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

Liver Transplantation Clinical Trial

— OSCITT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01065584
• Other study ID #: OSCITT10
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2010
• Last updated: September 14, 2011
• Start date: February 2010
• Est. completion date: April 2012

Study information

• Verified date: September 2011
• Source: University Medical Center Goettingen
• Contact: Aiman Obed, Prof. Dr.
• Phone: +49 551 3912296
• Email: aobed[@]chirurgie-goettingen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Transplantation

Locations

Country	Name	City	State
Germany	University Medical Center Goettingen	Goettingen	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Goettingen

Country where clinical trial is conducted

Germany,