Heart Transplantation, Renal Transplantation
Conditions
Keywords
intracellular concentration, cyclosporine A, renal biopsies, heart biopsies, Renal transplant recipients
Brief 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.
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.
Interventions
DRUGCyclosporine A
Sponsors
University of Oslo School of Pharmacy
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rejection | — |
| pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | — |
| genotypes | — |
| metabolites | — |
Countries
Norway
Outcome results
None listed