The Rosuvastatin In TrAnsplant Recipients Study

The RITA-study -- An Open Study to Evaluate the Blood Lipid Lowering Effect of Rosuvastatin Versus Fluvastatin and the Bilateral Interaction Between Everolimus and Rosuvastatin in Renal Transplant Recipients

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.

Inclusion Criteria:

• Renal transplant recipients with stable renal function (plasma creatinine < 200 µmol/L)
• Renal transplant recipients on an everolimus and fluvastatin based therapy for minimum 3 months prior to inclusion
• > 18 years of age
• Male patient or female patient without childbearing potential (surgically sterilized or postmenopausal) or if female of childbearing potential; is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of the study drugs
• Signed informed consent

Exclusion Criteria:

• Patients experiencing an acute rejection episode within 2 weeks before or after inclusion, whether proven by biopsy or not
• Patients with a known hypersensitivity to rosuvastatin
• Change in enzyme inducing or inhibiting drugs within the last 2 weeks prior to and throughout the study [e.g. barbiturates, rifampicin, ketoconazole, erythromycin, cimetidine and similar drugs]
• Pregnant or nursing mothers