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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00196755 |
The purpose of this study is to determine if Renagel® is more effective as a treatment for patients with peritoneal dialysis compared to calcium acetate.
Condition | Intervention | Phase |
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Peritoneal Dialysis Chronic Kidney Disease |
Drug: Sevelamer Hydrochloride (Renagel®) Drug: Calcium acetate (PhosLo® ) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Randomized, Parallel Design Study to Investigate the Efficacy and Safety of Sevelamer Hydrochloride (Renagel®) Compared With Calcium Acetate in Peritoneal Dialysis Patients |
Enrollment: | 138 |
Study Start Date: | December 2004 |
Study Completion Date: | April 2006 |
Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
sevelamer hydrochloride
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Drug: Sevelamer Hydrochloride (Renagel®)
Sevelamer hydrochloride three times per day with each meal
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2: Active Comparator
Calcium acetate
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Drug: Calcium acetate (PhosLo® )
Calcium acetate three times per day with each meal
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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:
Belgium | |
UZ Gasthuisberg | |
Leuven, Belgium, B-3000 | |
Denmark | |
Aarhus University Hospital | |
Århus N, Denmark, DN-8200 | |
Copenhagen University Hospital | |
Herlev, Denmark, DN-2730 | |
Fredericia Sygehus | |
Fredericia, Denmark, DN-7000 | |
France | |
CHRU Clémenceau | |
Caen, France, FR-14033 | |
Italy | |
Ospedale San Bortolo | |
Vicenza, Italy, IT-36100 | |
Ospedale civico e benfratelli | |
Palermo, Italy, IT-90127 | |
Netherlands | |
AMC | |
Amsterdam, Netherlands, NL-1105 AZ | |
Spain | |
Hospital Universitario La Paz | |
Madrid, Spain, ES-28046 | |
Fundacion Jimenez Diaz | |
Madrid, Spain, ES-28040 | |
United Kingdom | |
University of Wales College of Medicine | |
Cardiff, United Kingdom, CF 14 4XN | |
Royal Hospital The Royal London | |
London, United Kingdom, E1 1BB | |
The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust | |
Oxford, United Kingdom, OX3 7LJ | |
Milton Keynes General Hospital | |
Milton Keynes, United Kingdom, MK6 5LD | |
Glasgow Western Infirmary | |
Glasgow, United Kingdom, G11 6NT | |
High Wycombe Hospital | |
Buckinghamshire, United Kingdom, HP11 2TT | |
University Hospital ,Queen Elizabeth Hospital | |
Birmingham, United Kingdom, B15 2TH |
Study Director: | Medical Monitor | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | REN00304 |
Study First Received: | September 15, 2005 |
Last Updated: | July 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00196755 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Denmark: Danish Medicines Agency; Belgium: Directorate general for the protection of Public health: Medicines |
Calcium, Dietary Sevelamer Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Chelating Agents Kidney Diseases Calcium acetate Kidney Failure |
Sevelamer Renal Insufficiency Molecular Mechanisms of Pharmacological Action Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Chelating Agents Kidney Diseases Calcium acetate Pharmacologic Actions Kidney Failure |