- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00139009
Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary objective is to investigate intralymphocyte concentrations of CsA in renal and heart transplant recipients to elucidate the association between the intracellular concentration and efficacy (rejection episodes and histology) in transplanted patients on CsA based immunosuppressive therapy.
Secondary objectives are to investigate associations between intralymphocyte concentrations and whole-blood concentrations of CsA, renal tissue concentrations and nephrotoxicity, heart tissue concentrations and cardiotoxicity with CsA based immunosuppressive therapy in transplanted patients. In addition, this study aims to validate the use of quinine as a probe for determination of CYP3A4 activity in transplanted patients as well as proteomic-based urine analyses as a screening tool for acute rejection episodes in transplanted patients.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Oslo, Norway, 0027
- Rikshospitalet, Section of Nephrology
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation.
- 18 years of age or older.
- Signed informed consent.
Exclusion Criteria:
- Known contraindications for renal or heart biopsies, respectively, at the time of inclusion.
- Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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rejection
|
pharmacokinetics
|
Secondary Outcome Measures
Outcome Measure |
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toxicity
|
genotypes
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metabolites
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Collaborators and Investigators
Investigators
- Study Director: Anders Åsberg, MSc, University of Oslo
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUPER-CsA
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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