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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 fluvastatin

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.

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

Page last updated: August 23, 2015

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