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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01736150 | Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis | PHASE3 | COMPLETED | 205 | — | — | Mar 1, 2010 | Sep 1, 2010 | Mar 23, 2015 | 18 | China |
| NCT00681941 | An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis | PHASE3 | COMPLETED | 49 | — | — | Jan 1, 2006 | Mar 1, 2007 | Mar 20, 2015 | 25 | Australia, Denmark +3 |
| NCT00440648 | Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate | PHASE2 | COMPLETED | 80 | — | — | Mar 1, 2005 | Jul 1, 2006 | Mar 19, 2014 | 15 | United States |
| Arm | Type | Description |
|---|---|---|
| Sevelamer carbonate | EXPERIMENTAL | Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. |
| Placebo | PLACEBO_COMPARATOR | Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (\>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. |
| 1 | EXPERIMENTAL | Sevelamer Carbonate Tablets Dosed Three Times A Day |
| 2 | OTHER | sevelamer hydrochloride w(1-8) sevelamer carbonate w(9-16) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | * Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals. |
| Sevelamer carbonate | DRUG | * Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals. * If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals. |
| Sevelamer carbonate (Renvela®) | DRUG | Sevelamer Carbonate Tablets Dosed Three Times A Day |
| sevelamer carbonate, sevelamer hydrochloride | DRUG | Starting dose individualized for each patient and fixed daily dose throughout both treatment periods |
| sevelamer hydrochloride, sevelamer carbonate | DRUG | Starting dose individualized for each patient and fixed daily dose throughout both treatment periods |
Inclusion Criteria: * On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study * Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1 * Have a central laboratory serum phosphorus measure...