Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sevelamer carbonate · 4 trials · 6 indications
Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward \[LOCF\] method.
Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (\<=) 4.6 mg/dL (\<=1.49 mmol/L). |
| Renvela | EXPERIMENTAL | Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus \<=4.6 mg/dL (\<=1.49 mmol/L). |
| CKD patients not on dialysis 800 mg | EXPERIMENTAL | Sevelamer carbonate 800 mg in tabs 3 times per day with meals |
| CKD patients not on dialysis 2.4 g | EXPERIMENTAL | Sevelamer carbonate 2.4 g powder carbonate per day |
| CKD patients on dialysis 800 mg | EXPERIMENTAL | Sevelamer carbonate 800 mg in tabs 3 times per day with meals |
| CKD patients on dialysis 2.4 g | EXPERIMENTAL | Sevelamer carbonate 2.4 g powder carbonate per day |
| 1 | EXPERIMENTAL | sevelamer carbonate powder |
| 2 | ACTIVE_COMPARATOR | Sevelamer hydrochloride |
| FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate | PLACEBO_COMPARATOR | Participants received placebo for 2 weeks during the fixed dose period (FDP). Participants received sevelamer carbonate for 26 weeks in dose titration period (DTP). |
| FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate | EXPERIMENTAL | Participants received sevelamer carbonate for 2 weeks during the FDP of the study. Participants received sevelamer carbonate for an additional 26 weeks in DTP. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Sevelamer Carbonate (GZ419831) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| sevelamer carbonate 800mg | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| sevelamer carbonate 2.4 g | DRUG | Pharmaceutical form:powder Route of administration: oral |
| Sevelamer carbonate (Renvela®) | DRUG | sevelamer carbonate powder dosed once per day with largest meal |
| Sevelamer hydrochloride (Renagel®) | DRUG | Sevelamer hydrochloride tablets dosed three times a day with meals |
| Sevelamer carbonate | DRUG | 0.8 g sachets of powder for oral suspension or 800 mg tablets |
Inclusion criteria: * Participants with chronic kidney disease who had not been on dialysis, and were not expected to begin dialysis, or renal transplantation in the next 4 months from the screening visit. * Had serum phosphorus measurement greater than or equal to (\>=) 5.5 mg/dL (1.78 mmol/L) at ...
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.