ferric maltol: potential use as an oral therapy for iron deficiency anemia [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 169535 |
| MeSH ID | M0171987 |
| Synonym |
|---|
| ferric maltol |
| 33725-54-1 |
| ferric maltol [usan] |
| st10-021 |
| iron, tris(3-hydroxy-2-methyl-4h-pyran-4-onato-o3,o4)- |
| ferric maltol [inn] |
| st10 |
| ferric maltol [usan:inn] |
| unii-ma10qyf1z0 |
| who 9974 |
| iron (iii) maltol |
| ma10qyf1z0 , |
| iron maltol |
| ferric maltol [who-dd] |
| tris[3-(hydroxy-kappao)-2-methyl-4h-pyran-4-onato-kappao4]iron(iii) |
| ferric maltol [orange book] |
| iron, tris(3-(hydroxy-.kappa.o)-2-methyl-4h-pyran-4-onato-.kappa.o4)- |
| ferric maltol [mi] |
| st-10 |
| feraccru (tn) |
| D10833 |
| ferric maltol (usan/inn) |
| DB15598 |
| Q27283748 |
| iron(3+);2-methyl-4-oxopyran-3-olate |
| iron(iii)2-methyl-4-oxo-4h-pyran-3-olate |
| iron(iii) 2-methyl-4-oxo-4h-pyran-3-olate |
| feraccru |
| b03ab10 |
| iron, tris(3-(hydroxy-kappao)-2-methyl-4h-pyran-4-onato-kappao4)- |
| accrufer |
| maltol ferrique |
| maltol ferrico |
| ferricum maltolum |
| tris(3-(hydroxy-kappao)-2-methyl-4h-pyran-4-onato-kappao4)iron(iii) |
| E83926 |
Ferric maltol is a novel ferric iron compound with potential use as an oral therapy for iron deficiency anemia.
| Excerpt | Reference | Relevance |
|---|---|---|
| "Ferric maltol has been used as an oral drug for iron deficiency. " | ( Simultaneous determination of maltol and maltol glucuronide in human plasma and urine by HPLC-MS/MS: Application in clinical study in patients with iron deficiency. Cai, Z; Ding, L; Guo, H; Zhao, S; Zhou, Q, 2023) | 2.35 |
| Excerpt | Reference | Relevance |
|---|---|---|
| " We conclude that iron from ferric maltol, both at low dose and higher, more therapeutic doses, is at least as well absorbed as from ferrous sulphate." | ( Absorption of low and therapeutic doses of ferric maltol, a novel ferric iron compound, in iron deficient subjects using a single dose iron absorption test. Blake, DR; Bloor, JR; Gutteridge, CN; Hider, RC; Kelsey, SM; Newland, AC, 1991) | 0.84 |
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 1 (4.35) | 18.7374 |
| 1990's | 6 (26.09) | 18.2507 |
| 2000's | 1 (4.35) | 29.6817 |
| 2010's | 5 (21.74) | 24.3611 |
| 2020's | 10 (43.48) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.
| This Compound (59.78) All Compounds (24.57) |
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 5 (21.74%) | 5.53% |
| Reviews | 7 (30.43%) | 6.00% |
| Case Studies | 0 (0.00%) | 4.05% |
| Observational | 1 (4.35%) | 0.25% |
| Other | 10 (43.48%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 3b, Randomized, Controlled, Multicentre Study With Oral Ferric Maltol (Feraccru) or Intravenous Iron (Ferric Carboxy Maltose; FCM), for the Treatment of Iron Deficiency Anaemia in Subjects With Inflammatory Bowel Disease [NCT02680756] | Phase 3 | 250 participants (Actual) | Interventional | 2016-01-31 | Completed | ||
| A Phase 1, Open-Label, Randomised, Repeat Dose, Parallel Group Study to Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects Aged 10-17 Years of Age With Iron Deficiency [NCT03181451] | Phase 1 | 37 participants (Actual) | Interventional | 2017-03-14 | Completed | ||
| A Phase IV Study to Explore the Safety of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Heart Failure Carrying Left Ventricular Assist Devices (ORION-LVAD-1) [NCT03774615] | Phase 4 | 11 participants (Actual) | Interventional | 2019-03-18 | Terminated(stopped due to low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame) | ||
| EXPLorative Data Collection for Patient chAracterIzation, treatmeNt Pathways and Outcomes of IRON Preparations [NCT03382275] | 51 participants (Actual) | Observational [Patient Registry] | 2018-01-16 | Completed | |||
| Randomised, Open-label, Active-controlled, Multicentre, Comparative Study to Evaluate the Safety and Efficacy of Ferric Maltol (Iron (III)-Maltol Complex) (ST10) Oral Suspension Compared to Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to [NCT05126901] | Phase 3 | 98 participants (Anticipated) | Interventional | 2021-10-04 | Recruiting | ||
| A Pilot Study to Explore Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients With Heart Failure [NCT05697211] | Phase 4 | 50 participants (Anticipated) | Interventional | 2023-02-21 | Recruiting | ||
| A Randomized, Open-Label, Single Dose, Four-Way Crossover, Phase I Study to Compare the Pharmacokinetics of Ferric Maltol Capsules and Oral Suspension Under Fasted and Fed Conditions in Adult Healthy Volunteers [NCT04626414] | Phase 1 | 32 participants (Anticipated) | Interventional | 2020-09-28 | Recruiting | ||
| An Open Label Randomised Trial to Assess the Efficacy of Post-Operative Ferric Maltol Vs Standard Care for Anaemia Following Colorectal Cancer Surgery [NCT05177484] | Phase 3 | 40 participants (Anticipated) | Interventional | 2022-05-30 | Recruiting | ||
| A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease [NCT02968368] | Phase 3 | 167 participants (Actual) | Interventional | 2016-12-01 | Completed | ||
| A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEG [NCT01340872] | Phase 3 | 128 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
| Predicting Response to Iron Supplementation in Patients With Active Inflammatory Bowel Disease [NCT05456932] | Phase 4 | 90 participants (Anticipated) | Interventional | 2022-08-19 | Recruiting | ||
| A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Crohn's Disease Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS [NCT01352221] | Phase 3 | 128 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
| A Pilot Study to Explore Preliminary Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Pulmonary Hypertension and Iron Deficiency Anemia [NCT03371173] | Phase 3 | 22 participants (Actual) | Interventional | 2018-03-27 | Terminated(stopped due to low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.~The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190." (NCT01340872)
Timeframe: Week 64 - open-label phase
| Intervention | score on a scale (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 180.7 |
| Placebo Switch to Open-label Extension ST10 Treatment | 177.2 |
ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation (NCT01340872)
Timeframe: Baseline to Week 4 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 1.08 |
| Placebo | 0 |
ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation (NCT01340872)
Timeframe: Baseline to Week 8 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 1.79 |
| Placebo | 0.04 |
Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase (NCT01340872)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | μg/dL (Mean) |
|---|---|
| ST10 | 17.3 |
| Placebo | 1.2 |
Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (NCT01340872)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | μg/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 60.4 |
| Placebo Switch to Open-label Extension ST10 Treatment | 36.6 |
Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase (NCT01340872)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | % serum TSAT (Mean) |
|---|---|
| ST10 | 18.0 |
| Placebo | -0.4 |
Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment (NCT01340872)
Timeframe: Baseline to Week 48 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 3.09 |
| Placebo Switch to Open-label Extension ST10 Treatment | 2.0 |
Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (NCT01340872)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | % serum TSAT (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 18.8 |
| Placebo Switch to Open-label Extension ST10 Treatment | 17.7 |
Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate. (NCT01340872)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 2.26 |
| Placebo | 0.01 |
"Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 12 (FAS), end of double-blind phase (in subjects with UC).~The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.~The score is determined by asking the person with UC questions regarding:~bowel frequency at day/night~urgency of defecation~blood in stool~general health~extracolonic manifestations" (NCT01340872)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | score on a scale (Median) |
|---|---|
| ST10 | 0 |
| Placebo | 0 |
"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.~The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190." (NCT01340872)
Timeframe: Week 12 - double-blind phase
| Intervention | score on a scale (Mean) |
|---|---|
| ST10 | 178.3 |
| Placebo | 176.3 |
Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the 'Week 64' visit was outside the visit window of 64 weeks ± 2 days (NCT01340872)
Timeframe: Baseline to Week 64 EOS - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 1.32 |
| Placebo Switch to Open-label Extension ST10 Treatment | 0.52 |
"Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (in participants with UC only).~The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.~The score is determined by asking the person with UC questions regarding:~bowel frequency at day/night~urgency of defecation~blood in stool~general health~extracolonic manifestations" (NCT01340872)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | score on a scale (Median) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 0 |
| Placebo Switch to Open-label Extension ST10 Treatment | 0 |
Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment (NCT01340872)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 3.07 |
| Placebo Switch to Open-label Extension ST10 Treatment | 2.19 |
Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment (NCT01340872)
Timeframe: Baseline to Week 36 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.85 |
| Placebo Switch to Open-label Extension ST10 Treatment | 2.17 |
Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment (NCT01340872)
Timeframe: Baseline to Week 24 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.68 |
| Placebo Switch to Open-label Extension ST10 Treatment | 1.87 |
Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment (NCT01340872)
Timeframe: Baseline to Week 20 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.45 |
| Placebo Switch to Open-label Extension ST10 Treatment | 1.46 |
Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment. (NCT01340872)
Timeframe: Baseline to Week 16 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.34 |
| Placebo Switch to Open-label Extension ST10 Treatment | 1.04 |
ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12 (NCT01340872)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | g/dL (Least Squares Mean) |
|---|---|
| ST10 | 2.23 |
| Placebo | 0.05 |
ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12 (NCT01340872)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | g/dL (Least Squares Mean) |
|---|---|
| ST10 | 2.11 |
| Placebo | -0.03 |
Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment (NCT01352221)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 3.07 |
| Placebo Switch to Open-label Extension ST10 Treatment | 2.19 |
Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment (NCT01352221)
Timeframe: Baseline to Week 48 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 3.09 |
| Placebo Switch to Open-label Extension ST10 Treatment | 2.0 |
Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment (NCT01352221)
Timeframe: Baseline to Week 36 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.85 |
| Placebo Switch to Open-label Extension ST10 Treatment | 2.17 |
Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment (NCT01352221)
Timeframe: Baseline to Week 20 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.45 |
| Placebo Switch to Open-label Extension ST10 Treatment | 1.46 |
ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation (NCT01352221)
Timeframe: Baseline to Week 4 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 1.08 |
| Placebo | 0 |
ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12 (NCT01352221)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 2.23 |
| Placebo | 0.05 |
ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12 (NCT01352221)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 2.11 |
| Placebo | -0.03 |
Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate. (NCT01352221)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 2.26 |
| Placebo | 0.01 |
"Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 64 (FAS), after 12-week double blind phase and 52 weeks open-label ST10 treatment (in participants with CD only).~The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150-220, moderate-severe Crohn's is typically a CDAI 220-450, and severe disease is defined as a CDAI >450." (NCT01352221)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | score on a scale (Median) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | -16.6 |
| Placebo Switch to Open-label Extension ST10 Treatment | -1.0 |
"Change from baseline (randomisation) in Crohn's Disease Activity Index (CDAI) score at Week 12 (FAS), end of double-blind phase (in subjects with CD).~The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150-220, moderate-severe Crohn's is typically a CDAI 220-450, and severe disease is defined as a CDAI >450." (NCT01352221)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | score on a scale (Median) |
|---|---|
| ST10 | -24 |
| Placebo | 12.5 |
Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment. (NCT01352221)
Timeframe: Baseline to Week 16 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.34 |
| Placebo Switch to Open-label Extension ST10 Treatment | 1.04 |
Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment (NCT01352221)
Timeframe: Baseline to Week 24 - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 2.68 |
| Placebo Switch to Open-label Extension ST10 Treatment | 1.87 |
"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.~The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190." (NCT01352221)
Timeframe: Week 64 - open-label phase
| Intervention | score on a scale (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 180.7 |
| Placebo Switch to Open-label Extension ST10 Treatment | 177.2 |
"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.~The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190." (NCT01352221)
Timeframe: Week 12 - double-blind phase
| Intervention | score on a scale (Mean) |
|---|---|
| ST10 | 178.3 |
| Placebo | 176.3 |
Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (NCT01352221)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | percent (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 18.8 |
| Placebo Switch to Open-label Extension ST10 Treatment | 17.7 |
Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase (NCT01352221)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | percent (Mean) |
|---|---|
| ST10 | 18.0 |
| Placebo | -0.4 |
Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (NCT01352221)
Timeframe: Baseline to Week 64 - open-label phase
| Intervention | μg/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 60.4 |
| Placebo Switch to Open-label Extension ST10 Treatment | 36.6 |
Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase (NCT01352221)
Timeframe: Baseline to Week 12 - double-blind phase
| Intervention | μg/dL (Mean) |
|---|---|
| ST10 | 17.3 |
| Placebo | 1.2 |
ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation (NCT01352221)
Timeframe: Baseline to Week 8 - double-blind phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 | 1.79 |
| Placebo | 0.04 |
Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the 'Week 64' visit was outside the visit window of 64 weeks ± 2 days (NCT01352221)
Timeframe: Baseline to Week 64 EOS - open-label phase
| Intervention | g/dL (Mean) |
|---|---|
| ST10 - Open-label Continuation From Active Arm in Double-blind | 1.32 |
| Placebo Switch to Open-label Extension ST10 Treatment | 0.52 |
Number of Patients with Treatment-emergent Serious Adverse Events (SAEs). (NCT02680756)
Timeframe: Baseline to Week 52
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Iron Compound | 9 |
| Intravenous Iron | 3 |
Change in hemoglobin concentration from baseline to Week 12. (NCT02680756)
Timeframe: Baseline to Week 12
| Intervention | g/dL (Mean) |
|---|---|
| Oral Ferric Iron Compound | 2.45 |
| Intravenous Iron | 3.04 |
Number of Patients with Treatment-emergent Adverse Events (AEs). (NCT02680756)
Timeframe: Baseline to Week 52
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Iron Compound | 75 |
| Intravenous Iron | 43 |
Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin <9.5 g/dL. (NCT02680756)
Timeframe: Baseline to Week 4
| Intervention | g/dl (Mean) |
|---|---|
| Oral Ferric Iron Compound | 1.35 |
| Intravenous Iron | 2.99 |
Change in hemoglobin concentration from baseline to Week 4. (NCT02680756)
Timeframe: Baseline to Week 4
| Intervention | g/dL (Mean) |
|---|---|
| Oral Ferric Iron Compound | 1.27 |
| Intravenous Iron | 2.19 |
Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin <9.5 g/dL. (NCT02680756)
Timeframe: Baseline to Week 12
| Intervention | g/dL (Mean) |
|---|---|
| Oral Ferric Iron Compound | 2.83 |
| Intravenous Iron | 4.18 |
"A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research & general population surveys.~The SF-36 includes one multi-item scale that assesses 8 health components:~Physical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; & General Health Component.~These 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score & the Physical Component Score where higher values mean a better outcome.~Both scales range from 0 to 100, where higher scores indicate better health status.~The survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language." (NCT02680756)
Timeframe: Baseline to Week 52 (LOCF)
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Physical component score | Mental component score | |
| Intravenous Iron | 2.5 | 2.6 |
| Oral Ferric Iron Compound | 3.0 | 3.3 |
Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 months and 12 months (normal limit definition: >=12g/dL women, >=13g/dL men) (NCT02680756)
Timeframe: Baseline to Month 6
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| week 2472536380 | week 2472536381 | week 5272536380 | week 5272536381 | |||||
| Non-anaemic | Anaemic | |||||||
| Oral Ferric Iron Compound | 52 | |||||||
| Intravenous Iron | 58 | |||||||
| Oral Ferric Iron Compound | 28 | |||||||
| Intravenous Iron | 27 | |||||||
| Oral Ferric Iron Compound | 37 | |||||||
| Intravenous Iron | 36 | |||||||
| Oral Ferric Iron Compound | 24 | |||||||
| Intravenous Iron | 20 | |||||||
Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16 (NCT02968368)
Timeframe: 16 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Maltol | 22 |
| Oral Placebo | 5 |
Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16 (NCT02968368)
Timeframe: 16 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Maltol | 7 |
| Oral Placebo | 0 |
Change in hemoglobin concentration from baseline to Week 16. (NCT02968368)
Timeframe: 16 weeks
| Intervention | g/dl (Least Squares Mean) |
|---|---|
| Oral Ferric Maltol | 0.50 |
| Oral Placebo | -0.02 |
Change in Hemoglobin concentration from baseline to Week 8 (NCT02968368)
Timeframe: 8 weeks
| Intervention | g/dl (Mean) |
|---|---|
| Oral Ferric Maltol | 0.53 |
| Oral Placebo | 0.00 |
Changes in iron parameter - ferritin - from baseline to week 16 (NCT02968368)
Timeframe: baseline to week 16
| Intervention | ug/l (Least Squares Mean) |
|---|---|
| Oral Ferric Maltol | 33.13 |
| Oral Placebo | -5.90 |
Changes in iron parameters - serum iron - from baseline to week 16 (NCT02968368)
Timeframe: from baseline to week 16
| Intervention | umol/l (Least Squares Mean) |
|---|---|
| Oral Ferric Maltol | 1.87 |
| Oral Placebo | 0.01 |
Changes in iron parameters - TSAT - from baseline to week 16 (NCT02968368)
Timeframe: baseline to week 16
| Intervention | TSAT (%) (Least Squares Mean) |
|---|---|
| Oral Ferric Maltol | 4.32 |
| Oral Placebo | -0.15 |
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (NCT02968368)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Maltol | 75 |
| Oral Placebo | 42 |
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase (NCT02968368)
Timeframe: Week 52
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Maltol | 76 |
| Oral Placebo | 35 |
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase (NCT02968368)
Timeframe: Week 16
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Maltol | 23 |
| Oral Placebo | 12 |
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase (NCT02968368)
Timeframe: Week 52
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Maltol | 27 |
| Oral Placebo | 9 |
Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16 (NCT02968368)
Timeframe: 16 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| Oral Ferric Maltol | 30 |
| Oral Placebo | 7 |
Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 1 (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | L/h (Mean) |
|---|---|
| 30 mg Ferric Maltol | 1.321 |
| 16.6 mg Ferric Maltol | 0.654 |
| 7.8 mg Ferric Maltol | 0.324 |
Descriptive statistics and population PK analysis of serum iron CL/F from PK samples collected on Day 10 (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | L/h (Mean) |
|---|---|
| 30 mg Ferric Maltol | 3.264 |
| 16.6 mg Ferric Maltol | 1.757 |
| 7.8 mg Ferric Maltol | 0.808 |
Change calculated as difference in values measured at Day 1, predose and on Day 10, predose (NCT03181451)
Timeframe: Pre-dose on Day 1 to Day 10 (0h each day)
| Intervention | umol/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | -2.10 |
| 16.6 mg Ferric Maltol | -2.33 |
| 7.8 mg Ferric Maltol | -4.49 |
Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h (Median) |
|---|---|
| 30 mg Ferric Maltol | 0.75 |
| 16.6 mg Ferric Maltol | 0.75 |
| 7.8 mg Ferric Maltol | 0.75 |
Descriptive summary of TESAE according to MedDRA preferred Term (NCT03181451)
Timeframe: From first dose of ferric maltol Day 1 through study completions, on average 4 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 7.8 mg Ferric Maltol | 0 |
| 16.6 mg Ferric Maltol | 0 |
| 30 mg Ferric Maltol | 0 |
Descriptive summary of incidence and causal relationship of treatment-emergent adverse events leading to discontinuation of study drug/PK assessments according to MedDRA preferred term (PT) and system organ class (SOC) (NCT03181451)
Timeframe: From first dose of Ferric Maltol on Day 1 through study completion, on average 4 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 30 mg Ferric Maltol | 0 |
| 16.6 mg Ferric Maltol | 1 |
| 7.8 mg Ferric Maltol | 0 |
Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Measured after first dose of Ferric Maltol on Day 10. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h).
| Intervention | hour (Median) |
|---|---|
| 7.8 mg Ferric Maltol | 3.00 |
| 16.6 mg Ferric Maltol | 3.00 |
| 30 mg Ferric Maltol | 3.00 |
Transferrin Saturation (TSAT%) Day 1, time to maximum response Tmax (h). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Measured after first dose of Ferric Maltol on Day 1. (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | hour (Median) |
|---|---|
| 7.8 mg Ferric Maltol | 4.00 |
| 16.6 mg Ferric Maltol | 3.00 |
| 30 mg Ferric Maltol | 3.00 |
Transferrin Saturation (TSAT%) Day 10, maximum response (%). Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | percentage saturation (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 27.779 |
| 16.6 mg Ferric Maltol | 27.214 |
| 30 mg Ferric Maltol | 33.524 |
Transferrin Saturation (TSAT%) Day 1, maximum response (%) (NCT03181451)
Timeframe: Measured after first dose of Ferric Maltol on Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | percentage saturation (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 18.68 |
| 16.6 mg Ferric Maltol | 28.261 |
| 30 mg Ferric Maltol | 32.845 |
Transferrin Saturation (TSAT%) Day 1, baseline (NCT03181451)
Timeframe: Measured after first dose of Ferric Maltol on Day 1 (0h)
| Intervention | percentage saturation (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 11.5 |
| 16.6 mg Ferric Maltol | 16.8 |
| 30 mg Ferric Maltol | 15.8 |
Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose (NCT03181451)
Timeframe: Day 1 pre-dose to Day 10 pre-dose (0h on each day)
| Intervention | g/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | -0.085 |
| 16.6 mg Ferric Maltol | -0.147 |
| 7.8 mg Ferric Maltol | 0.032 |
Change calculated as difference in values measured at Day 1, predose and on Day 10, predose (NCT03181451)
Timeframe: Predose from Day 1 to Day 10 (0h on each day)
| Intervention | umol/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | -2.12 |
| 16.6 mg Ferric Maltol | -3.11 |
| 7.8 mg Ferric Maltol | 1.13 |
Descriptive statistics and population PK analysis of maltol glucuronide Tmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h (Median) |
|---|---|
| 30 mg Ferric Maltol | 1.00 |
| 16.6 mg Ferric Maltol | 1.00 |
| 7.8 mg Ferric Maltol | 1.00 |
Maximum serum concentration of serum iron on Day 10. (NCT03181451)
Timeframe: Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 1.0338 |
| 16.6 mg Ferric Maltol | 1.0462 |
| 30 mg Ferric Maltol | 1.3034 |
Maximum serum concentration of serum iron on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 0.7030 |
| 16.6 mg Ferric Maltol | 1.681 |
| 30 mg Ferric Maltol | 1.2328 |
Serum Iron - RAUC(0-6h) Day 10/Day 1 (NCT03181451)
Timeframe: Measured after first and last dose of Ferric Maltol on Day 1 & Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | Ratio (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 1.529 |
| 16.6 mg Ferric Maltol | 1.020 |
| 30 mg Ferric Maltol | 1.038 |
Descriptive statistics of ratio maltol glucuronide Cmax Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | ratio (Mean) |
|---|---|
| 30 mg Ferric Maltol | 1.956 |
| 16.6 mg Ferric Maltol | 1.836 |
| 7.8 mg Ferric Maltol | 1.875 |
Descriptive statistics of ratio maltol glucuronide AUC Day 10/Day 10 from PK samples collected on Day 1 and Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 and Day 10, pre-dose and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | ratio (Mean) |
|---|---|
| 30 mg Ferric Maltol | 2.030 |
| 16.6 mg Ferric Maltol | 1.899 |
| 7.8 mg Ferric Maltol | 1.942 |
Ratio AUC0-6h measured after last dose of Ferric Maltol on Day 10 vs first dose Day 1. (NCT03181451)
Timeframe: Day 1 to Day 10 (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | Ratio (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 1.942 |
| 16.6 mg Ferric Maltol | 1.899 |
| 30 mg Ferric Maltol | 2.030 |
Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h*% (Mean) |
|---|---|
| 30 mg Ferric Maltol | 180.14 |
| 16.6 mg Ferric Maltol | 149.40 |
| 7.8 mg Ferric Maltol | 157.43 |
Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of TSAT from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h*% (Mean) |
|---|---|
| 30 mg Ferric Maltol | 179.47 |
| 16.6 mg Ferric Maltol | 159.21 |
| 7.8 mg Ferric Maltol | 104.50 |
Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h*mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 7.000 |
| 16.6 mg Ferric Maltol | 5.734 |
| 7.8 mg Ferric Maltol | 5.849 |
Descriptive statistics and population PK analysis of pre-dose adjusted incremental AUC(0-6h) of serum iron from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h*mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 6.711 |
| 16.6 mg Ferric Maltol | 5.963 |
| 7.8 mg Ferric Maltol | 3.928 |
Minimum concentration between dose time and dose time+TAU (NCT03181451)
Timeframe: Day 10 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 0.4804 |
| 16.6 mg Ferric Maltol | 0.9762 |
| 30 mg Ferric Maltol | 1.8496 |
Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 4.2355 |
| 16.6 mg Ferric Maltol | 2.1028 |
| 7.8 mg Ferric Maltol | 0.9926 |
Descriptive statistics and population PK analysis of maltol glucuronide Cmax from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 2.4518 |
| 16.6 mg Ferric Maltol | 1.1632 |
| 7.8 mg Ferric Maltol | 0.5299 |
Descriptive statistics and population PK analysis of maltol glucuronide t1/2 from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h (Mean) |
|---|---|
| 30 mg Ferric Maltol | 11.384 |
| 16.6 mg Ferric Maltol | 10.447 |
| 7.8 mg Ferric Maltol | 10.806 |
Change calculated as difference in values measured at Day 1, predose (Baseline) and on Day 10, predose. (NCT03181451)
Timeframe: Pre-dose on Day 1 to Day 10 (0h)
| Intervention | μg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 7.3 |
| 16.6 mg Ferric Maltol | 4.1 |
| 7.8 mg Ferric Maltol | 0.5 |
Descriptive statistics and population PK analysis of maltol AUC from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h*mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 20.511 |
| 16.6 mg Ferric Maltol | 10.518 |
| 7.8 mg Ferric Maltol | 5.016 |
Change from pre-dose to last PK samples collected on Day 10 for maltol glucuronide.Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-dose to last (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 0.4804 |
| 16.6 mg Ferric Maltol | 0.9762 |
| 30 mg Ferric Maltol | 1.8496 |
Number of subjects with concomitant medications Taken by >5% of Subjects (NCT03181451)
Timeframe: Screening, Day 1, Day 10 and Post-Study Follow-up visit, on average 4 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| 30 mg Ferric Maltol | 8 |
| 16.6 mg Ferric Maltol | 13 |
| 7.8 mg Ferric Maltol | 10 |
Descriptive statistics and population PK analysis of change in serum iron [Ctrough to Cmax] from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 0.5486 |
| 16.6 mg Ferric Maltol | 0.3625 |
| 7.8 mg Ferric Maltol | 0.2251 |
Descriptive statistics and population PK analysis of change in serum iron [Ctrough to Cmax] from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 0.6159 |
| 16.6 mg Ferric Maltol | 0.4102 |
| 7.8 mg Ferric Maltol | 0.21715 |
Change calculated as difference in values measured at Screening (Baseline) and on Day 10 (NCT03181451)
Timeframe: Screening and Day 10 (1-4 hours post-dose)
| Intervention | g/dL (Mean) |
|---|---|
| 30 mg Ferric Maltol | -0.03 |
| 16.6 mg Ferric Maltol | -0.33 |
| 7.8 mg Ferric Maltol | -0.45 |
Change from Baseline to Day 10 in Absolute Reticulocyte Count collected from PK samples (NCT03181451)
Timeframe: Change calculated as difference in values measured at Screening (Baseline) and on Day 10.
| Intervention | cells*10^12/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 0.036 |
| 16.6 mg Ferric Maltol | -0.001 |
| 7.8 mg Ferric Maltol | 0.016 |
Descriptive statistics and population PK analysis of iron Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 1.1667 |
| 16.6 mg Ferric Maltol | 0.9557 |
| 7.8 mg Ferric Maltol | 0.9748 |
Descriptive statistics and population PK analysis of maltol glucuronide Cave(0-6h) from PK samples collected on Day 10. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 10 pre-final dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 3.4186 |
| 16.6 mg Ferric Maltol | 1.7531 |
| 7.8 mg Ferric Maltol | 0.8360 |
AUC0-tau for Maltol Glucuronide from PK samples collected on Day 10. Area under the plasma concentration versus time curve from time 0 to tau. (NCT03181451)
Timeframe: Measured after last dose of Ferric Maltol on Day 10. (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h mg/L (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 8.59 |
| 16.6 mg Ferric Maltol | 17.862 |
| 30 mg Ferric Maltol | 34.368 |
AUC0-inf for Maltol Glucuronide from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Measured after first dose of Ferric Maltol on Day 1 (0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h.mg/L (Mean) |
|---|---|
| 7.8 mg Ferric Maltol | 8.590 |
| 16.6 mg Ferric Maltol | 17.862 |
| 30 mg Ferric Maltol | 34.372 |
Descriptive statistics and population PK analysis of maltol glucuronide AUC from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | h*mg/L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 11.090 |
| 16.6 mg Ferric Maltol | 5.613 |
| 7.8 mg Ferric Maltol | 2.585 |
Descriptive statistics and population PK analysis of iron V/F from PK samples collected on Day 1. Each subject had 1 pre-dose (0h) and 2 post dose PK blood sampling between (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h). Subjects were assigned to PK blood sampling schedule. For each individual subject the PK blood sampling schedule was the same on Day 1 and Day 10. (NCT03181451)
Timeframe: Day 1 pre-first dose of Ferric Maltol and up to 6 hours post-dose (0h, 0.5-1h, 1-2h, 2-3h, 3-4h, 4-6h)
| Intervention | L (Mean) |
|---|---|
| 30 mg Ferric Maltol | 22.114 |
| 16.6 mg Ferric Maltol | 14.244 |
| 7.8 mg Ferric Maltol | 10.462 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| maltol maltol: found in bark of young larch trees; isolated from Passiflora incarnata; possesses depressant properties in mice; potentiates hexobarbital-induced narcosis & inhibits spontaneous motor activity; structure | 8.86 | 3 | 0 | 4-pyranones | metabolite |
| nitrilotriacetic acid Nitrilotriacetic Acid: A derivative of acetic acid, N(CH2COOH)3. It is a complexing (sequestering) agent that forms stable complexes with Zn2+. (From Miall's Dictionary of Chemistry, 5th ed.) | 6.97 | 1 | 0 | NTA; tricarboxylic acid | carcinogenic agent; nephrotoxic agent |
| ferrous sulfate ferrous sulfate: Ferro-Gradumet is ferrous sulfate in controlled release form; RN given refers to Fe(+2)[1:1] salt. iron(2+) sulfate (anhydrous) : A compound of iron and sulfate in which the ratio of iron(2+) to sulfate ions is 1:1. Various hydrates occur naturally - most commonly the heptahydrate, which loses water to form the tetrahydrate at 57degreeC and the monohydrate at 65degreeC. | 5.59 | 5 | 1 | iron molecular entity; metal sulfate | reducing agent |
| ferric nitrilotriacetate ferric nitrilotriacetate: induces diabetes in animals (iron loading) | 1.97 | 1 | 0 | iron chelate | carcinogenic agent; mutagen |
| phenyl acetate phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid. | 1.97 | 1 | 0 | benzenes; phenyl acetates | |
| ferric citrate ferric citrate: RN given refers to Fe(+3)[1:1] salt. iron(III) citrate : An iron chelate resulting from the combination of iron(3+) and citrate(3-). | 3.31 | 1 | 0 | iron chelate | anti-anaemic agent; nutraceutical |
| fumarates Fumarates: Compounds based on fumaric acid.. fumarate(2-) : A C4-dicarboxylate that is the E-isomer of but-2-enedioate(2-) | 3.41 | 1 | 0 | butenedioate; C4-dicarboxylate | human metabolite; metabolite; Saccharomyces cerevisiae metabolite |
| acebutolol alpha-D-glucosyl-(1->4)-alpha-D-mannose : An alpha-D-glucosyl-(1->4)-D-mannopyranose in which the anomeric hydroxy group has alpha configuration. | 6.03 | 3 | 1 | alpha-D-glucosyl-(1->4)-D-mannopyranose | |
| losartan potassium Erythropoietin: Glycoprotein hormone, secreted chiefly by the KIDNEY in the adult and the LIVER in the FETUS, that acts on erythroid stem cells of the BONE MARROW to stimulate proliferation and differentiation. | 3.41 | 1 | 0 | ||
| nad NAD(1-) : An anionic form of nicotinamide adenine dinucleotide arising from deprotonation of the two OH groups of the diphosphate moiety. | 1.97 | 1 | 0 | organophosphate oxoanion | cofactor; human metabolite; hydrogen acceptor; Saccharomyces cerevisiae metabolite |
| ascorbic acid Ascorbic Acid: A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.. L-ascorbic acid : The L-enantiomer of ascorbic acid and conjugate acid of L-ascorbate.. L-ascorbate : The L-enantiomer of ascorbate and conjugate base of L-ascorbic acid, arising from selective deprotonation of the 3-hydroxy group. Required for a range of essential metabolic reactions in all animals and plants.. vitamin C : Any member of a group of vitamers that belong to the chemical structural class called butenolides that exhibit biological activity against vitamin C deficiency in animals. The vitamers include L-ascorbic acid and its salt, ionized and oxidized forms. | 1.97 | 1 | 0 | ascorbic acid; vitamin C | coenzyme; cofactor; flour treatment agent; food antioxidant; food colour retention agent; geroprotector; plant metabolite; skin lightening agent |
| teferrol [no description available] | 3.41 | 1 | 0 | ||
| ferric oxide, saccharated Ferric Oxide, Saccharated: A glucaric acid-iron conjugate that is used in the treatment of IRON-DEFICIENCY ANEMIA, including in patients with chronic kidney disease, when oral iron therapy is ineffective or impractical. | 3.41 | 1 | 0 | ||
| ferric carboxymaltose ferric carboxymaltose: effective for treatment of postpartum anemia | 11.03 | 3 | 1 |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Anemias, Iron-Deficiency [description not available] | 0 | 13.84 | 23 | 15 |
| Chronic Kidney Diseases [description not available] | 0 | 6.65 | 3 | 1 |
| Anemia, Iron-Deficiency Anemia characterized by decreased or absent iron stores, low serum iron concentration, low transferrin saturation, and low hemoglobin concentration or hematocrit value. The erythrocytes are hypochromic and microcytic and the iron binding capacity is increased. | 0 | 13.84 | 23 | 15 |
| Renal Insufficiency, Chronic Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002) | 0 | 6.65 | 3 | 1 |
| Lassitude [description not available] | 0 | 3.17 | 1 | 0 |
| Bowel Diseases, Inflammatory [description not available] | 0 | 10.54 | 10 | 5 |
| Fatigue The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli. | 0 | 3.17 | 1 | 0 |
| Inflammatory Bowel Diseases Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS. | 0 | 10.54 | 10 | 5 |
| Pulmonary Hypertension [description not available] | 0 | 8.17 | 1 | 0 |
| Hypertension, Pulmonary Increased VASCULAR RESISTANCE in the PULMONARY CIRCULATION, usually secondary to HEART DISEASES or LUNG DISEASES. | 0 | 3.17 | 1 | 0 |
| Colitis Gravis [description not available] | 0 | 11.76 | 14 | 13 |
| Colitis, Granulomatous [description not available] | 0 | 11.76 | 14 | 13 |
| Colitis, Ulcerative Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN. | 0 | 11.76 | 14 | 13 |
| Crohn Disease A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients. | 0 | 11.76 | 14 | 13 |
| Body Weight The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms. | 0 | 2.31 | 1 | 0 |
| Colitis Inflammation of the COLON section of the large intestine (INTESTINE, LARGE), usually with symptoms such as DIARRHEA (often with blood and mucus), ABDOMINAL PAIN, and FEVER. | 0 | 2.31 | 1 | 0 |
| Innate Inflammatory Response [description not available] | 0 | 3.06 | 1 | 0 |
| Anemia A reduction in the number of circulating ERYTHROCYTES or in the quantity of HEMOGLOBIN. | 0 | 3.06 | 1 | 0 |
| Inflammation A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function. | 0 | 3.06 | 1 | 0 |
| Anemia, Hypochromic Anemia characterized by a decrease in the ratio of the weight of hemoglobin to the volume of the erythrocyte, i.e., the mean corpuscular hemoglobin concentration is less than normal. The individual cells contain less hemoglobin than they could have under optimal conditions. Hypochromic anemia may be caused by iron deficiency from a low iron intake, diminished iron absorption, or excessive iron loss. It can also be caused by infections or other diseases, therapeutic drugs, lead poisoning, and other conditions. (Stedman, 25th ed; from Miale, Laboratory Medicine: Hematology, 6th ed, p393) | 0 | 4.05 | 3 | 1 |