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

University Medical Center Goettingen

Status

Unknown

Conditions

Liver Transplantation

Study type

Observational

Funder types

Other

Identifiers

NCT01065584

OSCITT10

Details and patient eligibility

About

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.

Enrollment

58 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)