- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683748
Monitoring Cellular Immunity After Kidney and Liver Transplantation
February 4, 2009 updated by: Karolinska University Hospital
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Stockholm, Sweden, 14186
- Lars Wennberg
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients undergoing kidney or liver transplantation at the Karolinska University Hospital
Description
Inclusion Criteria:
- All patients undergoing kidney or liver transplantation at the Karolinska University Hospital
Exclusion Criteria:
- Abscence of informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Kidney transplant
|
Liver transplant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
T cell reactivity to viral antigens
Time Frame: Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation
|
Pre-transplantation and 2 weeks, 1, 3, 6 and 12 months after transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gunnar Tyden, MD, PhD, Karolinska University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Anticipated)
March 1, 2009
Study Completion (Anticipated)
March 1, 2009
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 21, 2008
First Posted (Estimate)
May 23, 2008
Study Record Updates
Last Update Posted (Estimate)
February 5, 2009
Last Update Submitted That Met QC Criteria
February 4, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T cell study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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