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A Double-Blind, Cross-Over Design Study of Sevelamer Hydrochloride (Renagel®) and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
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
The study was conducted at 15 centers (2 of which did not enroll any patients). A total of 79 hemodialysis patients were assigned randomly to one of two treatment sequences.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mobile, Alabama, United States
Riverside, California, United States
Greenwood Village, Colorado, United States
Berwyn, Illinois, United States
Crestwood, Illinois, United States
Indianapolis, Indiana, United States
Valparaiso, Indiana, United States
Columbus, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Start Date
March 1, 2005
Primary Completion Date
March 1, 2006
Completion Date
July 1, 2006
Last Updated
March 19, 2014
80
ACTUAL participants
sevelamer carbonate, sevelamer hydrochloride
DRUG
sevelamer hydrochloride, sevelamer carbonate
DRUG
Lead Sponsor
Genzyme, a Sanofi Company
NCT07241390
NCT06926660
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06717698