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NCT00196755
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
Phase 3 trial testing Sevelamer Hydrochloride (Renagel®) in Peritoneal Dialysis in 138 participants. Completed in 1 April 2006.
1 March 2006
Quick facts
| Lead sponsor | Genzyme, a Sanofi Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 138 |
| Start date | 1 December 2004 |
| Primary completion | 1 March 2006 |
| Estimated completion | 1 April 2006 |
| Sites | 17 locations across Belgium, Denmark, France, Italy, Netherlands, Spain, United Kingdom |
Drugs / interventions tested
- Sevelamer Hydrochloride (Renagel®) — full drug profile →
- Calcium acetate (PhosLo® ) — full drug profile →
Conditions studied
- Peritoneal Dialysis — all drugs for Peritoneal Dialysis →
- Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
Sponsor
Genzyme, a Sanofi Company — full company profile →
Who can join
18 and older, any sex, with Peritoneal Dialysis or Chronic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.
Time frame: 12 weeks
Sponsor's own description
The purpose of this study is to demonstrate that sevelamer hydrochloride is non-inferior to calcium acetate for the treatment of hyperphosphataemia in patients receiving peritoneal dialysis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00196755
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peritoneal Dialysis
Currently open trials in the same condition.
- NCT07098351 — Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis · NA · recruiting
- NCT07077538 — Clinical Study of the Use of Amino Acid Peritoneal Dialysate in Diabetic Patients · NA · recruiting
- NCT06876987 — The Mobile-based Training System in Peritoneal Dialysis Patients · NA · recruiting
- NCT06641765 — Continuous Glucose Monitoring in Dialysis Patients With Diabetes · NA · active not recruiting
- NCT06368713 — Exercise Improves Gastrointestinal Function in Peritoneal Dialysis Patients · NA · recruiting
Other Genzyme, a Sanofi Company trials
Trials by the same sponsor.
- NCT06666413 — China Post-approval Commitment (PAC) Study of Avalglucosidase Alfa in Participants With IOPD · Phase 4 · recruiting
- NCT05164055 — Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase) · Phase 4 · active not recruiting
- NCT05134571 — China Post-marketing Surveillance (PMS) Study of Aldurazyme® · Phase 4 · completed
- NCT05054387 — China Post-marketing Surveillance (PMS) Study of Fabrazyme® · Phase 4 · completed
- NCT04676373 — Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00196755 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Genzyme, a Sanofi Company
- Last refreshed: 17 March 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00196755.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing