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Completed

NCT Number: NCT01524601

The Rosuvastatin In TrAnsplant Recipients Study

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.

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Key information

Conditions

Disorder Related to Renal Transplantation Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

20 mg rosuvastatin for 4 weeks

Other names: Crestor

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study 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

Acronym: RITA

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2012
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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