Status:
COMPLETED
The Rosuvastatin In TrAnsplant Recipients Study
Lead Sponsor:
University of Oslo School of Pharmacy
Collaborating Sponsors:
Oslo University Hospital
Conditions:
Disorder Related to Renal Transplantation
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01524601
Start Date
February 1 2012
End Date
October 1 2012
Last Update
October 12 2012
Active Locations (1)
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1
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0027