The Rosuvastatin In TrAnsplant Recipients Study (RITA)

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT01524601
First received: January 24, 2012
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Disorder Related to Renal Transplantation
Hypercholesterolemia
Drug: Rosuvastatin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Compare 24-h pharmacokinetics of renal transplant recipients with historic controls


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 2. Investigate P-gp activity in whole blood in everolimus treated patients [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin
Rosuvastatin treatment for 4 weeks
Drug: Rosuvastatin
20 mg rosuvastatin for 4 weeks
Other Name: Crestor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Oslo School of Pharmacy

Additional 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
Study First Received: January 24, 2012
Last Updated: October 11, 2012
Health Authority: Norway: Norwegian Medicines Agency

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
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014