Status:
COMPLETED
Is T-lymphocyte Calcineurin Phosphatase Up-regulated by Treatment With Tacrolimus?
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Danish Society of Nephrology
The Danish Kidney Association
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this study is to determine whether calcineurin phosphatase in the T-lymphocytes is up-regulated after long-term treatment with tacrolimus, a calcineurin inhibitor.
Detailed Description
Background: The immunosuppressive effect of both tacrolimus and cyclosporine is believed to be through inhibition of the enzyme calcineurin phosphatase (CaN) in T-lymphocytes. We have demonstrated, t...
Eligibility Criteria
Inclusion
- Group 1 (early kidney-transplant recipients)
- Age over 18 years
- 20 consecutively kidney-transplant recipients at Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
- receiving tacrolimus as part of their immunosuppressive treatment
- receipt of graft from either deceased or living-related donor
- written consent to participate
- Group 2 (stable kidney-transplant recipients)
- Age over 18 years
- Stable renal allograft function defined as S-creatinine \<200 µmol/l
- variation in S-creatinine \<20% for 6 months prior to inclusion
- kidney transplantation more than 2 years before inclusion
- receipt of graft from either deceased or living-related donor
- written consent to participate
Exclusion
- Group 1 (early kidney-transplant recipients)
- patients suspected of non-compliance
- patients receiving medications known to interact with tacrolimus pharmacokinetics
- patients who on day 8 after transplantation have not reached a trough level for blood tacrolimus concentration above 8 µg/l.
- Group 2 (stable kidney-transplant recipients)
- patients suspected of non-compliance
- patients receiving medications known to interact with tacrolimus pharmacokinetics
Key Trial Info
Start Date :
October 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00999362
Start Date
October 1 2007
End Date
October 1 2009
Last Update
October 21 2009
Active Locations (1)
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1
Department of Nephrology, Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200