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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00268957 |
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.
Condition | Intervention | Phase |
---|---|---|
Kidney Diseases Chronic Renal Insufficiency End-Stage Renal Disease |
Drug: Sevelamer carbonate (Renvela®) Drug: Sevelamer hydrochloride (Renagel®) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Parallel, Open-Label Study to Compare Once Per Day Sevelamer Carbonate Powder Dosing With Three Times Per Day Sevelamer Hydrochloride Tablet Dosing in Chronic Kidney Disease Patients on Hemodialysis |
Enrollment: | 217 |
Study Start Date: | January 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
sevelamer carbonate powder
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Drug: Sevelamer carbonate (Renvela®)
sevelamer carbonate powder dosed once per day with largest meal
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2: Active Comparator
Sevelamer hydrochloride
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Drug: Sevelamer hydrochloride (Renagel®)
Sevelamer hydrochloride tablets dosed three times a day with meals
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Jeremy Heaton, M.D. | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | GD3-199-301 |
Study First Received: | December 22, 2005 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00268957 |
Health Authority: | United States: Food and Drug Administration |
Chronic Hemodialysis Kidney |
Hyperphosphatemia Chronic kidney disease Chronic Renal Insufficiency |
Sevelamer Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Hyperphosphatemia Kidney Diseases Kidney Failure |
Molecular Mechanisms of Pharmacological Action Chelating Agents Pharmacologic Actions |