Induction Treatment Followed by Immunosuppression Withdrawal in Liver Transplantation: A Comparative Trial

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, controlled trial in liver transplantation in which conventional immunosuppressive treatment will be compared with a therapeutic strategy consisting in pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor minimization may promote development of tolerogenic mechanisms allowing the eventual withdrawal of all immunosuppressive therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Collaborators: Astellas Pharma Inc; Fresenius AG
• Treatments: Antilymphocyte Serum; Immunoglobulins; Tacrolimus

Criteria

Inclusion Criteria:

• Age > 18 years

• Recipient of a primary liver graft

• Absence of any of our exclusion criteria

Exclusion Criteria:

• Pretransplant renal failure, defined as serum creatinine > 1.5 mg/dL

• Severe pretransplant thrombopenia, defined as platelets < 50000/mL

• Combined liver-kidney transplantation

• Autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis as causes of liver transplantation

• Chronic hepatic encephalopathy

• Living donor liver transplantation

• Recipient with human immunodeficiency virus infection

• Severe pretransplant leukopenia, defined as < 1500 leukocytes/mL