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The Rosuvastatin In TrAnsplant Recipients Study

NCT ID: NCT01524601

Last Updated: 2012-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

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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

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Conditions

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Disorder Related to Renal Transplantation Hypercholesterolemia

Keywords

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Immunosuppression Everolimus rosuvastatin fluvastatin Lipid lowering

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin

Rosuvastatin treatment for 4 weeks

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

20 mg rosuvastatin for 4 weeks

Interventions

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Rosuvastatin

20 mg rosuvastatin for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo School of Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Åsberg, PhD

Role: STUDY_DIRECTOR

University of Oslo

Locations

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Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 24521776 (View on PubMed)

Other Identifiers

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RITA-11

Identifier Type: -

Identifier Source: org_study_id