Summary
Sevelamer Carbonate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. ClinicalTrials.gov lists 8 registered trials linking Sevelamer Carbonate to Chronic Kidney Disease: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01277497). The largest enrolment is 3520 participants (NCT01431326). Registration activity spans 2006 to 2020. The literature layer holds 8 publications for this pair: 1 Cochrane review, 1 meta-analysis, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2016 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Chronic Kidney Disease ranks 534 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GFR decline averages 2-5 mL/min/year on standard care (ACE/ARB + blood pressure control); progression to end-stage renal disease (ESRD) in ~20-30% at 10 years for moderate CKD; reversal essentially impossible once structural fibrosis established.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 70.0 (trials 28.0, literature 22.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 8 (5 clinical trial publications, 1 Cochrane review, 1 meta-analysis, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01277497 | Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4 2011 | terminated | Phase 4 | 30 |
| NCT03001011 | Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China 2017 | completed | Phase 3 | 202 |
| NCT00681941 | An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis 2006 | completed | Phase 3 | 49 |
| NCT03984760 | Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis 2019 | completed | Phase 3 | 240 |
| NCT00853242 | Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis 2009 | completed | Phase 2 | 349 |
| NCT04551300 | A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients 2020 | completed | Phase 2 | 158 |
| NCT02684643 | Study of Individualized Therapy on Hyperphosphatemia in Maintenance Hemodialysis Patients 2016 | completed | Not applicable | 72 |
| NCT01431326 | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care 2011 | completed | Not applicable | 3,520 |
Published literature
- Clinical trial publication Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysisZhuang B, Gan L, Liu B et al. · Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2024 · PMID 38453435
- Clinical trial publication Efficacy and Safety of Ferric Citrate on Hyperphosphatemia among Chinese Patients with Chronic Kidney Disease Undergoing Hemodialysis: A Phase III Multicenter Randomized Open-Label Active-Drug-Controlled StudyWang Y, Chen X, Zhu H et al. · American journal of nephrology · 2023 · PMID 37812931
- Clinical trial publication Characteristics of Patients Who Achieve Serum Phosphorus Control on Sucroferric Oxyhydroxide or Sevelamer Carbonate: A post hoc Analysis of a Phase 3 StudyCovic AC, Sprague SM, Rastogi A et al. · Nephron · 2020 · PMID 32585670
- Clinical trial publication Effect of calcitriol combined with sevelamer carbonate on serum parathyroid hormone in patients with chronic renal failureZheng H, Liu Z · Cellular and molecular biology (Noisy-le-Grand, France) · 2020 · PMID 32415923
- Clinical trial publication Differential effects of phosphate binders on vitamin D metabolism in chronic kidney diseaseGinsberg C, Zelnick LR, Block GA et al. · Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2020 · PMID 32160298
- Randomized controlled trial The Effect of Sevelamer on Serum Levels of Gut-Derived Uremic Toxins: Results from In Vitro Experiments and A Multicenter, Double-Blind, Placebo-Controlled, Randomized Clinical TrialBennis Y, Cluet Y, Titeca-Beauport D et al. · Toxins · 2019 · PMID 31109001
- Meta-analysis The efficacy and safety of sevelamer and lanthanum versus calcium-containing and iron-based binders in treating hyperphosphatemia in patients with chronic kidney disease: a systematic review and meta-analysisHabbous S, Przech S, Acedillo R et al. · Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2017 · PMID 27651467
- Cochrane review Comparative Effectiveness of Phosphate Binders in Patients with Chronic Kidney Disease: A Systematic Review and Network Meta-AnalysisSekercioglu N, Thabane L, Díaz Martínez JP et al. · PloS one · 2016 · PMID 27276077
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sevelamer Carbonate approved for Chronic Kidney Disease?
Sevelamer Carbonate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Chronic Kidney Disease would be drug repurposing rather than first-in-human development. This does not mean it is approved for Chronic Kidney Disease. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sevelamer Carbonate in clinical trials for Chronic Kidney Disease?
ClinicalTrials.gov lists 8 registered trials linking Sevelamer Carbonate to Chronic Kidney Disease: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01277497). The largest enrolment is 3520 participants (NCT01431326). Registration activity spans 2006 to 2020.
What does the evidence show for Sevelamer Carbonate in Chronic Kidney Disease?
Sevelamer Carbonate has both completed registered trials and synthesis-level publications linked to Chronic Kidney Disease. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.