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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard immunosuppression

Patients receiving standard immunosuppression after liver transplantation including calcineurininhibitors

No interventions assigned to this group

Immunosuppression without calcineurininhibitors

Patients receiving immunosuppression after liver transplantation not based on calcineurininhibitors

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No