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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01065584

Acronym

OSCITT

Enrollment

Registered

2010-02-09

Start date

2010-02-28

Completion date

2012-04-30

Last updated

2011-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

liver transplantation, Patients undergoing liver transplantation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Countries

Germany

Contacts

Primary ContactAiman Obed, Prof. Dr.

aobed@chirurgie-goettingen.de+49 551 3912296

Backup ContactArmin D Goralczyk, Dr.

agoralczyk@med.uni-goettingen.de+49 551 3914638

Outcome results