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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:
Oslo University Hospital
Information provided by (Responsible Party):
University of Oslo School of Pharmacy

Tracking Information
First Submitted Date  ICMJE January 24, 2012
First Posted Date  ICMJE February 2, 2012
Last Update Posted Date October 12, 2012
Study Start Date  ICMJE February 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01524601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • 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. Investigate P-gp activity in whole blood in everolimus treated patients [ Time Frame: 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 [ Time Frame: 4 weeks ]
  • 4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR) [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Rosuvastatin In TrAnsplant Recipients Study
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Disorder Related to Renal Transplantation
  • Hypercholesterolemia
Intervention  ICMJE Drug: Rosuvastatin
20 mg rosuvastatin for 4 weeks
Other Name: Crestor
Study Arms  ICMJE Experimental: Rosuvastatin
Rosuvastatin treatment for 4 weeks
Intervention: Drug: Rosuvastatin
Publications * Robertsen I, Asberg A, Granseth T, Vethe NT, Akhlaghi F, Ghareeb M, Molden E, Reier-Nilsen M, Holdaas H, Midtvedt K. More potent lipid-lowering effect by rosuvastatin compared with fluvastatin in everolimus-treated renal transplant recipients. Transplantation. 2014 Jun 27;97(12):1266-71. doi: 10.1097/01.TP.0000443225.66960.7e.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01524601
Other Study ID Numbers  ICMJE RITA-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oslo School of Pharmacy
Study Sponsor  ICMJE University of Oslo School of Pharmacy
Collaborators  ICMJE Oslo University Hospital
Investigators  ICMJE
Study Director: Anders Åsberg, PhD University of Oslo
PRS Account University of Oslo School of Pharmacy
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP