Liver Immunosuppression Free Trial (
Research type
Research Study
Full title
Prospective randomised marker-based trial to assess the clinical utility and safety of biomarker-guided immunosuppression withdrawal in liver transplantation ("LIFT" Trial).
IRAS ID
126037
Contact name
Alberto Sanchez-Fueyo
Contact email
Sponsor organisation
King's College London
Eudract number
2014-004557-14
Research summary
Following liver transplantation patients need to receive powerful drugs (known as immunosuppressive medication), to prevent rejection. These drugs are usually administered lifelong, which results in important side effects. This the main reason why in the long run transplanted patients die more frequently than non-transplanted healthy individuals. Not all liver transplant patients, however, require lifelong immunosuppressive medication. Some of them develop a phenomenon known as operational tolerance and can discontinue this medication without rejecting. In tolerant patients the withdrawal of anti-rejection medication could increase their survival and improve their quality of life. However, until now there have been no tests to identify tolerant patients before immunosuppression is discontinued.
Our research group recently identified a genetic test of tolerance in liver biopsies that can predict the outcome of immunosuppressive drug withdrawal. This test could radically change the long-term care of liver transplant patients. The objective of the current project is to determine if this test can be employed to optimize immunosuppression withdrawal, so that withdrawal is only performed in patients who have developed tolerance. To do so, liver transplant patients will undergo a liver biopsy to conduct the genetic test of tolerance. Patients will then be randomly allocated to 2 different strategies. Patients randomized to Arm A will be offered drug withdrawal regardless of the result of the genetic test. Patients randomized to Arm B will undergo drug withdrawal if the genetic test is positive, and will continue the immunosuppressive medication if the test is negative. By comparing the outcome of the 2 strategies we will determine how much the test can benefit transplanted patients. 148 transplanted patients will be enrolled in 11 Liver Transplant Units. Drugs will be discontinued over 6-9 months, following which patients will be followed for 3 additional years. Total study duration will be 72 months.REC name
London - South East Research Ethics Committee
REC reference
14/LO/2172
Date of REC Opinion
9 Feb 2015
REC opinion
Further Information Favourable Opinion