An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance

University Medical Center Goettingen58 enrolled

Overview

In experimental and clinical settings it has been shown that transplant tolerance is possible. It has been suggested that regulatory T cells play a beneficial role in the establishment of tolerance. Calcineurin inhibitors may inhibit development of regulatory T cells. However, the influence of calcineurin inhibitors on markers of transplant tolerance has not been studied in patients undergoing liver transplantation. Currently the investigators conduct a study to evaluate the safety and efficacy of a calcineurin inhibitor free immunosuppression in patients undergoing liver transplantation. In this study measurements of immune function and CD4+CD25high-Foxp3+-Il2/CD8+ status will also be performed. In parallel these measurements should be compared to a group of patients undergoing standard immunosuppression including calcineurin inhibitors.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Transplantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing primary liver transplantation * Patients of age 18 years and older * Female patients of childbearing potential willing to perform a highly effective contraception during the study and 12 weeks after conclusion of study participation Exclusion Criteria: * Multiple organ graft recipients * Patients receiving ABO incompatible grafts * Patients with positive cross match * Pregnancy * Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule * Patients under guardianship (e.g. individuals who are not able to freely give their informed consent)

An Observational Study to Assess the Effect of Calcineurin Inhibitors on Markers of Transplant Tolerance

Overview

Conditions

Eligibility

Locations (1)

Central Contacts