Pilot Study on the Use of Sirolimus to Treat Chronic Allograft Nephropathy in Children After Kidney Transplant
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- histological quantification of interstitial fibrosis at 2 years
- Renal function at 1 and 2 years.
- Proteinuria at 2 years.
- Freedom from acute rejection and graft loss over the 2 year study period.
- Cumulative incidence and prevalence of adverse events and serious adverse events over the 2-year study period.
|Study Start Date:||March 2004|
|Study Completion Date:||October 2008|
|Winnipeg, Manitoba, Canada, R3A 1S1|
|Principal Investigator:||Tom D. Blydt-Hansen, MD||University of Manitoba, Manitoba Institute of Child Health|