Monitoring Cellular Immunity After Kidney and Liver Transplantation

NCT ID: NCT00683748

Last Updated: 2009-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-03-31

Brief 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.

Conditions

Terminal Kidney Failure; Terminal Liver Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Kidney transplant

No interventions assigned to this group

Liver transplant

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• All patients undergoing kidney or liver transplantation at the Karolinska University Hospital

Exclusion Criteria

• Abscence of informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karolinska University Hospital, Department of Transplantation Surgery

Principal Investigators

Lars Wennberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Gunnar Tyden, MD, PhD

Role: STUDY_DIRECTOR

Karolinska University Hospital

Locations

Lars Wennberg

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

T cell study

Identifier Type: -

Identifier Source: org_study_id