The Rosuvastatin In TrAnsplant Recipients Study
Information source: University of Oslo School of Pharmacy
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Disorder Related to Renal Transplantation; Hypercholesterolemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Oslo School of Pharmacy Official(s) and/or principal investigator(s): Anders Åsberg, PhD, Study Director, Affiliation: University of Oslo
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.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatinArea 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.
Secondary outcome: 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.2. Investigate P-gp activity in whole blood in everolimus treated patients 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 4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Oslo University Hospital, Rikshospitalet, Oslo 0027, Norway
Additional Information
Starting date: February 2012
Last updated: October 11, 2012
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