Page last updated: 2024-11-05

calcium acetate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Occurs in Manufacturing Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

calcium acetate: a principal compound used as phosphate binders in patients with chronic renal failure; used like sevelamer [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

calcium acetate : The calcium salt of acetic acid. It is used, commonly as a hydrate, to treat hyperphosphataemia (excess phosphate in the blood) in patients with kidney disease: the calcium ion combines with dietary phosphate to form (insoluble) calcium phosphate, which is excreted in the faeces. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID6116
CHEMBL ID1200800
CHEBI ID3310
SCHEMBL ID23872
MeSH IDM0331741

Synonyms (87)

Synonym
ca(oac)2
chebi:3310 ,
acetic acid, calcium salt
brown acetate
teltozan
gray acetate of lime
lime pyrolignite
calcium di(acetate)
acetate of lime
sorbo-calcion
phoslo
gray acetate
ai3-02903
fema no. 2228
hsdb 928
calcium diacetate
lime acetate
brown acetate of lime
einecs 200-540-9
calcium acetate
ccris 4921
calcium ethanoate
DB00258
calcium(ii) acetate
phoslo (tn)
D00931
calcium acetate (usp)
62-54-4
calcarea acetica
acetic acid, calcium salt (2:1)
ins no.263
CHEMBL1200800
calcium acetate, anhydrous
e263
calcium acetate anhydrous
ins-263
e-263
calcium acetate [usp:jan]
phoslo gelcaps
phoslyra
unii-y882yxf34x
y882yxf34x ,
ec 200-540-9
sanopan
FT-0623377
FT-0623376
AKOS015904560
calcium acetate [who-dd]
calcium acetate [vandf]
calcium acetate [mart.]
calcium acetate [orange book]
calcium acetate [fcc]
calcium acetate [inci]
calcium acetate [mi]
calcium acetate [ep monograph]
calcium acetate [fhfi]
calcium acetate [ii]
calcarea acetica [hpus]
eliphos
calcium acetate [usp-rs]
calcium acetate, anhydrous [ep impurity]
calcium acetate [hsdb]
calcium acetate [usp monograph]
VSGNNIFQASZAOI-UHFFFAOYSA-L
calcium acetate salt
SCHEMBL23872
DTXSID0020234 ,
J-519530
acetic acid calcium salt
Q409251
AMY23411
calcium;diacetate
cis,cis-1,3,5-cyclohexanetricarboxylicacid
calcium acetate, anhydrous (ep impurity)
calcium acetate (usp-rs)
calcio acetato
calcium acetate capsules 667 mg
mineral supplement containing calcium acetate
calcium acetate (mart.)
calphron
calcium acetate (ep monograph)
calcium acetate 667 mg
calcium acetate (ii)
dtxcid00234
calcium acetate (usp monograph)
62-54-4 , anhydride
calcium acetate (usp:jan)

Research Excerpts

Overview

Calcium acetate (CaAc) is an effective phosphate binder in patients with chronic renal failure.

ExcerptReferenceRelevance
"Calcium acetate (CaAc) is an effective phosphate binder in patients with chronic renal failure. "( Efficacy and tolerance of three different calcium acetate formulations in hemodialysis patients.
Böttger, WM; Gelens, MA; Kaufmann, BG; Klaassen, HA; van den Bergh, JP; Verstappen, VM, 1999
)
2.01

Treatment

ExcerptReferenceRelevance
"Treatment with calcium acetate (mean 4.6 +/- 2.1 g/day - equivalent to 1.2 +/- 0.5 g of elemental calcium) led to a significant increase in EBT-determined calcification of the coronary arteries (mean change 182 +/- 350, median change +20, p = 0.002) and aorta (mean change 181 +/- 855, median change +73, p < 0.0001)."( The effects of sevelamer and calcium acetate on proxies of atherosclerotic and arteriosclerotic vascular disease in hemodialysis patients.
Boulay, A; Burke, SK; Chertow, GM; Goodman, WG; Kuhlik, A; McCarthy, JT; Raggi, P; Schulman, G; Silberzweig, J; Toto, RD,
)
0.76

Pharmacokinetics

ExcerptReferenceRelevance
" This study in healthy individuals investigated the effect of 2 PBs, sevelamer carbonate and calcium acetate, on the pharmacokinetic properties of a single oral dose of roxadustat administered concomitantly or with a time lag."( Effect of the Phosphate Binders Sevelamer Carbonate and Calcium Acetate on the Pharmacokinetics of Roxadustat After Concomitant or Time-separated Administration in Healthy Individuals.
Barroso-Fernandez, B; den Adel, M; Golor, G; Groenendaal-van de Meent, D; Kerbusch, V; Schaddelee, M; van Dijk, J, 2021
)
1.09

Bioavailability

The relative oral bioavailability of ciprofloxacin is significantly decreased when administered with sevelamer hydrochloride or calcium acetate. The preclinical drug absorption rate was lower with calciumacetate loaded than calcium-free alginate pellets.

ExcerptReferenceRelevance
" The relative bioavailability of iron administered with each phosphate binder compared to iron administered alone was estimated."( Effect of phosphate binders on supplemental iron absorption in healthy subjects.
Bay, WH; Coyle, JD; Hoshaw-Woodard, S; Pruchnicki, MC, 2002
)
0.31
"The oral bioavailability of ciprofloxacin is significantly decreased when administered with calcium carbonate."( Effects of sevelamer hydrochloride and calcium acetate on the oral bioavailability of ciprofloxacin.
Kays, MB; Moe, SM; Mueller, BA; Overholser, BR; Sowinski, KM, 2003
)
0.59
"The relative oral bioavailability of ciprofloxacin is significantly decreased when administered with sevelamer hydrochloride or calcium acetate."( Effects of sevelamer hydrochloride and calcium acetate on the oral bioavailability of ciprofloxacin.
Kays, MB; Moe, SM; Mueller, BA; Overholser, BR; Sowinski, KM, 2003
)
0.79
"The objective was to investigate the bioavailability and mechanism of calcium absorption of calcium ascorbate (ASC) and calcium acetate (AC)."( Calcium bioavailability and kinetics of calcium ascorbate and calcium acetate in rats.
Cai, J; Wastney, ME; Weaver, CM; Zhang, Q, 2004
)
0.77
"While calcium carbonate is known to interfere with the gastrointestinal absorption of levothyroxine, we hypothesized that other phosphate binders would also bind to levothyroxine and decrease bioavailability of levothyroxine in dialysis patients."( Effect of phosphate binders upon TSH and L-thyroxine dose in patients on thyroid replacement.
Carter, TB; Dansby, LM; Diskin, CJ; Radcliff, L; Stokes, TJ, 2007
)
0.34
"Sevelamer (but not calcium acetate) in addition to calcium carbonate appears to interfere with the bioavailability of levothyroxine."( Effect of phosphate binders upon TSH and L-thyroxine dose in patients on thyroid replacement.
Carter, TB; Dansby, LM; Diskin, CJ; Radcliff, L; Stokes, TJ, 2007
)
0.67
" The preclinical drug absorption rate was lower with calcium acetate loaded than calcium-free alginate pellets."( Drug release, preclinical and clinical pharmacokinetics relationships of alginate pellets prepared by melt technology.
Bose, A; Dan, S; Harjoh, N; Pal, TK; Wong, TW, 2016
)
0.68

Dosage Studied

Sevelamer was also found to be associated with significantly higher dosing requirement of thyroid replacement. The purpose of this study is to develop a new preparation of compound effervescent granule of biological calcium acetate.

ExcerptRelevanceReference
" Control of hyperphosphatemia, maintenance of normocalcemia, and appropriate dosing of vitamin D analogues can prevent HPT in many cases."( Current medical management of secondary hyperparathyroidism.
Llach, F; Yudd, M, 2000
)
0.31
" Five different methods for dosing phosphate binders were determined."( The renal dietitian's role in managing hyperphosphatemia and secondary hyperparathyroidism in dialysis patients: a national survey.
Martin, CJ; Reams, SM, 2003
)
0.32
" Friedman Test and Wilcoxon Signed Ranks Test were performed to analyze the significance of difference in thyroxine dosing and TSH levels between the different phosphate binders."( Effect of phosphate binders upon TSH and L-thyroxine dose in patients on thyroid replacement.
Carter, TB; Dansby, LM; Diskin, CJ; Radcliff, L; Stokes, TJ, 2007
)
0.34
" Sevelamer was also found to be associated with significantly higher dosing requirement of thyroid replacement than those on either calcium carbonate or calcium acetate (Z = -3."( Effect of phosphate binders upon TSH and L-thyroxine dose in patients on thyroid replacement.
Carter, TB; Dansby, LM; Diskin, CJ; Radcliff, L; Stokes, TJ, 2007
)
0.54
" Medicare costs for 1895 dosed Medicare-primary-payer participants were evaluated."( Economic evaluation of sevelamer versus calcium-based phosphate binders in hemodialysis patients: a secondary analysis using centers for Medicare & Medicaid services data.
Fan, Q; Liu, J; St Peter, WL; Weinhandl, E, 2009
)
0.35
" The reasons claimed by patients for their negative ratings of PB were the type of dosage form, the taste, the number of tablets and gastric intolerance."( [Phosphorus binders: preferences of patients on haemodialysis and its impact on treatment compliance and phosphorus control].
Álvarez-Ude, F; Arenas, MD; Gil, MT; Malek, T; Moledous, A; Reig-Ferrer, A, 2010
)
0.36
" The purpose of this study is to develop a new preparation of compound effervescent granule of the biological calcium acetate (Ca(CH3COO)2 effervescent granule), overcoming the disadvantages of the previous other dosage forms of calcium and thus enhancing the therapeutic efficacy."( Preparation and Characterization of the Biological Compound Effervescent Granule of Calcium Acetate.
Chen, L; Chen, X; Li, T; Liang, T; Lin, Y; Liu, Z; Luo, Y; Sun, X; Wang, J; Ye, Y; Zhong, Z, 2019
)
0.95
"The biological Ca(CH3COO)2 effervescent granule is a novel dosage form among so many kinds of calcium preparations."( Preparation and Characterization of the Biological Compound Effervescent Granule of Calcium Acetate.
Chen, L; Chen, X; Li, T; Liang, T; Lin, Y; Liu, Z; Luo, Y; Sun, X; Wang, J; Ye, Y; Zhong, Z, 2019
)
0.74
" Results from this study helped inform dosing and administration guidelines aimed at reducing interactions between roxadustat and these PBs."( Effect of the Phosphate Binders Sevelamer Carbonate and Calcium Acetate on the Pharmacokinetics of Roxadustat After Concomitant or Time-separated Administration in Healthy Individuals.
Barroso-Fernandez, B; den Adel, M; Golor, G; Groenendaal-van de Meent, D; Kerbusch, V; Schaddelee, M; van Dijk, J, 2021
)
0.87
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (49 Items)

ItemProcessFrequency
Sweet snackscore-ingredient14
Snackscore-ingredient14
Meat alternativescore-ingredient14
Meat analoguescore-ingredient13
Confectioneriescore-ingredient12
Plant-based foodscore-ingredient11
Plant-based foods and beveragescore-ingredient11
Candiescore-ingredient7
Mycoproteincore-ingredient4
Meats and their productscore-ingredient3
Meatscore-ingredient3
Biscuits and cakescore-ingredient2
Rice puddingscore-ingredient2
Dessertscore-ingredient2
Puddingscore-ingredient2
Pastriescore-ingredient1
Creamscore-ingredient1
Dairiescore-ingredient1
Vegetables based foodscore-ingredient1
Fruits and vegetables based foodscore-ingredient1
Cakescore-ingredient1
Groceriescore-ingredient1
Dipscore-ingredient1
Saucescore-ingredient1
Condimentscore-ingredient1
Chipolatascore-ingredient1
French sausagescore-ingredient1
Sausagescore-ingredient1
Prepared meatscore-ingredient1
Pastiscore-ingredient1
Cornish Pastycore-ingredient1
Plant-based mealscore-ingredient1
Puff pastry mealscore-ingredient1
Pie doughcore-ingredient1
Mealscore-ingredient1
Cereals and their productscore-ingredient1
Cereals and potatoescore-ingredient1
Alcoholic beveragescore-ingredient1
Beveragescore-ingredient1
Frozen plant-based foodscore-ingredient1
Frozen foodscore-ingredient1
Quorncore-ingredient1
Vegan pattiescore-ingredient1
Vegetarian pattiescore-ingredient1
en:Meat analoguescore-ingredient1
en:Meat alternativescore-ingredient1
Alimentos Congeladoscore-ingredient1
Alimentos à base de plantascore-ingredient1
Alimentos e bebidas à base de plantascore-ingredient1

Roles (1)

RoleDescription
chelatorA ligand with two or more separate binding sites that can bind to a single metallic central atom, forming a chelate.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
calcium salt
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (2)

Assay IDTitleYearJournalArticle
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (184)

TimeframeStudies, This Drug (%)All Drugs %
pre-19907 (3.80)18.7374
1990's5 (2.72)18.2507
2000's84 (45.65)29.6817
2010's76 (41.30)24.3611
2020's12 (6.52)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 74.64

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.

MetricThis Compound (vs All)
Research Demand Index74.64 (24.57)
Research Supply Index5.46 (2.92)
Research Growth Index5.38 (4.65)
Search Engine Demand Index138.92 (26.88)
Search Engine Supply Index2.16 (0.95)

This Compound (74.64)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials41 (21.13%)5.53%
Reviews24 (12.37%)6.00%
Case Studies8 (4.12%)4.05%
Observational4 (2.06%)0.25%
Other117 (60.31%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (22)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Changes in Biochemical and Vascular Parameters w/Lanthanum Carbonate & Calcium Acetate Therapy Compared to Dietary Intervention in Pts w/Stage 3 & 4 Chronic Kidney Disease & Abnormal Phosphorus Homeostasis: a Randomized Controlled Trial [NCT01357317]Phase 3120 participants (Anticipated)Interventional2011-06-30Recruiting
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients With Hyperphosphataemia [NCT02688764]Phase 385 participants (Actual)Interventional2016-05-26Terminated(stopped due to The study was prematurely ended due to the modification of study requirements by the US Food and Drug Administration and the European Medicines Agency)
Sevelamer, FGF-23 and Endothelial Dysfunction in CKD [NCT01135615]Phase 4100 participants (Actual)Interventional2008-01-31Completed
Effect of Non-calcium Phosphate Binders Versus Calcium Based Binders on Chronic Kidney Disease -Mineral and Bone Disorder in Children on Regular Hemodialysis [NCT03202407]Phase 340 participants (Anticipated)Interventional2017-08-01Not yet recruiting
The Short-chain Fatty Acid Acetate for Improving Age-associated Arterial Dysfunction [NCT05424263]Phase 266 participants (Anticipated)Interventional2022-09-29Recruiting
Potential Therapeutic Role of Effervescent Calcium-Magnesium Citrate in Chronic Kidney Disease Stage V [NCT03565913]Phase 2/Phase 3245 participants (Anticipated)Interventional2017-01-22Recruiting
Randomized Comparative Open Trial of Occlusive Therapy With a Hydrocolloid or Silicone Versus Conventional Drying Treatment for the Local Care of Acute Lesions Caused by Herpes Zoster. [NCT04258930]36 participants (Anticipated)Interventional2020-02-26Recruiting
Randomized, Controlled, 3-Arm, Open Label, Cross-Over Bioequivalence Study Comparing Liquid PhosLo vs. PhosLo Gelcaps Using Calcium Citrate as a Positive Control in Healthy Volunteers [NCT00742820]Phase 146 participants (Actual)Interventional2008-08-31Completed
A Double Blind Randomized Placebo Controlled Trial of Maintenance of Normal Serum Phosphorus in Chronic Kidney Disease (CKD) [NCT00785629]148 participants (Actual)Interventional2009-02-28Completed
Study of the Effect of the Consumption of Ferric Hydroxide Adipate on Urinary Phosphorus. [NCT01991574]Early Phase 130 participants (Actual)Interventional2009-04-30Completed
A Phase 1, Three-Part, Open-Label Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat [NCT04299633]Phase 154 participants (Actual)Interventional2020-06-15Completed
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia [NCT03824587]Phase 2/Phase 3236 participants (Actual)Interventional2019-02-28Completed
A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects [NCT04485039]Phase 444 participants (Actual)Interventional2022-06-08Completed
[NCT00486772]Phase 40 participants InterventionalCompleted
An Open Label, Randomized, Parallel Design Study to Investigate the Efficacy and Safety of Sevelamer Hydrochloride (Renagel®) Compared With Calcium Acetate in Peritoneal Dialysis Patients [NCT00196755]Phase 3138 participants (Actual)Interventional2004-12-31Completed
Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals [NCT00018135]0 participants InterventionalCompleted
CARE-2 (Calcium Acetate (PhosLo®)/Sevelamer(Renagel®) Evaluation Study 2) [NCT00211939]Phase 4203 participants (Actual)Interventional2005-01-31Completed
EPIC (Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease): A Prospective, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel Arm, Study of PhosLo on Phosphorus Levels in Subjects With Chronic Kidney Disease [NCT00211978]Phase 3110 participants (Actual)Interventional2005-05-31Completed
A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4 [NCT01277497]Phase 430 participants (Actual)Interventional2011-01-31Terminated(stopped due to low enrollment)
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients [NCT01755078]Phase 4166 participants (Actual)Interventional2007-06-30Completed
Randomized,Multi-center,Phase IV, 2-arm,Open-Label,Cross-over Study to Demonstrate the Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients [NCT01427907]Phase 438 participants (Actual)Interventional2011-09-30Completed
Arterial Stiffness and Arterial Calcifications Evolution in ESRD Haemodialysis Patients Treated by Sevelamer or Calcium Acetate [NCT00364000]0 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to Limitted financial resources)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00785629 (1) [back to overview]Serum Phosphorus
NCT01427907 (1) [back to overview]Serum Phosphorus Levels
NCT02688764 (24) [back to overview]Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group
NCT02688764 (24) [back to overview]Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group
NCT02688764 (24) [back to overview]Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups
NCT02688764 (24) [back to overview]Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events
NCT02688764 (24) [back to overview]Number and Percentage of Participants With Any Treatment Emergent Adverse Event
NCT02688764 (24) [back to overview]Participants With Sustained Hypercalcaemia
NCT02688764 (24) [back to overview]25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Change in Serum Phosphorus (SP) Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline
NCT02688764 (24) [back to overview]Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group
NCT02688764 (24) [back to overview]Ferritin Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Iron Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Osteocalcin-CL Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Serum iPTH Levels at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Serum Phosphorus Values at Each Visit
NCT02688764 (24) [back to overview]Serum Total Corrected Calcium at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Transferrin Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline
NCT02688764 (24) [back to overview]Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage
NCT02688764 (24) [back to overview]Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage
NCT03824587 (4) [back to overview]Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.
NCT03824587 (4) [back to overview]Relative Change From Baseline in cFGF23 at Week 4
NCT03824587 (4) [back to overview]Relative Change From Baseline in iFGF23 at Week 4
NCT03824587 (4) [back to overview]s-P Response at Week 4

Serum Phosphorus

mean serum phosphorus from months 3-9 (NCT00785629)
Timeframe: months 3-9

Interventionmg/dL (Mean)
All Active Treated Patients3.9
All Placebo Treated Patients4.2

[back to top]

Serum Phosphorus Levels

The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject (NCT01427907)
Timeframe: 2 weeks

Interventionmg/dL (Mean)
Calcium Acetate Oral Solution4.6
Sevelamer Carbonate4.6

[back to top]

Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group

(NCT02688764)
Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Interventionmmol/L (Least Squares Mean)
PA21 (Velphoro®)-0.120

[back to top]

Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group

(NCT02688764)
Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Interventionmmol/L (Least Squares Mean)
Calcium Acetate (Phoslyra®)-0.615

[back to top]

Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups

(NCT02688764)
Timeframe: From baseline to study completion, up to 34 weeks after treatment start date

Interventionmmol/L (Least Squares Mean)
PA21 (Velphoro®)0.099
Calcium Acetate (Phoslyra®)-0.393

[back to top]

Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events

Any adverse event Leading to Study Drug Withdrawal is considered. (NCT02688764)
Timeframe: through study completion, up to 34 weeks after treatment start date

InterventionParticipants (Count of Participants)
PA21 (Velphoro®)12
Calcium Acetate (Phoslyra®)6

[back to top]

Number and Percentage of Participants With Any Treatment Emergent Adverse Event

"Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participants, in particular, the number of participants with at least one TEAEs until end of stage 2.~Please refer to the detailed tables included on the Adverse Event Module for specifics." (NCT02688764)
Timeframe: through study completion, up to 34 weeks after treatment start date

InterventionParticipants (Count of Participants)
PA21 (Velphoro®)50
Calcium Acetate (Phoslyra®)14

[back to top]

Participants With Sustained Hypercalcaemia

Number and percentages of participants with at least 1 episode of sustained hypercalcaemia (defined as total calcium value above the upper safety limit confirmed by repeat sample 1 week later) during the study (NCT02688764)
Timeframe: through study completion, up to 34 weeks after treatment start date

InterventionParticipants (Count of Participants)
PA21 (Velphoro®)6
Calcium Acetate (Phoslyra®)4

[back to top]

25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionnmol/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)81.774.459.0-9.7-21.8
PA21 (Velphoro®)83.179.876.0-4.1-18.3

[back to top]

Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionug/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)55.5556.1571.462.38-4.18
PA21 (Velphoro®)47.7750.3755.317.297.74

[back to top]

Change in Serum Phosphorus (SP) Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline

The levels of Serum Phosphorus considered at baseline are those above vs within/below Age Related Normal Range (NCT02688764)
Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Interventionmmol/L (Least Squares Mean)
SP above Age Related Normal RangeSP below/within Related Normal Range
PA21 (Velphoro®)-0.2820.082

[back to top]

Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group

(NCT02688764)
Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Interventionmmol/L (Least Squares Mean)
>=2 years to <6 years>=6 years to <12 years>=12 years to <=18 years
PA21 (Velphoro®)-0.078-0.200-0.149

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Ferritin Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionug/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)234.28310.46345.1359.27110.69
PA21 (Velphoro®)223.67322.59326.1348.59137.57

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Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionpg/mL (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)814.9767.7747.4-41.847.8
PA21 (Velphoro®)820.1775.7603.5-60.7-187.6

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Iron Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionumol/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)15.2512.6613.08-0.181.35
PA21 (Velphoro®)13.2014.7014.311.641.95

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Osteocalcin-CL Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionug/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)681.5753.1709.020.0-91.0
PA21 (Velphoro®)517.9586.0516.928.420.3

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Serum iPTH Levels at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionpmol/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)37.1245.9052.305.7212.01
PA21 (Velphoro®)30.3628.2835.60-2.494.61

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Serum Phosphorus Values at Each Visit

(NCT02688764)
Timeframe: through study completion, up to 34 weeks after treatment start date

,
Interventionmmol/L (Mean)
BaselineEnd of Stage 1End of Stage 2
Calcium Acetate (Phoslyra®)2.152.172.09
PA21 (Velphoro®)2.071.821.71

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Serum Total Corrected Calcium at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionmmol/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)2.372.312.36-0.06-0.07
PA21 (Velphoro®)2.382.352.28-0.03-0.06

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Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline

Summary statistics of Serum total corrected calcium-phosphorus product at each time point and change from baseline, where serum total corrected calcium-phosphorus product correspond to the product of serum total calcium and Phosphorus, expressed in mmol^2/L^2 (NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionmmol^2/L^2 (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)5.315.054.90-0.31-0.12
PA21 (Velphoro®)4.944.253.91-0.65-0.49

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Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
InterventionU/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)8.828.827.62-0.11-0.16
PA21 (Velphoro®)8.868.558.250.020.72

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Transferrin Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventiong/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)1.991.971.98-0.05-0.12
PA21 (Velphoro®)2.121.961.89-0.17-0.28

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Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionug/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)4.315.104.43-0.03-0.34
PA21 (Velphoro®)4.774.574.21-0.45-0.42

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Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline

(NCT02688764)
Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

,
Interventionumol/L (Mean)
BaselineEnd of Stage 1 - Observed dataEnd of Stage 2 - Observed dataEnd of Stage 1 - Change from baselineEnd of Stage 2 - Change from baseline
Calcium Acetate (Phoslyra®)25.5427.2826.04-0.81-3.53
PA21 (Velphoro®)28.6825.3725.53-3.64-4.38

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Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage

"Number and percentages of participants with serum phosphorus levels below, within and above age-dependent target ranges at baseline, at the end of Stage 1 and at the end of Stage 2.~The age target ranges for serum phosphorus levels are:~0 to <1 year 1.62-2.52 mmol/L~1 year to <6 years 1.45-2.10 mmol/L~6 years to <13 years 1.16-1.87 mmol/L~13 years to ≤18 years 0.74-1.45 mmol/L" (NCT02688764)
Timeframe: through study completion, up to 34 weeks after treatment start date

InterventionParticipants (Count of Participants)
Baseline72576853Baseline72576854End of Stage 172576853End of Stage 172576854End of Stage 272576853End of Stage 272576854
BelowWithinAbove
PA21 (Velphoro®)11
PA21 (Velphoro®)52
Calcium Acetate (Phoslyra®)13
PA21 (Velphoro®)2
Calcium Acetate (Phoslyra®)1
PA21 (Velphoro®)37
Calcium Acetate (Phoslyra®)12
PA21 (Velphoro®)1
Calcium Acetate (Phoslyra®)0
PA21 (Velphoro®)14
Calcium Acetate (Phoslyra®)2
PA21 (Velphoro®)25
Calcium Acetate (Phoslyra®)6

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Change in Serum Phosphorus (s-P) Level From Baseline to Week 4.

Difference in mean change from baseline in s-P level at Week 4 between the tenapanor and placebo groups. (NCT03824587)
Timeframe: 4 Weeks (28 days randomization period; from baseline to week 4)

Interventionmg/dL (Least Squares Mean)
Tenapanor 30 mg BID-0.84
Placebo-0.19

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Relative Change From Baseline in cFGF23 at Week 4

cFGF23 at Week 4/baseline cFGF23 - 1 (NCT03824587)
Timeframe: 4 Weeks (28 days randomization period)

Interventionpg/mL (Geometric Least Squares Mean)
Tenapanor 30 mg BID0.779
Placebo0.947

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Relative Change From Baseline in iFGF23 at Week 4

iFGF23 at Week 4/baseline iFGF23 - 1 (NCT03824587)
Timeframe: 4 Weeks (28 days randomization period)

Interventionpg/mL (Geometric Least Squares Mean)
Tenapanor 30 mg BID0.756
Placebo0.931

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s-P Response at Week 4

Achieving an s-P level <5.5 mg/dL (NCT03824587)
Timeframe: 4 Weeks (28 days randomization period)

InterventionParticipants (Count of Participants)
Tenapanor 30 mg BID43
Placebo26

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