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A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder. Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Gambro Healthcare-Gadsden
Gadsden, Alabama, United States
nTouch Research
Huntsville, Alabama, United States
Kidney Health Institute, LLC
Tucson, Arizona, United States
Gambro Healthcare
El Cerrito, California, United States
Palomar Medical Group
Escondido, California, United States
Gambro Healthcare-Los Angeles
Los Angeles, California, United States
Balboa Nephrology Medical Group
San Diego, California, United States
Nephrology Educational Services and Research
Tarzana, California, United States
Lowry Dialysis Center
Denver, Colorado, United States
Nephrology Associates, P.C.
Bridgeport, Connecticut, United States
Start Date
March 1, 2001
Completion Date
February 1, 2006
Last Updated
March 18, 2015
2,000
Estimated participants
Sevelamer hydrochloride
DRUG
Calcium-based phosphate binder
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