Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Phase 2
Completed
- Conditions
- Kidney Failure, Chronic
- Interventions
- Registration Number
- NCT00853242
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 349
Inclusion Criteria
- Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy
- Men or women 18 years or older
Exclusion Criteria
- Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks. Genz-644470 2.4 Grams Per Day (g/day) Genz-644470 Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 4.8 g/day Genz-644470 Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Genz-644470 7.2 g/day Genz-644470 Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 2.4 g/day Sevelamer carbonate Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 4.8 g/day Sevelamer carbonate Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. Sevelamer Carbonate 7.2 g/day Sevelamer carbonate Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) Baseline, Day 22
- Secondary Outcome Measures
Name Time Method Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) Baseline, Day 22 Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22 Baseline, Day 22 Change From Baseline in Total Cholesterol at Day 22 Baseline, Day 22 Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22 Baseline, Day 22