A Screening Study for Identification of Tolerance Markers in Liver Transplant Recipients Who Received Campath-1H Immunosuppression

Principal Investigator

Andreas Tzakis, MD | Jackson Memorial Hospital | Miami, FL

Panagiotis Tryphonopoulos, MD | University of Miami | Miami, FL

Locations

Jackson Memorial Hospital | Miami, FL

Study Code

ITN816AS

Study Status

Completed

Abstract

Advances in the development of immunosuppressive medications have allowed for a long-term survival of liver and intestinal transplant recipients. After transplantation, patients are routinely given immunosuppressive medications to help prevent rejection of their transplanted organ. Despite this practice, some patients still experience organ rejection, whereas others develop stable graft function. The reason for this difference is unknown, as there is little clinical data to determine which patients will develop stable graft functions after transplantation.

Recent research has shown that unique genotypes are found in liver or kidney transplant recipients who have withdrawn from immunosuppression medication after transplantation. We aim to identify which study participants - all of whom previously received a liver transplant under Campath-1H immunosuppression - exhibit specific tolerogenic genotypes. Our hypothesis is that patients who exhibit these genotypes might be good candidates for future immunosuppression withdrawal.

The study will enroll 100 patients. There will be only one study visit, during which a blood sample will be drawn from each participant for use in tolerance assays. The visit will occur concurrently with the participant's outpatient visit for standard medical care.

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