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Renagel (Sevelamer Hydrochloride) - Summary

 
 



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)

Effect of gastric acid suppression with pantoprazole on the efficacy of sevelamer hydrochloride as a phosphate binder in haemodialysis patients: a pilot study. [2012]
Sevelamer hydrochloride (HCL) is thought to require an appropriately acidic environment in order to bind gastrointestinal phosphate. Changes in gastric acidity with acid suppressants may therefore alter the efficacy of sevelamer HCL... Although our study did not find a significant drug interaction, given the high prevalence of acid suppressant use in dialysis patients, physicians should be aware of the potential influence of acid suppression on the efficacy of phosphate binders and regularly assess the clinical need for acid suppression therapy.

Comparison of Calcium Acetate and Sevelamer on Vascular Function and Fibroblast Growth Factor 23 in CKD Patients: A Randomized Clinical Trial. [2011.11.30]
BACKGROUND: Fibroblast growth factor 23 (FGF-23) is a marker of endothelial dysfunction and atherosclerotic complications in patients with chronic kidney disease (CKD). Because previous studies suggested that sevelamer may exert effects on FGF-23 level and endothelial function independently of its phosphate-lowering action, we tested the effect of sevelamer versus calcium acetate on vascular function and FGF-23 levels... CONCLUSIONS: In hyperphosphatemic patients with stage 4 CKD, treatment with phosphate lowering induces measurable improvements in flow-mediated vasodilatation. Furthermore, independently of serum phosphate level, FGF-23 level changes induced by phosphate binders are associated with simultaneous changes in flow-mediated vasodilatation. These observations are compatible with the hypothesis that FGF-23 may contribute to vascular dysfunction in this population. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study. [2011.05]
BACKGROUND: Lanthanum carbonate and sevelamer carbonate are noncalcium phosphate binders used to treat hyperphosphatemia in patients with chronic kidney disease. This is the first study to compare phosphate absorption from a standardized meal ingested with a typical clinical dose of these binders... CONCLUSIONS: In healthy volunteers, 1,000 mg of lanthanum carbonate decreased phosphate absorption by 45% compared with a 21% decrease with 2,400 mg of sevelamer carbonate. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

The effect of sevelamer carbonate and lanthanum carbonate on the pharmacokinetics of oral calcitriol. [2011.05]
BACKGROUND: Lanthanum carbonate and sevelamer carbonate are non-calcium-based phosphate binders used to manage hyperphosphataemia in patients with chronic kidney disease (CKD). Patients with CKD may require intravenous or oral active vitamin D. We investigated the effects of lanthanum carbonate and sevelamer carbonate on the bioavailability of oral calcitriol... CONCLUSIONS: Sevelamer carbonate significantly reduces serum concentrations of exogenous calcitriol when administered concomitantly with oral calcitriol, whereas lanthanum carbonate has no significant effect. This should be considered when treating CKD patients who require phosphate binders and oral vitamin D.

Effect of sevelamer and calcium-based phosphate binders on coronary artery calcification and accumulation of circulating advanced glycation end products in hemodialysis patients. [2011.03]
BACKGROUND: Some trials have indicated that coronary artery calcification progresses more slowly in sevelamer-treated dialysis patients than in those using calcium-based binders. Effects of phosphate binders on circulating advanced glycation end products (AGEs) are unknown... CONCLUSIONS: The data suggest that sevelamer treatment slowed the increase in CACS and suppressed AGE accumulation. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

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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]
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 [PhosLoŽ]/Sevelamer[RenagelŽ] 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

Nicotinamide Versus Sevelamer Hydrochloride on Phosphatemia Control on Chronic Hemodialysed Patients [Recruiting]
The comparison between nicotinamide and sevelamer aims to demonstrate, in chronic hemodialysed patients, the non-inferiority of nicotinamide in terms of control of the phosphatemia. Secondary objectives is to compare the two treatments in terms of efficiency in other biological parameters, vascular calcification and bone mass loss and on the clinical and biological tolerance and finally to explore the roles of metabolites of nicotinamide.

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Reports of Suspected Renagel (Sevelamer) Side Effects

Thrombocytopenia (12)Anaemia (12)Abdominal Pain Upper (6)Constipation (5)Gastric Ulcer (5)Liver Disorder (5)Large Intestine Perforation (5)Renal Impairment (5)Klebsiella Infection (4)Melaena (4)more >>


Page last updated: 2013-02-10

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