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The Rosuvastatin In TrAnsplant Recipients Study (RITA)

Primary Purpose

Disorder Related to Renal Transplantation, Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
University of Oslo School of Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder Related to Renal Transplantation focused on measuring Immunosuppression, Everolimus, rosuvastatin, fluvastatin, Lipid lowering

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital, Rikshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rosuvastatin

Arm Description

Rosuvastatin treatment for 4 weeks

Outcomes

Primary Outcome Measures

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
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

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.
2. Investigate P-gp activity in whole blood in everolimus treated patients
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. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)

Full Information

First Posted
January 24, 2012
Last Updated
October 11, 2012
Sponsor
University of Oslo School of Pharmacy
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01524601
Brief Title
The Rosuvastatin In TrAnsplant Recipients Study
Acronym
RITA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oslo School of Pharmacy
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder Related to Renal Transplantation, Hypercholesterolemia
Keywords
Immunosuppression, Everolimus, rosuvastatin, fluvastatin, Lipid lowering

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Description
Rosuvastatin treatment for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
20 mg rosuvastatin for 4 weeks
Primary Outcome Measure Information:
Title
compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin
Description
Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin
Time Frame
4 weeks
Title
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.
Description
Compare 24-h pharmacokinetics of renal transplant recipients with historic controls
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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
Title
2. Investigate P-gp activity in whole blood in everolimus treated patients
Time Frame
4 weeks
Title
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
Title
4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Åsberg, PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24521776
Citation
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.
Results Reference
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The Rosuvastatin In TrAnsplant Recipients Study

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