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Monitoring Cellular Immunity After Kidney and Liver Transplantation
This study is ongoing, but not recruiting participants.
First Received: May 21, 2008   Last Updated: February 4, 2009   History of Changes
Sponsors and Collaborators: Karolinska University Hospital
Uppsala University Hospital
Information provided by: Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT00683748
  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

MedlinePlus related topics: Kidney Failure Liver Transplantation
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Monitoring Cellular Immunity After Kidney and Liver Transplantation

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

Biospecimen Description:

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
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: 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

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

Study placed in the following topic categories:
Liver Failure
Liver Diseases
Renal Insufficiency
Digestive System Diseases
Urologic Diseases
Kidney Diseases
Hepatic Insufficiency
Kidney Failure

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

ClinicalTrials.gov processed this record on May 07, 2009