An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients
Phase 3
Completed
- Conditions
- Renal Failure Chronic
- Interventions
- Registration Number
- NCT02332811
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
Primary Objective:
Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis
Secondary Objective:
Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)
- Detailed Description
10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKD patients not on dialysis 800 mg sevelamer carbonate 800mg Sevelamer carbonate 800 mg in tabs 3 times per day with meals CKD patients on dialysis 800 mg sevelamer carbonate 800mg Sevelamer carbonate 800 mg in tabs 3 times per day with meals CKD patients not on dialysis 2.4 g sevelamer carbonate 2.4 g Sevelamer carbonate 2.4 g powder carbonate per day CKD patients on dialysis 2.4 g sevelamer carbonate 2.4 g Sevelamer carbonate 2.4 g powder carbonate per day
- Primary Outcome Measures
Name Time Method The reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis up to 8 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Russia
🇷🇺Moscow, Russian Federation