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Also known as sevelamer carbonate, sevelamer hydrochloride, Sevelamer carbonate, Sevelamer Carbonate (GZ419831), Sevelamer Carbonate, Sevelamer carbonate (Renvela®), sevelamer carbonate
sevelamer carbonate, sevelamer · 7 trials · 7 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 |
| 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. |
| 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 | 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 powder dosed once per day with largest meal |
| Sevelamer hydrochloride (Renagel®) | DRUG | Sevelamer hydrochloride tablets dosed three times a day with meals |
| 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: * 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 ...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 11 | PHASE3 | Savolitinib, Baxdrostat, Zibotentan/Dapagliflozin, Dapagliflozin, AZD4248 |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Retatrutide, Orforglipron, LY3841136, SGLT2 inhibitor |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Zigakibart, OJR520 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 3 | PHASE3 | DCR-PHXC, NNC0519-0130, Semaglutide |
| Amgen Inc. | AMGN | 1 | PHASE3 | Etelcalcetide |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Mezagitamab |
| ProKidney Corp. Class A | PROK | 3 | PHASE3 | Rilparencel |
| Humacyte, Inc. | HUMA | 1 | PHASE3 | Symvess |
| Fresenius Medical Care AG Sponsored ADR | FMS | 6 | PHASE2 | Difelikefalin |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4771261 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | Vonsetamig |
| United Therapeutics Corporation | UTHR | 2 | PHASE1 | 10 GE Xenokidney, GGTA1 KO Thymokidney |
| Pfizer Inc. | PFE | 1 | PHASE1 | PF-07328948 |
| OPKO Health, Inc. | OPK | 1 | PHASE2 | CTAP101 |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB123667 |
Sevelamer carbonate is used to treat hyperphosphatemia, meaning elevated phosphate levels, in people with chronic kidney disease. It is studied in patients with chronic kidney disease, including those on hemodialysis and those not on dialysis, as well as in pediatric patients with chronic kidney disease and hyperphosphatemia.
Sevelamer carbonate is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company associated with the clinical development program for this small molecule in nephrology.
Sevelamer carbonate is in Phase 3 development. Its clinical program includes Phase 3 trials in hyperphosphatemia and chronic kidney disease, along with a completed Phase 2 trial in pediatric patients. It is an investigational therapy in the studies described here.
Sevelamer carbonate has been studied in completed trials including NCT03001011 in China, NCT02332811 in Russia, NCT01736150 in China, and the pediatric Phase 2 trial NCT01574326 across the United States, France, Germany, Lithuania, and Poland. These trials enrolled patients with hyperphosphatemia, chronic kidney disease, and renal failure.
Sevelamer carbonate and sevelamer hydrochloride are related forms of sevelamer. Sevelamer carbonate is also known as sevelamer, Sevelamer Carbonate (GZ419831), and Sevelamer carbonate (Renvela). Searches for sevelamer, sevelamer carbonate 800mg, and Renvela refer to this same drug asset.
In chronic kidney disease, sevelamer carbonate is used to manage hyperphosphatemia, the elevated blood phosphate that commonly accompanies reduced kidney function. Trials have evaluated it in patients on hemodialysis and in patients not on dialysis, with phosphate control as the focus of treatment.