Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sevelamer · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Sevelamer Hydrochloride (Renagel®) | EXPERIMENTAL | - |
| Calcium acetate (PhosLo® ) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sevelamer Hydrochloride (Renagel®) | DRUG | Sevelamer hydrochloride three times per day with each meal |
| Calcium acetate (PhosLo® ) | DRUG | Calcium acetate three times per day with each meal |
| Sevelamer hydrochloride | DRUG | - |
Inclusion Criteria: * Willing and able to sign an informed consent form. * Men or women aged 18 years of age or older. * A diagnosis of Chronic Kidney Disease (CKD) and receiving peritoneal dialysis (Continuous cyclical peritoneal dialysis (CAPD), Automated peritoneal dialysis (APD) or Continuous c...
Sevelamer is used for Chronic Kidney Disease and Peritoneal Dialysis. It is being studied in patients with these conditions, including those undergoing peritoneal dialysis. The drug is a small molecule being developed by Sanofi for the nephrology therapeutic area.
Sanofi (ticker: SNY) is developing Sevelamer. The drug is a small molecule being studied for Chronic Kidney Disease and Peritoneal Dialysis. Sanofi is conducting clinical trials to evaluate its safety and efficacy in these patient populations.
Sevelamer is in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 3 trial. The drug is investigational and not yet approved, as it is still undergoing clinical evaluation for Chronic Kidney Disease and Peritoneal Dialysis.
Sevelamer has completed two clinical trials. NCT00196755 was a Phase 3 study comparing Sevelamer with calcium acetate in peritoneal dialysis patients with Chronic Kidney Disease, enrolling 138 participants. NCT00324376 was a Phase 2 study comparing once-daily versus three-times-daily Sevelamer dosing in Chronic Kidney Disease, enrolling 24 participants.
Sevelamer is not FDA approved. It is an investigational drug currently in clinical development. The completed trials include a Phase 2 and a Phase 3 study, but the drug has not received approval for Chronic Kidney Disease or Peritoneal Dialysis.