Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
Summary
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Kidney Diseases
Intervention
Sevelamer carbonate (Renvela®), Sevelamer hydrochloride (Renagel®)
Location
Clinical Research Center
Birmingham
Alabama
United States
35213
Status
Completed
Source
Genzyme
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00268957
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Kidney Papillary Necrosis
A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.
Hydronephrosis
Abnormal enlargement or swelling of a KIDNEY due to dilation of the KIDNEY CALICES and the KIDNEY PELVIS. It is often associated with obstruction of the URETER or chronic kidney diseases that prevents normal drainage of urine into the URINARY BLADDER.
National Institute Of Diabetes And Digestive And Kidney Diseases...
Component of the NATIONAL INSTITUTES OF HEALTH. It conducts and supports basic and applied research for a national program in diabetes, endocrinology, and metabolic diseases; digestive diseases and nutrition; and kidney, urologic, and hematologic diseases. It was established in 1948.
Kidney Diseases, Cystic
A heterogeneous group of hereditary and acquired disorders in which the KIDNEY contains one or more CYSTS unilaterally or bilaterally (KIDNEY, CYSTIC).
Chemistry, Inorganic
A field of chemistry which pertains to chemical compounds or ions that do not contain the element carbon (with the exception of carbon dioxide and compounds containing a carbonate radical, e.g., calcium carbonate).
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PubMed Articles
A sensitive and rapid ion chromatography (IC) method was developed for the low level determination of allylamine (AAM) in sevelamer (SVM) drug substances, i.e., sevelamer hydrochloride (SVH) and sevel...
Sevelamer Carbonate Reduces Inflammation and Endotoxemia in an Animal Model of Uremia.
Background: Renal failure is associated with activation of inflammatory response, but the mechanisms behind this observation and potential anti-inflammatory strategies are yet to be defined. Endotoxin...
Sevelamer use and incidence of peritonitis in peritoneal dialysis.
BACKGROUND: Sevelamer, a non-calcium containing phosphate binder often used in end-stage renal disease, is frequently associated with gastrointestinal side effects. However, whether Sevelamer is also...
Objective: To investigate the effects of phosphonoformic acid (PFA) and sevelamer hydrochloride (Renagel) on renal type IIa sodium-dependent phosphate cotransporter (NaPi-2) mRNA expression in hyperph...
We compared the effects of calcitriol and doxercalciferol, in combination with either calcium carbonate or sevelamer, on bone, mineral, and fibroblast growth factor-23 (FGF-23) metabolism in patients...
