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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00311311 |
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.
Condition | Intervention | Phase |
---|---|---|
Atherosclerosis Kidney Failure |
Drug: tacrolimus Drug: sirolimus Drug: mycophenolate mofetil Drug: prednisone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Prospective, Randomized, Open-Label, Pilot Study to Compare the Effect on Carotid Atherosclerosis of a Tacrolimus-Based Regimen With Conversion From a Tacrolimus- to a Sirolimus-Based Regimen at 3-4 Months Post-Transplant in De Novo Renal Transplant Recipients |
Estimated Enrollment: | 100 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2012 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator | Drug: tacrolimus Drug: mycophenolate mofetil Drug: prednisone |
2: Experimental | Drug: sirolimus |
Ages Eligible for Study: | 35 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following characteristics:
Exclusion Criteria:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
United States, New York | |
Recruiting | |
Rochester, New York, United States, 14642 | |
Canada, Alberta | |
Recruiting | |
Edmonton, Alberta, Canada, T6G 2G3 | |
Recruiting | |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, Ontario | |
Not yet recruiting | |
Toronto, Ontario, Canada, M5C 2T2 | |
Recruiting | |
Hamilton, Ontario, Canada, L8N 4A6 | |
Recruiting | |
London, Ontario, Canada, N6A 5A5 | |
Canada, Quebec | |
Recruiting | |
Montreal, Quebec, Canada, H1T-2M4 |
Principal Investigator: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0468H1-101995 |
Study First Received: | April 3, 2006 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00311311 |
Health Authority: | Canada: Health Canada |
Kidney transplant Renal transplant Immunosuppression |
Atherosclerosis Graft Rejection Kidney Transplant |
Atherosclerosis Arterial Occlusive Diseases Sirolimus Prednisone Renal Insufficiency Clotrimazole Miconazole Tioconazole |
Vascular Diseases Arteriosclerosis Tacrolimus Urologic Diseases Mycophenolate mofetil Kidney Diseases Kidney Failure |
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antibiotics, Antineoplastic |
Immunosuppressive Agents Glucocorticoids Hormones Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Antifungal Agents Cardiovascular Diseases |