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The Rosuvastatin In TrAnsplant Recipients Study (RITA)

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ClinicalTrials.gov Identifier: NCT01524601
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : October 12, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Hypercholesterolemia Drug: Rosuvastatin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: Rosuvastatin
Rosuvastatin treatment for 4 weeks
Drug: Rosuvastatin
20 mg rosuvastatin for 4 weeks
Other Name: Crestor


Outcome Measures

Primary Outcome Measures :
  1. compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin [ Time Frame: 4 weeks ]
    Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin

  2. 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. [ Time Frame: 4 weeks ]
    Compare 24-h pharmacokinetics of renal transplant recipients with historic controls


Secondary Outcome Measures :
  1. 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. [ Time Frame: 4 weeks ]
  2. 2. Investigate P-gp activity in whole blood in everolimus treated patients [ Time Frame: 4 weeks ]
  3. 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 [ Time Frame: 4 weeks ]
  4. 4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR) [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524601


Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Oslo University Hospital
Investigators
Study Director: Anders Åsberg, PhD University of Oslo
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier: NCT01524601     History of Changes
Other Study ID Numbers: RITA-11
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012

Keywords provided by University of Oslo School of Pharmacy:
Immunosuppression
Everolimus
rosuvastatin
fluvastatin
Lipid lowering

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Everolimus
Rosuvastatin Calcium
Fluvastatin
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors