To determine the effect of conversion from calcineurin inhibitor to sirolimus (Rapamune) treatment on kidney function. This study will also evaluate the safety and efficacy of the conversion of therapies.
– Liver Transplantation- Hepatic Transplantation
Treatment, Randomized, Open Label, Safety/Efficacy Study
Eligibility & Criteria
Criteria Inclusion Criteria:- Male/Female Age ≥13 years and weight ≥ 40 kg. – Women of childbearing potential must have a negative serum pregnancy test result before random assignment and must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of randomly assigned treatment. Any woman becoming pregnant during the treatment period must withdraw from the study. – Subjects receiving immunosuppressive therapy with a CI with or without a CS or with or without antimetabolite therapy for a minimum of 4 weeks before random assignment. – Six (6) to 120 months after orthotopic liver transplantation. – Cockcroft-Gault GFR values ≥ 40 mL/min and ≤90 mL/min at screening. – Written, signed, and dated IRB- or IEC-approved informed consent (subjects younger than the legal age of consent will sign an assent form, but a parent or legal guardian must provide written permission). Exclusion Criteria:- History of nonhepatic transplantation. – Biopsy-confirmed acute rejection within 8 weeks of randomization or (1 year before randomization if severe). – Dialysis in the 2 weeks prior to randomization. – History of documented human immunodeficiency virus infection. – History of deep vein thrombosis, hepatic artery thrombosis, hepatic vein thrombosis or portal vein thrombosis.
Princess Alexandra Hospital, Wooloongabba, Queensland, 4102, Australia; Recruiting Jonathan Fawcett, Pr + 617 3240 2385