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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00502242 |
The primary objective of the study is to determine the efficacy of ramipril in preventing a urinary protein to creatinine ratio (U p/c) greater than 0.5 following conversion to sirolimus from a calcineurin inhibitor (CNI) in maintenance kidney transplant patients.
Condition | Intervention | Phase |
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Kidney Transplant Kidney Transplantation Renal Transplant |
Drug: sirolimus Drug: ramipril |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating the Effect of Ramipril On Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus |
Estimated Enrollment: | 375 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental | Drug: sirolimus |
B: Active Comparator | Drug: ramipril |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Additional Inclusion / Exclusion Criteria apply.
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0468E5-4439 |
Study First Received: | July 16, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00502242 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Sirolimus Immunologic Factors Clotrimazole Miconazole Tioconazole Cardiovascular Agents Antihypertensive Agents |
Immunosuppressive Agents Ramipril Protease Inhibitors Anti-Bacterial Agents Antifungal Agents Angiotensin-Converting Enzyme Inhibitors |
Sirolimus Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents |
Antibiotics, Antineoplastic Immunosuppressive Agents Ramipril Pharmacologic Actions Protease Inhibitors Anti-Bacterial Agents Therapeutic Uses Antifungal Agents Angiotensin-Converting Enzyme Inhibitors |