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Also known as Sevelamer carbonate, Sevelamer Carbonate (GZ419831), Sevelamer carbonate (Renvela®)
sevelamer carbonate, sevelamer · 8 trials · 8 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.
This outcome measure documented the effect of intestinal phosphate-binding on \[PTH\]. Fractional change was calculated as (\[PTH\]post - \[PTH\]pre)/\[PTH\]pre, where 'pre' and 'post' referred respectively to baseline \[PTH\] (before treatment) and \[PTH\] after four weeks of treatment. Reductions were cited as negative numbers, and increments were cited as positive numbers.
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 | ACTIVE_COMPARATOR | 2400 mg (3 pills) with each meal |
| placebo control | PLACEBO_COMPARATOR | 3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets. |
| 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 | 2400 mg with each meal for 4 weeks |
| 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 ...
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Sevelamer carbonate is used to treat hyperphosphatemia, which is elevated phosphate levels, in people with chronic kidney disease. It is also studied in related kidney conditions including renal failure and hyperparathyroidism. It is a small molecule therapy in the nephrology area developed by Sanofi.
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 nephrology therapy.
Sevelamer carbonate is in Phase 3 development. Its clinical program includes Phase 3 trials, and the drug is investigational rather than approved. The Phase 3 studies have been completed, and no active trials are currently listed.
Sevelamer carbonate has been studied in completed trials including NCT03001011 in China, NCT02332811 in Russia, NCT01736150 in China, and a pediatric Phase 2 study, NCT01574326, conducted in the United States, France, Germany, Lithuania, and Poland. These trials enrolled patients with chronic kidney disease and hyperphosphatemia.
Sevelamer carbonate and sevelamer hydrochloride are related forms of sevelamer. Sevelamer carbonate is also known as Renvela and has been referred to as GZ419831. Both are used in the management of hyperphosphatemia in chronic kidney disease, but they are distinct salt forms.