Monitoring Cellular Immunity After Kidney and Liver Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Karolinska University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Uppsala University Hospital
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00683748
First received: May 21, 2008
Last updated: February 4, 2009
Last verified: February 2009
  Purpose

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
Terminal Kidney Failure
Terminal Liver Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring Cellular Immunity After Kidney and Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • T cell reactivity to viral antigens [ Time Frame: Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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
Kidney transplant
Liver transplant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Abscence of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683748

Locations
Sweden
Lars Wennberg
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Uppsala University Hospital
Investigators
Principal Investigator: Lars Wennberg, MD, PhD Karolinska University Hospital
Study Director: Gunnar Tyden, MD, PhD Karolinska University Hospital
  More Information

No publications provided

Responsible Party: Lars Wennberg, Associate Professor, Karolinska University Hospital, Department of Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00683748     History of Changes
Other Study ID Numbers: T cell study
Study First Received: May 21, 2008
Last Updated: February 4, 2009
Health Authority: Sweden: Institutional Review Board

Keywords provided by Karolinska University Hospital:
Transplantation
Immunological monitoring
Immunological risk
T cell reactivity
Cellular immunity

Additional relevant MeSH terms:
Renal Insufficiency
Liver Failure
Kidney Diseases
Urologic Diseases
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 31, 2014