The Rosuvastatin In TrAnsplant Recipients Study

Phase 4

Completed

• Conditions: Disorder Related to Renal Transplantation; Hypercholesterolemia
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01524601
• Lead Sponsor: University of Oslo School of Pharmacy

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-24
• Study Start: 2012-02
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-02
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-11
• Last Update Posted: 2012-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	Rosuvastatin treatment for 4 weeks

Primary Outcome Measures

Name	Time	Method
compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin	4 weeks	Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin
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.	4 weeks	Compare 24-h pharmacokinetics of renal transplant recipients with historic controls

Secondary Outcome Measures

Name	Time	Method
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.	4 weeks
2. Investigate P-gp activity in whole blood in everolimus treated patients	4 weeks
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 weeks
4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)	4 weeks

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway