Timeframe: Baseline, Week 13
| Intervention | micrograms/liter (µg/L) (Mean) |
|---|
| Baseline | Change at Week 13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 156.4 | -119.7 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 162.5 | -51.1 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 182.0 | -25.2 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 137.4 | -65.1 |
Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13
FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration. (NCT01414075)
Timeframe: Baseline, Weeks 9 and 13
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 123.5 | 8.2 | 7.3 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 118.9 | 4.0 | 5.9 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 128.8 | 1.9 | 5.1 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 122.8 | 12.8 | 12.9 |
Change From Baseline in Reticulocyte Hemoglobin Content at Week 13
(NCT01414075)
Timeframe: Baseline, Week 13
| Intervention | picogram (pg) (Mean) |
|---|
| Baseline | Change at Week 13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 31.0 | -2.2 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 31.6 | -1.9 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 31.5 | -1.0 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 30.4 | -0.2 |
Change From Baseline in Transferrin Saturation (TSAT) at Week 13
(NCT01414075)
Timeframe: Baseline, Week 13
| Intervention | percentage of transferrin (Mean) |
|---|
| Baseline | Change at Week 13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 18.8 | -7.4 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 19.0 | 2.6 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 18.1 | 0.7 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 19.3 | -1.6 |
Maximum Change From Baseline in Hb During Weeks 3-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. This outcome measure is derived from the maximum change from baseline during Weeks 3-13, without last observation carried forward (LOCF) imputation. (NCT01414075)
Timeframe: Baseline, Weeks 3-13
| Intervention | grams/deciliter (g/dL) (Mean) |
|---|
| Baseline | Change at Weeks 3-13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 8.1 | 2.8 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 8.5 | 3.5 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 8.4 | 3.5 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 8.7 | 3.3 |
Mean Change From Baseline in Hb During Weeks 2-5, 6-9, and 10-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. (NCT01414075)
Timeframe: Baseline, Weeks 2-5, 6-9, and 10-13
| Intervention | g/dL (Mean) |
|---|
| Baseline | Change at Weeks 2-5 | Change at Weeks 6-9 | Change at Weeks 10-13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 8.1 | 1.1 | 2.0 | 2.1 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 8.5 | 1.1 | 2.3 | 2.7 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 8.4 | 1.0 | 2.0 | 3.0 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 8.7 | 0.8 | 1.8 | 2.4 |
Number of Participants Requiring Dose Increase at Weeks 5 and 9
Number of participants requiring dose increase due to any reasons is reported. (NCT01414075)
Timeframe: Weeks 5 and 9
| Intervention | Participants (Count of Participants) |
|---|
| Week 5 | Week 9 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 2 | 8 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 3 | 5 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 2 | 3 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 4 | 5 |
Number of Participants Requiring Dose Reduction or Dose Discontinuation Due to Excessive Erythropoiesis
Number of participants requiring dose reduction or dose discontinuation due to excessive erythropoiesis is reported. (NCT01414075)
Timeframe: Weeks 5 and 9
| Intervention | Participants (Count of Participants) |
|---|
| Dose reduced at Week 5 | Dose interrupted at Week 5 | Dose reduced at Week 9 | Dose interrupted at Week 9 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 3 | 1 | 1 | 1 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 5 | 0 | 0 | 0 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 3 | 0 | 3 | 0 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 5 | 0 | 0 | 1 |
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)
Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. (NCT01414075)
Timeframe: Baseline up to Week 13
| Intervention | Participants (Count of Participants) |
|---|
| Blood transfusion for severe anemia | Blood transfusion for gastrointestinal bleeding |
|---|
| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 1 | 0 |
Number of Participants Requiring Rescue Treatment With an Erythropoiesis-Stimulating Agent (ESA), Red Blood Cells (RBC) Transfusion, or IV Iron (Excluding Arm C)
Number of participants requiring rescue treatment with an ESA, RBC transfusion, or IV Iron (Excluding Arm C) was reported. (NCT01414075)
Timeframe: Baseline up to Week 13
| Intervention | Participants (Count of Participants) |
|---|
| Blood transfusion for severe anemia | Blood transfusion for gastrointestinal bleeding | IV iron for acute iron deficiency | IV iron for a treatment-emergent adverse event (TEAE) of thrombocytosis |
|---|
| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 0 | 0 | 0 |
,| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 0 | 1 | 1 | 1 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 0 | 0 | 0 |
Number of Participants Who Achieved Maximum Hb During Weeks 3-13
(NCT01414075)
Timeframe: Weeks 3-13
| Intervention | Participants (Count of Participants) |
|---|
| <10 g/dL | 10 to <11 g/dL | 11 to 13 g/dL | >13 to 14 g/dL | >14 g/dL |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 6 | 7 | 10 | 0 | 0 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 1 | 3 | 5 | 1 | 2 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 2 | 0 | 5 | 3 | 0 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 1 | 9 | 0 | 0 |
Number of Participants With a Maximum Change From Baseline in Hb During Weeks 3-13
Baseline Hb was defined as the mean of the last 3 central laboratory Hb values prior to the first dose administration. The number of participants who fall within the following categories of maximum change are reported: <1 g/dL, ≥1 g/dL, 1 to <2 g/dL, 2 to <3 g/dL, >3 to <4 g/dL, ≥4 g/dL. (NCT01414075)
Timeframe: Baseline, Weeks 3-13
| Intervention | Participants (Count of Participants) |
|---|
| <1 g/dL | ≥1 g/dL | 1 to <2 g/dL | 2 to <3 g/dL | >3 to <4 g/dL | ≥4 g/dL |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 1 | 22 | 4 | 9 | 7 | 2 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 1 | 11 | 2 | 2 | 2 | 5 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 | 10 | 2 | 0 | 4 | 4 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 10 | 0 | 5 | 3 | 2 |
Number of Participants With Mean Hb Values <10.0 g/dL at Weeks 6-9 and 10-13
(NCT01414075)
Timeframe: Weeks 6-9 and 10-13
| Intervention | Participants (Count of Participants) |
|---|
| Week 6-9 | Week 10-13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 10 | 8 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 4 | 3 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 2 | 2 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 3 | 1 |
Number of Participants With Mean Hb Values 11.0-13.0 g/dL at Weeks 6-9 and 10-13
(NCT01414075)
Timeframe: Weeks 6-9 and 10-13
| Intervention | Participants (Count of Participants) |
|---|
| Weeks 6-9 | Weeks 10-13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 6 | 5 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 5 | 2 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 4 | 5 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 5 | 7 |
Number of Participants With Mean Hb Values in Excess of 13.0 and 14.0 g/dL at Weeks 6-9 and 10-13
(NCT01414075)
Timeframe: Weeks 6-9 and 10-13
| Intervention | Participants (Count of Participants) |
|---|
| Week 6-9 | Week 10-13 |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 0 | 0 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 1 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 | 1 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 0 |
Number of Participants With Potentially Clinically Significant Laboratory Tests
Criteria for the potential clinical significance included: bilirubin (µmol/L) >1.5 * upper limit of normal (ULN), potassium (mmol/L) >1.2 * ULN, neutrophils (*10^9/L) ≤1, protein (g/L) >1.1 * ULN, leukocytes (*10^9/L) ≤2.5 or ≥15. (NCT01414075)
Timeframe: Baseline up to Week 16
| Intervention | Participants (Count of Participants) |
|---|
| Bilirubin | Potassium | Neutrophils | Protein | Leukocytes |
|---|
| Arm A + E (Participants on HD): Roxadustat Only, No Iron | 1 | 2 | 0 | 1 | 1 |
,| Arm B (Participants on HD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 1 | 1 | 0 | 0 |
,| Arm C (Participants on HD): IV Iron (Ferric Gluconate Complex in Sucrose or Equivalent) 60 mg | 0 | 0 | 1 | 0 | 1 |
,| Arm D (Participants on PD): PO Iron (Ferrous Fumarate or Ferrous Gluconate) Between 50 and 195 mg | 0 | 1 | 0 | 0 | 0 |
Hemoglobin Concentration Over Time
The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment. The primary analysis consists of a linear mixed regression model, which incorporates all subsequent time points into the model and includes treatment and time as covariates and patient random effects to account for correlation among longitudinal measurements from the same patients. (NCT01904864)
Timeframe: 12 weeks
| Intervention | g/dL (Mean) |
|---|
| Baseline | 4 Weeks | 8 Weeks | 12 Weeks |
|---|
| Ferrous Sulfate | 7.9 | 10.4 | 11.4 | 11.9 |
,| NovaFerrum® (Iron Polysaccharide Complex) | 7.7 | 9.3 | 10.5 | 11.1 |
Serum Ferritin
Serum levels of ferritin (NCT01975272)
Timeframe: 3 weeks postoperative
| Intervention | microgram/L (Mean) |
|---|
| Ferinject | 422 |
| Ferrous Fumarate | 57 |
| Placebo Infusion and Tablets | 37 |
Serum Hepcidin
Serum hepcidin level (NCT01975272)
Timeframe: 3 weeks postoperative
| Intervention | nmol/L (Mean) |
|---|
| Ferinject | 11.6 |
| Ferrous Fumarate | 2.2 |
| Placebo Infusion and Tablets | 1.7 |
Hemoglobin
Serum hemoglobin level (NCT01975272)
Timeframe: 3 weeks postoperative
| Intervention | mmol/L (Mean) |
|---|
| Ferinject | 8.4 |
| Ferrous Fumarate | 7.9 |
| Placebo Infusion and Tablets | 7.1 |
Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).
(NCT02038023)
Timeframe: 4 weeks after infusion or post-partum
| Intervention | Participants (Count of Participants) |
|---|
| Improvement of > or equal to 1 g/dL | Improvement of > or equal to 2 g/dL |
|---|
| Iron Deficient Gravidas | 35 | 11 |
Serum Ferritin
(NCT02038023)
Timeframe: 4 weeks post infusion or post-partum
| Intervention | ng/mL (Mean) |
|---|
| Intravenous Iron | 126.29 |
Safety as Measured by Number of Adverse Events
To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days. (NCT02038023)
Timeframe: 4 weeks after infusion and 4 weeks post-partum
| Intervention | minor adverse events (Number) |
|---|
| Only One Group[ | 6 |
Percent Transferrin Saturation
(NCT02038023)
Timeframe: 4 weeks post infusion or post-partum
| Intervention | percent saturation (Fe/TIBC) (Mean) |
|---|
| Iron Deficient Gravidas | 22.64 |
Change in Transferrin Saturation (TSAT)
(NCT02130063)
Timeframe: From baseline to week 1, 2, 4, and 5
| Intervention | percent (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 5 |
|---|
| Iron Isomaltoside 1000 (Monofer®) | 15.7 | 17.9 | 16.3 | 15.6 |
,| Iron Sucrose (Venofer®) | 3.3 | 5.7 | 11.5 | 11.8 |
Change in Hb Concentration
(NCT02130063)
Timeframe: From baseline to week 2, 4 and 5
| Intervention | g/dL (Mean) |
|---|
| Week 2 | Week 4 | Week 5 |
|---|
| Iron Isomaltoside 1000 (Monofer®) | 1.56 | 2.35 | 2.52 |
,| Iron Sucrose (Venofer®) | 0.87 | 1.74 | 2.05 |
Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5
"The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder.~Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised." (NCT02130063)
Timeframe: From baseline to week 5
| Intervention | participants (Number) |
|---|
| Iron Isomaltoside 1000 (Monofer®) | 226 |
| Iron Sucrose (Venofer®) | 83 |
Change in Serum (s)-Ferritin Concentration
(NCT02130063)
Timeframe: From baseline to week 1, 2, 4, and 5
| Intervention | ng/mL (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 5 |
|---|
| Iron Isomaltoside 1000 (Monofer®) | 431.2 | 516.6 | 285.3 | 241.2 |
,| Iron Sucrose (Venofer®) | 86.9 | 126.2 | 195.0 | 185.7 |
Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. (NCT02151643)
Timeframe: Day 1 to Day 29
| Intervention | percent (Mean) |
|---|
| Group 1 - PT20 400 mg Tid | 2.20 |
| Group 2 - PT20 800 mg Tid | 0.40 |
| Group 3 - PT20 1600 mg Tid | 5.84 |
| Group 4 - PT20 3200 mg Tid | -4.59 |
| Group 5 - Placebo Tid | -0.45 |
Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory. (NCT02151643)
Timeframe: Day 1 to Day 29
| Intervention | mg/dL (Mean) |
|---|
| Group 1 - PT20 400 mg Tid | -0.4 |
| Group 2 - PT20 800 mg Tid | -0.59 |
| Group 3 - PT20 1600 mg Tid | -1.29 |
| Group 4 - PT20 3200 mg Tid | -1.363 |
| Group 5 - Placebo Tid | -0.165 |
Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. (NCT02151643)
Timeframe: Day 1 to Day 29
| Intervention | ng/mL (Mean) |
|---|
| Group 1 - PT20 400 mg Tid | 50 |
| Group 2 - PT20 800 mg Tid | 48.8 |
| Group 3 - PT20 1600 mg Tid | 10.1 |
| Group 4 - PT20 3200 mg Tid | 69.9 |
| Group 5 - Placebo Tid | -67.0 |
Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. (NCT02151643)
Timeframe: Day 1 to Day 29
| Intervention | g/dL (Mean) |
|---|
| Group 1 - PT20 400 mg Tid | 0.02 |
| Group 2 - PT20 800 mg Tid | -0.25 |
| Group 3 - PT20 1600 mg Tid | -0.22 |
| Group 4 - PT20 3200 mg Tid | 0.18 |
| Group 5 - Placebo Tid | -0.13 |
Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms. (NCT02151643)
Timeframe: Day 1 to Day 29
| Intervention | score on a scale (Mean) |
|---|
| Group 1 - PT20 400 mg Tid | -0.9 |
| Group 2 - PT20 800 mg Tid | 2.8 |
| Group 3 - PT20 1600 mg Tid | 0.4 |
| Group 4 - PT20 3200 mg Tid | 1.6 |
| Group 5 - Placebo Tid | 0.1 |
Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)
Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3-5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2). (NCT02151643)
Timeframe: Day 1 to Day 29
| Intervention | mg^2/dL^2 (Mean) |
|---|
| Group 1 - PT20 400 mg Tid | -5.515 |
| Group 2 - PT20 800 mg Tid | -4.035 |
| Group 3 - PT20 1600 mg Tid | -11.127 |
| Group 4 - PT20 3200 mg Tid | -10.996 |
| Group 5 - Placebo Tid | -0.778 |
Change in Plasma NT-pro BNP
To determine the impact of oral Fe repletion on Plasma N-terminal pro-B-type natriuretic peptide (NT-pro BNP) (NCT02188784)
Timeframe: Measured at Baseline and Week 16
| Intervention | pg/ml (Mean) |
|---|
| Polysaccharide Iron Complex 150 mg | 119.36 |
| Placebo (for Polysaccharide Iron Complex 150 mg) | -70.88 |
Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption)
To determine if oral Fe (Iron) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks. (NCT02188784)
Timeframe: Baseline (BL) and Week 16
| Intervention | mL/min (Mean) |
|---|
| Polysaccharide Iron Complex 150 mg | 28.04 |
| Placebo (for Polysaccharide Iron Complex 150 mg) | 3.90 |
Change From Baseline in Ventilatory Efficiency Defined by Ve/VCO2
Change from baseline in Ventilatory Efficiency defined by Ve/VCO2 (carbon dioxide output) as measured by CPET (NCT02188784)
Timeframe: Measured at BL week 16
| Intervention | VE/VCO2 Slope (Mean) |
|---|
| Polysaccharide Iron Complex 150 mg | -0.48 |
| Placebo (for Polysaccharide Iron Complex 150 mg) | -1.31 |
Change From Baseline in O2 Uptake Kinetics as Assessed by Mean Response Time From CPET
To determine the impact of oral Fe repletion on O2 Uptake Kinetics as measured by CPET (NCT02188784)
Timeframe: Measured at BL week 16
| Intervention | seconds (Mean) |
|---|
| Polysaccharide Iron Complex 150 mg | 2.63 |
| Placebo (for Polysaccharide Iron Complex 150 mg) | -0.95 |
Change in Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical Summary Score
"To determine the impact of oral Fe repletion on Health Status: KCCQ.~KCCQ is a 23-item, self administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQs questions are used to calculate scores in ten domains. Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall summary: a combined measure of all the above.~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status." (NCT02188784)
Timeframe: Measured at Baseline, Week 8 and Week 16
| Intervention | units on a scale (Mean) |
|---|
| Week 8 | Week 16 |
|---|
| Placebo (for Polysaccharide Iron Complex 150 mg) | 0.58 | 4.11 |
,| Polysaccharide Iron Complex 150 mg | 3.25 | 3.42 |
Change From Baseline in Sub-maximal Exercise Capacity as Assessed by the 6 Minute Walk Test (6MWT)
To determine the impact of oral Fe repletion on Submaximal exercise capacity as measured by 6MWT (NCT02188784)
Timeframe: Measured at BL, week 8 and week 16
| Intervention | meters (Mean) |
|---|
| 8 weeks | 16 weeks |
|---|
| Placebo (for Polysaccharide Iron Complex 150 mg) | 16.63 | 30.94 |
,| Polysaccharide Iron Complex 150 mg | 12.65 | 10.76 |
Hemoglobin Levels at 12-weeks. Marginal Means (95% CI).
Marginal means (95% CI) at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters. Multiple imputation was used to impute n=49 missing values for hemoglobin at endline. (NCT02481375)
Timeframe: 12-weeks of intervention
| Intervention | g/L (Mean) |
|---|
| Multiple Micronutrients With Iron | 123 |
| Multiple Micronutrients Without Iron | 116 |
| Iron Only | 121 |
| Placebo | 116 |
Percentage of Participants With Improvement on Clinical Global Impression Scale
Seven questions ranging from Very Much Improved to Very Much Worse: Participant had to be at least Very Much Improved to be considered as having improved. The CGI scale consisted of one question. (NCT02499354)
Timeframe: Six weeks
| Intervention | percentage of participants (Number) |
|---|
| Oral Iron | 75 |
| IV Iron | 68 |
Change From Baseline in the Restless Legs Syndrome Rating Scale
Change in International Restless Legs Severity Scale (IRLS) score reflecting RLS severity on the scale of 0-40. The higher the negative score the better the outcome (NCT02499354)
Timeframe: Baseline and at 6 weeks after treatment
| Intervention | units on a scale (Mean) |
|---|
| Oral Iron | -14.0000 |
| IV Iron | -9.7353 |
Composite Cardiovascular Adverse Events (AEs)
"Safety~Results show the composite cardiovascular AEs, that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.~The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~The potential cardiovascular AEs included the following:~Death due to any cause~Non-fatal myocardial infarction~Non-fatal stroke~Unstable angina requiring hospitalisation~Congestive heart failure requiring hospitalisation or medical intervention~Arrhythmias~Hypertension~Hypotension~Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs." (NCT02940860)
Timeframe: Baseline, week 1, 2, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 42 |
| Iron Sucrose | 35 |
S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8
"Efficacy~Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8." (NCT02940860)
Timeframe: Week 1 to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 873 |
| Iron Sucrose | 388 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline
| Intervention | miles (Median) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 19.0 |
| Iron Sucrose | 18.0 |
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions." (NCT02940860)
Timeframe: Baseline to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 3 |
| Iron Sucrose | 0 |
Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
"Efficacy~Hb concentration of >12 g/dL at any time from week 1 to week 8.~Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8." (NCT02940860)
Timeframe: Week 1 to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 259 |
| Iron Sucrose | 121 |
Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
"Efficacy~Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8." (NCT02940860)
Timeframe: Week 1 to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 307 |
| Iron Sucrose | 133 |
Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
"Efficacy~Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.~The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.~A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.~Total score was calculated as shown below:~Total score= Sum of individual scores x 13 / Number of items answered" (NCT02940860)
Timeframe: Baseline, week 1, 2, and 8
| Intervention | score on a scale (Mean) |
|---|
| Week 1 | Week 2 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 5.04 | 7.29 | 9.13 |
,| Iron Sucrose | 5.01 | 7.63 | 9.07 |
Change in Hemoglobin (Hb) From Baseline to Week 8
"Efficacy~Evaluate the effect of iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).~Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with NDD-CKD and IDA, when oral iron preparations were ineffective or could not be used, or in whom the Hb measurement at screening in Investigators' opinion were sufficiently low to require rapid repletion of iron stores." (NCT02940860)
Timeframe: Baseline to week 8
| Intervention | g/dL (Least Squares Mean) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 1.22 |
| Iron Sucrose | 1.14 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline
| Intervention | Hours (Median) |
|---|
| Time spent on visit | Total time spent helping on visit |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 2.00 | 2.00 |
,| Iron Sucrose | 2.00 | 2.00 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline
| Intervention | Participants (Count of Participants) |
|---|
| In employment, YES | Took time off work to attend, YES | Assistance by others to attend visit, YES | Others took time off work to attend, YES |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 152 | 70 | 410 | 82 |
,| Iron Sucrose | 57 | 26 | 197 | 40 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline
| Intervention | US dollars ($) (Median) |
|---|
| Cost of public transport/taxi | Cost of parking |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 0.0 | 0.0 |
,| Iron Sucrose | 0.0 | 0.0 |
Health Care Resource Use Questionnaire
"Pharmacoeconomics~Resources used by the health care staff (per administration), measured by the health care resource use questionnaire.~The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group)." (NCT02940860)
Timeframe: Baseline
| Intervention | hours (Median) |
|---|
| Time spent per site staff | Time spent per subject |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 1.17 | 2.58 |
,| Iron Sucrose | 1.00 | 2.33 |
Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8
"Efficacy~Results show Hb responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 1 g/dL from baseline to the week in question was observed (from baseline to week 1, 2, 4, and 8)." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Responder YES week 1 | Responder YES week 2 | Responder YES week 4 | Responder YES week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 200 | 339 | 430 | 474 |
,| Iron Sucrose | 78 | 112 | 174 | 226 |
Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
"Efficacy~Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | percent (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 12.10 | 5.84 | 4.99 | 5.10 |
,| Iron Sucrose | 4.31 | 5.64 | 5.59 | 5.93 |
Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8
"Efficacy~Changes in s-ferritin from baseline to weeks 1, 2, 4, and 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | ng/mL (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 492.4 | 381.2 | 258.4 | 191.3 |
,| Iron Sucrose | 183.9 | 292.4 | 255.4 | 187.9 |
Change in Hb Concentration From Baseline to Week 1, 2, and 4
"Efficacy~Change in Hb concentration from baseline to week 1, 2, and 4." (NCT02940860)
Timeframe: Baseline, week 1, 2, and 4
| Intervention | g/dL (Mean) |
|---|
| Week 1 | Week 2 | Week 4 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 0.44 | 0.77 | 1.08 |
,| Iron Sucrose | 0.21 | 0.50 | 0.90 |
Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8
"Efficacy~Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | μg/dL (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 34.8 | 11.1 | 6.5 | 7.1 |
,| Iron Sucrose | 11.1 | 12.4 | 10.2 | 12.4 |
Time to First Composite Cardiovascular Safety AE
"Safety~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Week (Median) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | NA |
| Iron Sucrose | NA |
Time to Change in Hb Concentration ≥1 g/dL
"Efficacy~Time to change in Hb concentration ≥1 g/dL.~Subjects who showed Hb concentration increase of ≥1 g/dL (from baseline to week 1, 2, 4, and 8).~For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Days (Median) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 56 |
| Iron Sucrose | 56 |
S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
"Safety~Results show the number of participants who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8." (NCT02940860)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 32 |
| Iron Sucrose | 4 |
Composite Cardiovascular Adverse Events (AEs)
"Safety~Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.~The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~The potential cardiovascular AEs included the following:~Death due to any cause~Non-fatal myocardial infarction~Non-fatal stroke~Unstable angina requiring hospitalisation~Congestive heart failure requiring hospitalisation or medical intervention~Arrhythmias~Hypertension~Hypotension~Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs." (NCT02940886)
Timeframe: Baseline, week 1, 2, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 8 |
| Iron Sucrose | 6 |
Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8
"Efficacy~Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8." (NCT02940886)
Timeframe: Week 1 to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 687 |
| Iron Sucrose | 340 |
Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8
"Efficacy~Hb concentration of >12 g/dL at any time from week 1 to week 8.~Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8." (NCT02940886)
Timeframe: Week 1 to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 484 |
| Iron Sucrose | 225 |
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions." (NCT02940886)
Timeframe: Baseline to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 3 |
| Iron Sucrose | 2 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline
| Intervention | miles (Median) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 15.0 |
| Iron Sucrose | 15.0 |
S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8
"Efficacy~Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8." (NCT02940886)
Timeframe: Week 1 to week 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 680 |
| Iron Sucrose | 164 |
S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8
"Safety~Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 38 |
| Iron Sucrose | 11 |
Time to Change in Hb Concentration ≥2 g/dL
"Efficacy~Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8).~For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Days (Median) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 28 |
| Iron Sucrose | 28 |
Time to First Composite Cardiovascular Safety AE
"Safety~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Week (Median) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | NA |
| Iron Sucrose | NA |
Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8
"Efficacy~Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | μg/dL (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 63.2 | 38.8 | 31.2 | 24.2 |
,| Iron Sucrose | 22.4 | 37.0 | 35.1 | 27.6 |
Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8
"Efficacy~Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.~The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.~A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.~Total score was calculated as shown below:~Total score= Sum of individual scores x 13 / Number of items answered" (NCT02940886)
Timeframe: Baseline, week 1, 2, and 8
| Intervention | score on a scale (Mean) |
|---|
| Week 1 | Week 2 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 7.98 | 10.74 | 14.08 |
,| Iron Sucrose | 7.38 | 11.89 | 15.36 |
Change in Hb Concentration From Baseline to Week 1, 2, and 4
"Efficacy~Change in Hb concentration from baseline to week 1, 2, and 4." (NCT02940886)
Timeframe: Baseline, week 1, 2, and 4
| Intervention | g/dL (Mean) |
|---|
| Week 1 | Week 2 | Week 4 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 0.70 | 1.49 | 2.15 |
,| Iron Sucrose | 0.47 | 1.25 | 2.13 |
Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8
"Efficacy~Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8.~TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | percentage of saturation (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 16.68 | 12.33 | 11.63 | 9.01 |
,| Iron Sucrose | 5.84 | 10.58 | 11.08 | 8.87 |
Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8
"Efficacy~Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8)." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | Participants (Count of Participants) |
|---|
| Responder YES week 1 | Responder YES week 2 | Responder YES week 4 | Responder YES week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 51 | 297 | 514 | 606 |
,| Iron Sucrose | 12 | 94 | 250 | 309 |
Health Care Resource Use Questionnaire
"Pharmacoeconomics~Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline
| Intervention | hours (Median) |
|---|
| Time spent per site staff median | Time spent per subject median |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 1.08 | 3.38 |
,| Iron Sucrose | 1.00 | 3.00 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline
| Intervention | US dollars ($) (Median) |
|---|
| Cost of public transport/taxi | Cost of parking |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 5.0 | 0.0 |
,| Iron Sucrose | 5.0 | 0.0 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline
| Intervention | participants (Number) |
|---|
| In employment, YES | Took time off work to attend, YES | Assistance by others to attend visit, YES | Others took time off work to attend, YES |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 529 | 233 | 211 | 64 |
,| Iron Sucrose | 258 | 113 | 111 | 32 |
Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit
"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)." (NCT02940886)
Timeframe: Baseline
| Intervention | Hours (Median) |
|---|
| Time spent on visit | Total time spent helping on visit |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 2.0 | 2.0 |
,| Iron Sucrose | 2.0 | 2.0 |
Change in Hemoglobin (Hb) From Baseline to Week 8
"Efficacy~Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) .~Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores." (NCT02940886)
Timeframe: Baseline to week 8
| Intervention | g/dL (Least Squares Mean) |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 2.49 |
| Iron Sucrose | 2.49 |
Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8
"Efficacy~Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8." (NCT02940886)
Timeframe: Baseline, week 1, 2, 4, and 8
| Intervention | ng/mL (Mean) |
|---|
| Week 1 | Week 2 | Week 4 | Week 8 |
|---|
| Iron Isomaltoside/Ferric Derisomaltose | 373.5 | 211.8 | 98.0 | 49.0 |
,| Iron Sucrose | 105.7 | 169.9 | 109.2 | 58.7 |
Percentage of Fractional Oral Iron Absorption Following Treatment With Daprodustat and rhEPO
Blood samples were collected at indicated time points for analysis of fractional oral iron absorption following treatment with Daprodustat and rhEPO. Adjusted mean and 95 percent (%) confidence interval (CI) has been presented. (NCT03457701)
Timeframe: Up to Day 57
| Intervention | Percentage (%) of iron absorbed (Mean) |
|---|
| Daprodustat | 20.64 |
| rhEPO | 20.62 |
Period 1 and 2: Change From Baseline in Transferrin Following Treatment With Daprodustat or rhEPO
Blood samples were collected from participants for measurement of transferrin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Gram per Liter (g/L) (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.182 | 0.283 | -0.177 | 0.138 |
,| rhEPO | 0.145 | -0.040 | -0.163 | -0.352 |
Periods 1 and 2: Change From Baseline in Erythrocyte Mean Corpuscular Volume Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of erythrocyte mean corpuscular volume at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Femtoliter (fL) (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | -0.8 | -1.5 | 2.8 | 0.3 |
,| rhEPO | -0.5 | -0.8 | -0.3 | -0.8 |
Periods 1 and 2: Change From Baseline in Transferrin Saturation Following Treatment With Daprodustat or rhEPO
Blood samples were collected from participants for measurement of transferrin saturation at indicated time points. Transferrin saturation was measured as a percentage and is the ratio of serum iron and total iron-binding capacity multiplied by 100. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Percentage (%) of transferrin saturation (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | -5.2 | 3.0 | -5.5 | -6.7 |
,| rhEPO | 3.5 | 8.2 | -4.8 | -4.7 |
Periods 1 and 2: Ratio to Baseline (Day 1) in Hepcidin Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of hepcidin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Hepcidin is presented here. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Microgram per liter (ug/L) (Geometric Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.860 | 0.916 | 0.703 | 0.802 |
,| rhEPO | 0.904 | 1.052 | 1.201 | 1.306 |
Periods 1 and 2: Change From Baseline in Soluble Transferrin Receptor Following Treatment of Daprodustat and rhEPO
Blood samples were collected from participants for measurement of soluble transferrin receptor at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Milligrams per liter (mg/L) (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | -0.218 | -0.340 | -0.338 | -0.308 |
,| rhEPO | 0.063 | -0.015 | 0.227 | 0.195 |
Periods 1 and 2: Change From Baseline in Serum Iron Following Treatment With Daprodustat and rhEPO
Blood samples were collected for measurement of serum iron at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Micromoles per liter (umol/L) (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | -1.5 | 2.5 | -1.3 | -2.2 |
,| rhEPO | 1.7 | 3.3 | -3.5 | -3.3 |
Periods 1 and 2: Change From Baseline in Erythrocytes Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of erythrocytes (red blood cells number) at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | 10^12 cells/liter (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.05 | -0.13 | -0.17 | -0.13 |
,| rhEPO | 0.13 | 0.13 | 0.13 | 0.07 |
Periods 1 and 2: Ratio to Baseline in Ferritin Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of ferritin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The summary of log transformed ration to baseline on markers of iron status for Ferritin is presented here. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Microgram per liter (ug/L) (Geometric Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 1.126 | 1.109 | 1.067 | 1.278 |
,| rhEPO | 0.937 | 1.004 | 0.957 | 0.911 |
Periods 1 and 2: Change From Baseline in Erythroferrone Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of erythroferrone at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Microgram per liter (ug/L) (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.135 | 0.075 | 0.063 | 0.032 |
,| rhEPO | -0.062 | -0.090 | -0.068 | -0.110 |
Periods 1 and 2: Change From Baseline in Hematocrit Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of hematocrit at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Proportion of red blood cells in blood (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.002 | -0.017 | -0.006 | -0.010 |
,| rhEPO | 0.011 | 0.009 | 0.009 | 0.002 |
Periods 1 and 2: Change From Baseline in Hemoglobin Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Grams per liter (g/L) (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.7 | -5.0 | -5.3 | -4.3 |
,| rhEPO | 2.8 | 3.5 | 3.7 | 2.3 |
Periods 1 and 2: Change From Baseline in Reticulocyte Hemoglobin Following Treatment of Daprodustat and rhEPO
Blood samples were collected from participants for measurement of reticulocyte hemoglobin at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | Picogram (pg) (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.333 | 0.250 | 0.817 | 1.083 |
,| rhEPO | -0.033 | 0.717 | -0.350 | -0.117 |
Periods 1 and 2: Change From Baseline in Reticulocytes Following Treatment With Daprodustat and rhEPO
Blood samples were collected from participants for measurement of reticulocytes number at indicated time points. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits in the associated treatment period. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. (NCT03457701)
Timeframe: Baseline (Day 1), Day 14 and Day 28 in treatment periods 1 and 2 (each period is of 28 days)
| Intervention | 10^12 cells/liter (Mean) |
|---|
| Period 1, DAY 14 | Period 1, DAY 28 | Period 2, DAY 14 | Period 2, DAY 28 |
|---|
| Daprodustat | 0.001 | 0.004 | 0.004 | 0.020 |
,| rhEPO | 0.002 | -0.004 | -0.005 | -0.010 |
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug*h/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement C |
|---|
| Cohort 2 | 100.2 | 47.7 |
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement A | MT-6548+Iron supplement B |
|---|
| Cohort 1 | 14.5 | 7.76 | 5.96 |
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement A | MT-6548+Iron supplement B |
|---|
| Cohort 1 | 8.23 | 8.06 | 7.28 |
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement C |
|---|
| Cohort 2 | 5.22 | 4.4 |
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement D |
|---|
| Cohort 3 | 5.23 | 5.05 |
Terminal Elimination Half-life (t1/2) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement A | MT-6548+Iron supplement B |
|---|
| Cohort 1 | 5.38 | 5.39 | 4.33 |
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Median) |
|---|
| MT-6548 | MT-6548+Iron supplement C |
|---|
| Cohort 2 | 1.00 | 1.00 |
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Median) |
|---|
| MT-6548 | MT-6548+Iron supplement D |
|---|
| Cohort 3 | 2.00 | 3.00 |
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | /h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement C |
|---|
| Cohort 2 | 0.1356 | 0.1629 |
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug*h/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement D |
|---|
| Cohort 3 | 129.3 | 16.0 |
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement C |
|---|
| Cohort 2 | 6.97 | 5.76 |
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity(AUC0-∞) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug*h/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement A | MT-6548+Iron supplement B |
|---|
| Cohort 1 | 105.3 | 49.2 | 37.2 |
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug*h/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement A | MT-6548+Iron supplement B |
|---|
| Cohort 1 | 100.4 | 47 | 36 |
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Median) |
|---|
| MT-6548 | MT-6548+Iron supplement A | MT-6548+Iron supplement B |
|---|
| Cohort 1 | 3.00 | 3.00 | 4.00 |
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug*h/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement C |
|---|
| Cohort 2 | 96.3 | 46.4 |
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement C |
|---|
| Cohort 2 | 15.5 | 9.37 |
Mean Residence Time From Zero to Infinity (MRT0-∞) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement D |
|---|
| Cohort 3 | 6.56 | 7.21 |
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | /h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement D |
|---|
| Cohort 3 | 0.1354 | 0.1518 |
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | /h (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement A | MT-6548+Iron supplement B |
|---|
| Cohort 1 | 0.1314 | 0.1302 | 0.1647 |
Maximum Plasma Concentration (Cmax) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement D |
|---|
| Cohort 3 | 27.1 | 2.65 |
Area Under the Plasma Concentration-time Curve From Time Zero Until the Last Quantifiable Concentration (AUC0-last) of Unchanged MT-6548
(NCT03645863)
Timeframe: Up to Day 8 (Cohort 1), Up to Day 5 (Cohort 2, 3)
| Intervention | ug*h/mL (Mean) |
|---|
| MT-6548 | MT-6548+Iron supplement D |
|---|
| Cohort 3 | 125 | 14.9 |
Change From Baseline in Percent Transferrin Saturation
Change in average values of iron metabolism parameter percent transferrin saturation during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12
| Intervention | percent transferrin saturation (Mean) |
|---|
| Week 4 | Week 8 | Week 12 |
|---|
| Ferrum Lek | 2.46 | 8.25 | 7.27 |
,| MALTOFER | 4.44 | 5.47 | 8.03 |
Change From Baseline in Ferritin
Change in average values of iron metabolism parameter ferritin during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12
| Intervention | microgram/liter (Mean) |
|---|
| Week 4 | Week 8 | Week 12 |
|---|
| Ferrum Lek | 3.48 | 4.9 | 7.62 |
,| MALTOFER | 7.35 | 4.49 | 6.55 |
Change From Baseline in Transferrin
Change in average values of iron metabolism parameter transferrin during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12
| Intervention | g/L (Mean) |
|---|
| Week 4 | Week 8 | Week 12 |
|---|
| Ferrum Lek | -0.15 | -0.22 | -0.24 |
,| MALTOFER | -0.14 | -0.22 | -0.25 |
Number of Participants With Response to the Therapy
Response to the therapy is determined as an increase in hemoglobin level by 20 g/L and more after 12-weeks of treatment (NCT03993288)
Timeframe: Baseline and Week 12
| Intervention | Participants (Count of Participants) |
|---|
| Ferrum Lek | 59 |
| MALTOFER | 56 |
Change From Baseline in Blood Hemoglobin Level (g/L)
Changes in blood hemoglobin level (g/L) after 12-weeks of iron-deficiency anaemia treatment, a non-inferiority comparison, as compared with the baseline value (screening visit) between Ferrum Lek® and MALTOFER® groups (NCT03993288)
Timeframe: Baseline and Week 12
| Intervention | g/L (Mean) |
|---|
| Ferrum Lek | 18.33 |
| MALTOFER | 18.52 |
Change From Baseline in Serum Iron
Change in average values of iron metabolism parameter serum iron during the treatment period (NCT03993288)
Timeframe: Baseline, Week 4, 8 and 12
| Intervention | micromoles/liter (Mean) |
|---|
| Week 4 | Week 8 | Week 12 |
|---|
| Ferrum Lek | 1.76 | 4.09 | 5.16 |
,| MALTOFER | 3.42 | 4.34 | 6.12 |