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NCT00139009 Clinical Trial

Intracellular and Renal/Myocardial Tissue Concentrations of Cyclosporine A (CsA) and Rejection Frequency Following Transplantation

Renal Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139009
Other study ID # SUPER-CsA
Secondary ID
Status Completed
Phase Phase 4
First received August 29, 2005
Last updated June 14, 2007
Start date June 2005
Est. completion date September 2006

Study information
Verified date September 2006
Source University of Oslo School of Pharmacy
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Renal or heart transplant recipients scheduled to receive CsA as part of their immunosuppressive therapy at the time of transplantation.

2. 18 years of age or older.

3. Signed informed consent.

Exclusion Criteria:

1. Known contraindications for renal or heart biopsies, respectively, at the time of inclusion.

2. Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepine, fluconazole, ketoconazole, erythromycin, clarithromycin.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclosporine A

Locations
Country Name City State
Norway Rikshospitalet, Section of Nephrology Oslo

Sponsors (1)
Lead Sponsor Collaborator
University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary rejection
Primary pharmacokinetics
Secondary toxicity
Secondary genotypes
Secondary metabolites
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