Overview

This trial is active, not recruiting.

Conditions terminal kidney failure, terminal liver failure
Sponsor Karolinska University Hospital
Collaborator Uppsala University Hospital
Start date March 2007
End date March 2009
Trial size 100 participants
Trial identifier NCT00683748, T cell study

Summary

After transplantation, if insufficient immunosuppression is achieved, rejection and graft loss follows. If to much immunosuppression is given, the patient suffers risk for infections and malignancies. Despite careful dosing and monitoring of drug levels, the biological effects of the immunosuppression given is difficult to predict and varies significantly. As a result, the degree of immunosuppression (or immunosuppressive status) remains unknown and clinical problems related to under- or over-immunosuppression are common. Thus, a method to determine the degree of immunosuppression would be of great and direct clinical importance and the results would be improved. T cells are the principal cells of the immunesystem causing rejection. Furthermore, all immunosuppressive regimes targets T cells. Thus, T cell reactivity could reflect the biological effects of the immunosuppression and the immunosuppressive status. In addition, T cells are of crucial importance in the immunedefence against viral diseases. Therefore, data on virus specific T cell reactivity could aid in diagnosis, monitoring and treatment of viral disease. The proposed study aim to develop a clinically useful method to monitor cellular immunity and the degree of immunosuppression after transplantation by determinations of the specific T cell reactivity to several clinically relevant viruses.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm

Primary Outcomes

Measure
T cell reactivity to viral antigens
time frame: Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients undergoing kidney or liver transplantation at the Karolinska University Hospital Exclusion Criteria: - Abscence of informed consent

Additional Information

Official title Monitoring Cellular Immunity After Kidney and Liver Transplantation
Principal investigator Lars Wennberg, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.