Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00853242 | Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis | PHASE2 | COMPLETED | 349 | — | — | Feb 1, 2009 | Aug 1, 2009 | May 1, 2015 | 53 | United States, Puerto Rico |
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 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) | EXPERIMENTAL | Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. |
| Genz-644470 4.8 g/day | EXPERIMENTAL | Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. |
| Genz-644470 7.2 g/day | EXPERIMENTAL | Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. |
| Sevelamer Carbonate 2.4 g/day | ACTIVE_COMPARATOR | Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. |
| Sevelamer Carbonate 4.8 g/day | ACTIVE_COMPARATOR | Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. |
| Sevelamer Carbonate 7.2 g/day | ACTIVE_COMPARATOR | Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| Genz-644470 | DRUG | - |
| Sevelamer carbonate | DRUG | - |
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 ...