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.
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NEWS HIGHLIGHTS
Published Studies Related to Renagel (Sevelamer)
Response of different PTH assays to therapy with sevelamer or CaCO3 and active vitamin D sterols. [2009.07]
Amino-terminally truncated parathyroid hormone (PTH) fragments are detected to differing degrees by first- and second-generation immunometric PTH assays (PTH-IMAs), and acute changes in serum calcium affect the proportion of these fragments in circulation... The PTH values obtained by first- and second-generation PTH-IMAs correlated closely throughout therapy and the response of PTH was similar to both PTH-IMAs, despite differences in serum calcium levels.
Paricalcitol treatment of secondary hyperparathyroidism in hemodialysis patients on sevelamer hydrochloride: which dialysate calcium concentration to use? [2009]
BACKGROUND: Optimal dialysate calcium concentration (DCa) has not been determined under less hypercalcemic vitamin D analogues and Ca-free phosphate (P) binders... CONCLUSIONS: Under paricalcitol and sevelamer, serum parathyroid hormone decreased without Ca increase under any DCa. DCa of 2.5 mEq/l resulted in higher paricalcitol doses, increased serum P levels and more frequent high Ca x P episodes and may not be optimal with the new medications.
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]
BACKGROUND: Previous clinical trials showed that progression of coronary artery calcification (CAC) may be slower in hemodialysis patients treated with sevelamer than those treated with calcium-based phosphate binders. Because sevelamer decreases low-density lipoprotein cholesterol (LDL-C) levels, we hypothesized that intensive lowering of LDL-C levels with atorvastatin in hemodialysis patients treated with calcium acetate would result in CAC progression rates similar to those in sevelamer-treated patients... CONCLUSIONS: With intensive lowering of LDL-C levels for 1 year, hemodialysis patients treated with either calcium acetate or sevelamer experienced similar progression of CAC.
Comparison of sevelamer hydrochloride with colestimide, administered alone or in combination with calcium carbonate, in patients on hemodialysis. [2008.04]
Since hyperphosphatemia in hemodialysis patients can cause secondary hyperparathyroidism and promotes vascular calcification, serum phosphate (Pi) levels must be controlled by phosphate binders. Although sevelamer and colestimide are known as similar non-calcium, non-aluminum phosphate binders in hemodialysis patients, there are no studies that compare the effects of the two agents as either a monotherapy or in combination with calcium carbonate (CaCO3).
Effects of sevelamer hydrochloride and calcium carbonate on renal osteodystrophy in hemodialysis patients. [2008.02]
Disturbances in mineral metabolism play a central role in the development of renal bone disease. In a 54-wk, randomized, open-label study, 119 hemodialysis patients were enrolled to compare the effects of sevelamer hydrochloride and calcium carbonate on bone... Further studies are required to assess whether these changes affect clinical outcomes, such as rates of fracture.
Clinical Trials Related to Renagel (Sevelamer)
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer Hydrochloride Tablets in Haemodialysis Patients [Completed]
The purpose of this study is to determine if sevelamer carbonate powder is an effective
treatment for the control of serum phosphorous levels in patients on dialysis when compared
to sevelamer hydrochloride tablets.
Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With Chronic Kidney Disease on Hemodialysis [Completed]
Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered
into this study at approximately 26 centers in the United States. This study aims to
evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the
largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with
meals. The total length of participation is approximately 24 weeks.
CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients [Completed]
The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and
sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive
technique, electron beam computed tomography (CT) scanning, to measure calcium in the
coronary arteries, the aortic valve, and the mitral valve.
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate [Completed]
This is a double-blind, randomized, cross-over study conducted at centers within the United
States. The study consists of five periods: an up to two-week Screening Period, a 5-week
Run-In Period, two eight-week study treatment periods and a two-week Washout Period.
Patients are assigned randomly (1: 1) to one of two treatment sequences: sevelamer carbonate
for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer
hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks
Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis [Completed]
The purpose of this study is to determine if Renagel® is more effective as a treatment for
patients with peritoneal dialysis compared to calcium acetate.
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