A Randomized, Open-Label, Comparative Evaluation Of Conversion From Calcineurin Inhibitor Treatment To Sirolimus (Rapamune) Treatment versus Continued Calcineurin Inhibitor Treatment In Liver Allograft Recipients Undergoing Maintenance Therapy

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.

Official Title

Conditions

– Liver Transplantation- Hepatic Transplantation

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Safety/Efficacy Study

Further Details

Study Start

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.

Total Enrolment

Contact Details

Princess Alexandra Hospital, Wooloongabba, Queensland, 4102, Australia; Recruiting Jonathan Fawcett, Pr + 617 3240 2385