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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 |
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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 History of Changes |
Health Authority: | Canada: Health Canada |
Kidney transplant Renal transplant Immunosuppression |
Atherosclerosis Graft Rejection Kidney Transplant |
Sirolimus Atherosclerosis Anti-Inflammatory Agents Prednisone Renal Insufficiency Immunologic Factors Clotrimazole Hormone Antagonists Miconazole Hormones, Hormone Substitutes, and Hormone Antagonists Tacrolimus Arteriosclerosis Hormones |
Anti-Bacterial Agents Urologic Diseases Antifungal Agents Mycophenolate mofetil Kidney Diseases Arterial Occlusive Diseases Antineoplastic Agents, Hormonal Vascular Diseases Tioconazole Glucocorticoids Immunosuppressive Agents Kidney Failure |
Sirolimus Atherosclerosis Anti-Inflammatory Agents Prednisone Anti-Infective Agents Renal Insufficiency Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Tacrolimus Arteriosclerosis Antibiotics, Antineoplastic Hormones |
Anti-Bacterial Agents Urologic Diseases Therapeutic Uses Antifungal Agents Mycophenolate mofetil Cardiovascular Diseases Kidney Diseases Arterial Occlusive Diseases Antineoplastic Agents, Hormonal Vascular Diseases Immunosuppressive Agents Glucocorticoids Pharmacologic Actions Kidney Failure |