Approval Probability
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Adjusted LOA
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sevelamer carbonate, sevelamer · 3 trials · 3 indications
| 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...
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Sevelamer carbonate is used for hyperphosphatemia, or elevated blood phosphate, in patients with chronic kidney disease, including those with renal failure and those on hemodialysis. It is a small molecule being developed by Sanofi and is currently in Phase 3 clinical development for these kidney-related conditions.
Sevelamer carbonate is a phosphate binder. It works by binding to phosphate in the gastrointestinal tract, reducing its absorption and lowering blood phosphate levels in patients with chronic kidney disease and hyperphosphatemia. This mechanism helps manage the complications of elevated phosphate in these patients.
Sevelamer carbonate is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug for the treatment of hyperphosphatemia in patients with chronic kidney disease.
Sevelamer carbonate is in Phase 3 clinical development for chronic kidney disease and hyperphosphatemia. It is an investigational drug and has not been approved by regulatory authorities. Several Phase 3 trials have been completed, but the drug remains under investigation for these indications.
Sevelamer carbonate has been studied in several completed clinical trials, including NCT00681941, a Phase 3 open-label dose titration study in hyperphosphatemic CKD patients not on dialysis, and NCT01736150, a Phase 3 dose-titration study in CKD patients on hemodialysis. Both trials enrolled adult patients.
Sevelamer carbonate is a different salt form of sevelamer compared to sevelamer hydrochloride. A clinical trial, NCT00440648, was conducted as a cross-over study comparing sevelamer hydrochloride and sevelamer carbonate in patients with chronic kidney disease, indicating they are distinct formulations of the same active moiety.