Pilot Study on the Use of Sirolimus to Treat Chronic Allograft Nephropathy in Children After Kidney Transplant
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|ClinicalTrials.gov Identifier: NCT00188955|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 22, 2010
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 or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: sirolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||October 2008|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188955
|Winnipeg, Manitoba, Canada, R3A 1S1|
|Principal Investigator:||Tom D. Blydt-Hansen, MD||University of Manitoba, Manitoba Institute of Child Health|