Overview

The Rosuvastatin In TrAnsplant Recipients Study

Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Oslo School of Pharmacy
Collaborator:
Oslo University Hospital
Treatments:
Everolimus
Fluvastatin
Rosuvastatin Calcium
Criteria
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