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Sponsors and Collaborators: |
University of Manitoba Wyeth |
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Information provided by: | University of Manitoba |
ClinicalTrials.gov Identifier: | NCT00188955 |
The purpose of this study is to determine whether treatment with sirolimus, in combination with low-dose tacrolimus and prednisone, is effective for the treatment of chronic allograft nephropathy (progressive scarring) in children who have previously received a kidney transplant. This treatment is compared to the standard therapy which uses low-dose tacrolimus, mycophenolate mofetil and prednisons.
This study is a pilot study that will determine whether treatment with sirolimus reduces or improves the rate of scarring seen on kidney biopsy of the transplanted kidney over time, compared to children who continue to be treated with mycophenolate mofetil.
Condition | Intervention | Phase |
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Kidney Transplantation |
Drug: sirolimus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 4 Randomized, Controlled Study Comparing Sirolimus and Mycophenolate Mofetil to Prevent or Reverse Progression in Pediatric Renal Transplants With Chronic Allograft Nephropathy |
Estimated Enrollment: | 40 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | October 2008 |
Ages Eligible for Study: | 6 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Manitoba | |
Children's Hospital | |
Winnipeg, Manitoba, Canada, R3A 1S1 |
Principal Investigator: | Tom D. Blydt-Hansen, MD | University of Manitoba, Manitoba Institute of Child Health |
Study ID Numbers: | WINNIPEG-CAN-1 |
Study First Received: | September 10, 2005 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00188955 |
Health Authority: | Canada: Health Canada |
pediatric chronic allograft nephropathy chronic rejection interstitial fibrosis |
Sirolimus Urologic Diseases Clotrimazole Fibrosis Miconazole |
Tioconazole Mycophenolate mofetil Disease Progression Kidney Diseases |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |