A Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation
This is a prospective, multicenter open-label single arm trial in which recipients of liver allograft will receive uniform immunosuppressive induction and maintenance regimens. Participants with end stage liver disease who meets the entry criteria will be consented and enrolled.
Participants receive Campath-1H and maintenance immunosuppression with tacrolimus therapy. After one year of tacrolimus therapy, an assessment of the immunologic status including blood gene expression and geno-race studies will be performed which will include studies on the liver graft biopsy. At this time, patients will be selected to undergo immunosuppressive withdrawal. This will be made on an individual basis with definitive inclusion and exclusion criteria.
The objectives of the study are to evaluate the safety and efficacy of immunosuppressive regimens comprising Campath-1H induction followed by maintenance immunosuppressive therapy with tacrolimus on allograft survival. However, secondary objectives will be to assess withdrawing tacrolimus after Campath-1H induction in an immune depletion and subsequent immune reconstitution. This study will evaluate whether a combination of anti-rejection medications (Campath-1H and tacrolimus) can prevent rejection and allow the body to develop tolerance to the transplanted liver.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thistlethwaite Protocol # ITN025ST - Immunosuppression With Campath-1H and Tacrolimus in Liver Transplantation|
- To evaluate the safety and efficacy of an immunosuppression regimen comprising Campath-1H induction followed by maintenance therapy with tacrolimus in allowing liver allograft survival
- Assess the safety of withdrawing tacrolimus after Campath-1H induced immuno-depletion and subsequent immune reconstitution
- Gather additional safety information about the combination of Campath-1H and tacrolimus in liver allograft recipients
- Define profiles of immunologic and genetic features present prior to or during tapering of immunosuppression that distinguish tolerant and non tolerant allograft recipients
|Study Start Date:||January 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166556
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Russell H. Wiesner, M.D.||Mayo Clinic|