Renal transplant recipients need life long immunosuppression and one of the new drugs is everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects are increased blood cholesterol levels. Many renal transplant recipients are treated with a cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering drug on the market with a potential higher cholesterol lowering potency. In the present study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels more than fluvastatin in renal transplant patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
20 mg rosuvastatin for 4 weeks
Oslo University Hospital, Rikshospitalet
Oslo, Norway
compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin
Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin
Time frame: 4 weeks
Area Under Curve (AUC) of rosuvastatin in renal transplant recipients treated with everolimus. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post dose.
Compare 24-h pharmacokinetics of renal transplant recipients with historic controls
Time frame: 4 weeks
1. Area Under Curve (AUC) of everolimus during rosuvastatin versus fluvastatin therapy, including intracellular everolimus concentrations within T-lymphocytes. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose.
Time frame: 4 weeks
2. Investigate P-gp activity in whole blood in everolimus treated patients
Time frame: 4 weeks
3. Study inter individual variation in rosuvastatin and everolimus pharmacokinetics in renal transplant recipients due to polymorphism in the genes encoding P-gp, OATP1B1 and CYP3A5
Time frame: 4 weeks
4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)
Time frame: 4 weeks
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