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

Inclusion Criteria: * All male or female patients aged less than 17 years. * The patient has undergone a kidney transplant, from a cadaveric or living donor with compatible ABO blood type. * The patient is more than 12 months post-transplantation. * The allograft demonstrates histological changes consistent with CAN according to the Banff 97 classification schema (minimum of ct1 and ci1 score for tubular atrophy and interstitial fibrosis respectively). Exclusion Criteria: * The patient, or in case the patient is minor, the patient's parent(s) or their legal representative, has been fully informed and will not give informed consent to participate in the study. * The allograft demonstrates histological changes at the time of enrollment consistent with acute allograft rejection Grade Ia or worse, according to the Banff 97 classification schema (minimum of t2 and i2 score for tubulitis and interstitial inflammation respectively). * The patient is known to be allergic or intolerant to MMF, sirolimus or any of their known metabolites. * The patient for who routine protocol kidney biopsy is contraindicated. * Patients whose maintenance immunosuppression does not include both tacrolimus and prednisone at the time on study enrollment. * Patients previously treated with sirolimus. * The patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation. * The patient and/or donor is known to be HIV or HCV positive. …