NCT01065584

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 58 (estimated)
• Sponsor: University Medical Center Goettingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2010-02-09
• Last updated: 2011-09-15

Locations

1 site across 1 country: Germany