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Sponsors and Collaborators: |
Karolinska University Hospital Uppsala University Hospital |
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Information provided by: | Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT00683748 |
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.
Condition |
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Terminal Kidney Failure Terminal Liver Failure |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Monitoring Cellular Immunity After Kidney and Liver Transplantation |
Serum, whole blood
Estimated Enrollment: | 100 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Kidney transplant |
Liver transplant |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All patients undergoing kidney or liver transplantation at the Karolinska University Hospital
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Lars Wennberg | |
Stockholm, Sweden, 14186 |
Principal Investigator: | Lars Wennberg, MD, PhD | Karolinska University Hospital |
Study Director: | Gunnar Tyden, MD, PhD | Karolinska University Hospital |
Responsible Party: | Karolinska University Hospital, Department of Transplantation Surgery ( Lars Wennberg, Associate Professor ) |
Study ID Numbers: | T cell study |
Study First Received: | May 21, 2008 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00683748 History of Changes |
Health Authority: | Sweden: Institutional Review Board |
Transplantation Immunological monitoring Immunological risk T cell reactivity Cellular immunity |
Liver Failure Liver Diseases Renal Insufficiency Digestive System Diseases |
Urologic Diseases Kidney Diseases Hepatic Insufficiency Kidney Failure |
Liver Failure Liver Diseases Renal Insufficiency Digestive System Diseases |
Urologic Diseases Kidney Diseases Hepatic Insufficiency Kidney Failure |