|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| ClinicalTrials.gov Identifier: | NCT00196755 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
1: Experimental
sevelamer hydrochloride
|
Drug: Sevelamer Hydrochloride (Renagel®)
Sevelamer hydrochloride three times per day with each meal
|
|
2: Active Comparator
Calcium acetate
|
Drug: Calcium acetate (PhosLo® )
Calcium acetate three times per day with each meal
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 |
|
Renal Insufficiency Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Kidney Failure, Chronic Bone Density Conservation Agents Calcium acetate Pharmacologic Actions |
Calcium, Dietary Sevelamer Urologic Diseases Renal Insufficiency, Chronic Kidney Diseases Chelating Agents Kidney Failure |