drugset / Trial / NCT00188955

Pilot Study on the Use of Sirolimus to Treat Chronic Allograft Nephropathy in Children After Kidney Transplant

NCT00188955

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2004-03
Primary completion
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule 1 mg/m2 Oral

Indications

No indication recorded.