Summary
Sevelamer Hydrochloride 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 Hydrochloride to Chronic Kidney Disease: 8 have completed. The most advanced is Phase 4 (NCT00324571). The largest enrolment is 3520 participants (NCT01431326). Registration activity spans 2001 to 2011. The literature layer holds 13 publications for this pair: 2 Cochrane reviews, 3 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2003 to 2018. 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 | 79.0 (trials 29.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other |
| Linked publications | 13 (5 clinical trial publications, 3 meta-analyses, 2 Cochrane reviews, 2 randomised controlled trial publications, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00324571 | Dialysis Clinical Outcomes Revisited (DCOR) Trial 2001 | completed | Phase 4 | 2,000 |
| NCT00196755 | Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis 2004 | completed | Phase 3 | 138 |
| NCT00441545 | Head to Head Study Against Sevelamer Hydrochloride 2007 | completed | Phase 3 | 182 |
| NCT00324376 | Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing 2003 | completed | Phase 2 | 24 |
| NCT00704483 | Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis 2008 | completed | Phase 2 | 321 |
| NCT00824460 | Study of Phosphate Levels in Patients With Chronic Kidney Disease 2008 | completed | Phase 2 | 154 |
| NCT01431326 | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care 2011 | completed | Not applicable | 3,520 |
| NCT01049815 | Sevelamer Hydrochloride and Femoral and Carotid Intima Media Thickness Progression in End Stage Renal Disease 2005 | completed | Not applicable | 175 |
Published literature
- Cochrane review A meta-analysis of phosphate binders lanthanum carbonate versus sevelamer hydrochloride in patients with end-stage renal disease undergoing hemodialysisZhou T, Li H, Xie W et al. · African health sciences · 2018 · PMID 30603002
- Clinical trial publication Efficacy and safety of sucroferric oxyhydroxide compared with sevelamer hydrochloride in Japanese haemodialysis patients with hyperphosphataemia: A randomized, open-label, multicentre, 12-week phase III studyKoiwa F, Yokoyama K, Fukagawa M et al. · Nephrology (Carlton, Vic.) · 2017 · PMID 27496336
- 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
- Clinical trial publication Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal diseaseKeith MS, Wilson RJ, Preston P et al. · Clinical therapeutics · 2014 · PMID 25069799
- Clinical trial publication Dose-finding study of bixalomer in patients with chronic kidney disease on hemodialysis with hyperphosphatemia: a double-blind, randomized, placebo-controlled and sevelamer hydrochloride-controlled open-label, parallel group studyAkizawa T, Origasa H, Kameoka C et al. · Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2014 · PMID 24975892
- Clinical trial publication Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trialAkizawa T, Tsuruta Y, Okada Y et al. · BMC nephrology · 2014 · PMID 24968790
- Clinical trial publication Clinical effects of long-term (36-month) lanthanum carbonate administration in hemodialysis patients in JapanKishi Y, Obara Y, Hara K et al. · Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2014 · PMID 24953760
- Randomized controlled trial Randomized controlled trial of bixalomer versus sevelamer hydrochloride in hemodialysis patients with hyperphosphatemiaAkizawa T, Origasa H, Kameoka C et al. · Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2014 · PMID 24720402
- Randomized controlled trial Clinical efficacy, safety and anti-inflammatory activity of two sevelamer tablet forms in patients on low-flux hemodialysisTzanno-Martins C, Biavo BM, Ferreira-Filho O et al. · International journal of immunopathology and pharmacology · 2014 · PMID 24674676
- Meta-analysis Efficacy and safety of lanthanum carbonate on chronic kidney disease-mineral and bone disorder in dialysis patients: a systematic reviewZhang C, Wen J, Li Z et al. · BMC nephrology · 2013 · PMID 24134531
- Systematic review The phosphate binder equivalent doseDaugirdas JT, Finn WF, Emmett M et al. · Seminars in dialysis · 2011 · PMID 21338393
- Meta-analysis Meta-analysis of the effect of sevelamer on phosphorus, calcium, PTH, and serum lipids in dialysis patientsBurke SK, Dillon MA, Hemken DE et al. · Advances in renal replacement therapy · 2003 · PMID 12879374
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 Hydrochloride approved for Chronic Kidney Disease?
Sevelamer Hydrochloride 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 Hydrochloride in clinical trials for Chronic Kidney Disease?
ClinicalTrials.gov lists 8 registered trials linking Sevelamer Hydrochloride to Chronic Kidney Disease: 8 have completed. The most advanced is Phase 4 (NCT00324571). The largest enrolment is 3520 participants (NCT01431326). Registration activity spans 2001 to 2011.
What does the evidence show for Sevelamer Hydrochloride in Chronic Kidney Disease?
Sevelamer Hydrochloride 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.