The Rosuvastatin In TrAnsplant Recipients Study

Hypercholesterolemia Clinical Trial

— RITA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524601
• Other study ID #: RITA-11
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2012
• Last updated: October 11, 2012
• Start date: February 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder Related to Renal Transplantation
• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin
20 mg rosuvastatin for 4 weeks

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin	Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin	4 weeks	No
Primary	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.	Compare 24-h pharmacokinetics of renal transplant recipients with historic controls	4 weeks	Yes
Secondary	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	Yes
Secondary	2. Investigate P-gp activity in whole blood in everolimus treated patients		4 weeks	No
Secondary	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	No
Secondary	4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)		4 weeks	Yes