RENVELA for ORAL SUSPENSION Rx

Cross-Over Study of Sevelamer Carbonate (Renvela) 800 mg Tablets and Sevelamer Hydrochloride (Renagel) 800 mg Tablets

• The double-blind, active-controlled, cross-over clinical study included Stage 5 CKD patients (n=79) on hemodialysis who entered into a 5-week sevelamer hydrochloride run-in period, then were randomly assigned to receive either sevelamer carbonate 800mg tablets and sevelamer hydrochloride 800mg tablets for 8 weeks each, with no intervening washout. At the end of each of the 2 cross-over periods, the phosphorus levels were similar.

Cross-Over Study of Sevelamer Carbonate (Renvela) Powder and Sevelamer Hydrochloride (Renagel) Tablets

• The clinical study included Stage 5 CKD patients on hemodialysis who entered a 4-week sevelamer hydrochloride run-in period, then were randomly assigned to receive either sevelamer carbonate powder and sevelamer hydrochloride tablets for 4 weeks each with no intervening washout. At the end of each of the 2 cross-over periods, the phosphorus levels were similar.

Clinical Study of Sevelamer Carbonate (Renvela) Powder and Tablets in Pediatric Patients

• The clinical study included 101 patients 6 to 18 years of age with CKD on a phosphate binder. Patients were entered into a 2-week, double-blind, fixed-dose period (FDP) in which they were randomly assigned to receive sevelamer carbonate or placebo, and a 26-week, open-label, sevelamer carbonate dose titration period (DTP).

• Sevelamer carbonate significantly reduced serum phosphorus through Week 2 (primary endpoint) by an LS Mean difference of -0.90 (SE 0.27) mg/dL compared to placebo (P =.001). A similar treatment response was observed in patients who received sevelamer carbonate during the 6-month open-label DTP. Approximately 30% of subjects reached their target serum phosphorus.

Sevelamer Hydrochloride versus Active-Control, Cross-Over Study in Hemodialysis Patients

• The clinical study included 84 CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus >6.0 mg/dL). After a 2-week phosphate binder washout period, patients were randomly assigned in a cross-over design to receive either sevelamer hydrochloride and active control for 8 weeks each. Over each 8-week treatment period, at 3 separate time points the dose of sevelamer hydrochloride could be titrated up to control serum phosphorus.

• Both treatments significantly decreased mean serum phosphorus by about 2 mg/dL. The median response is a reduction of about 2 mg/dL in both groups. About 50% of subjects have reductions between 1 and 3 mg/dL.

Sevelamer Hydrochloride versus Active Control in Hemodialysis Patients

• The clinical study included 200 CKD patients on hemodialysis who were hyperphosphatemic (serum phosphorus >5.5 mg/dL). After a 2-week phosphate binder washout period, patients were randomly assigned to receive either sevelamer hydrochloride 800mg tablets or an active control. 

• Sevelamer and active control achieved a significant decrease in mean serum phosphorus at week 52.

Sevelamer Hydrochloride versus Active Control in Peritoneal Dialysis Patients

• The clinical study included 143 patients on peritoneal dialysis who were hyperphosphatemic (serum phosphorus >5.5 mg/dL). After a 2-week phosphate binder washout period, patients were randomly assigned to receive either sevelamer hydrochloride or an active control open label for 12 weeks. 

• At the end of treatment, the average daily sevelamer hydrochloride dose was 5.9g (range, 0.8 to 14.3g).

• Sevelamer achieved statistically significant changes in serum phosphorus of -1.6 mg/dL (P <.001) which was similar to the active control.