NCT01524601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 12, 2012

Status Verified

October 1, 2012

Enrollment Period

8 months

First QC Date

January 24, 2012

Last Update Submit

October 11, 2012

Conditions

Disorder Related to Renal TransplantationHypercholesterolemia

Keywords

ImmunosuppressionEverolimusrosuvastatinfluvastatinLipid lowering

Outcome Measures

Primary Outcomes (2)

  • compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin

    Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin

    4 weeks

  • 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.

    Compare 24-h pharmacokinetics of renal transplant recipients with historic controls

    4 weeks

Secondary Outcomes (4)

  • 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.

    4 weeks

  • 2. Investigate P-gp activity in whole blood in everolimus treated patients

    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

    4 weeks

  • 4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)

    4 weeks

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

Rosuvastatin treatment for 4 weeks

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

20 mg rosuvastatin for 4 weeks

Also known as: Crestor
Rosuvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplant recipients with stable renal function (plasma creatinine \< 200 µmol/L)
  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0027, Norway

Location

Related Publications (1)

  • 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.

    PMID: 24521776DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Anders Åsberg, PhD

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2012

First Posted

February 2, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 12, 2012

Record last verified: 2012-10

Locations

NO(1)