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Renagel (Sevelamer Hydrochloride) - Summary

 

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RENAGEL SUMMARY

The active ingredient in Renagel * Tablets is sevelamer hydrochloride, a polymeric phosphate binder intended for oral administration. Sevelamer hydrochloride is poly(allylamine hydrochloride) crosslinked with epichlorohydrin in which forty percent of the amines are protonated.

Renagel is indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis. The safety and efficacy of Renagel in CKD patients who are not on hemodialysis have not been studied. In hemodialysis patients, Renagel decreases the incidence of hypercalcemic episodes relative to patients on calcium treatment.

RENAGEL NEWS HIGHLIGHTS

Published Studies Related to Renagel (Sevelamer)

A 1-year randomized trial of calcium acetate versus sevelamer on progression of coronary artery calcification in hemodialysis patients with comparable lipid control: the Calcium Acetate Renagel Evaluation-2 (CARE-2) study. [2008.06]

Comparison of sevelamer hydrochloride with colestimide, administered alone or in combination with calcium carbonate, in patients on hemodialysis. [2008.04]

Effects of sevelamer hydrochloride and calcium carbonate on renal osteodystrophy in hemodialysis patients. [2008.02]

Short-term treatment with sevelamer increases serum fetuin-a concentration and improves endothelial dysfunction in chronic kidney disease stage 4 patients. [2008.01]

The interscan variation of CT coronary artery calcification score: analysis of the Calcium Acetate Renagel Comparison (CARE)-2 study. [2008.01]

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Clinical Trials Related to Renagel (Sevelamer)

Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets in Haemodialysis Patients [Completed]

Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With Chronic Kidney Disease on Hemodialysis [Completed]

CARE-2 (Calcium Acetate [PhosLoŽ]/Sevelamer[RenagelŽ] Evaluation Study 2) for Heart Calcification in Dialysis Patients [Completed]

Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate [Completed]

Study of Safety and Efficacy of RenagelŽ Compared With Calcium Acetate in Patients With Peritoneal Dialysis [Completed]

more>>

Page last updated: 2008-06-22

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