Back to resultsThe Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients
Primary Purpose
Dyslipidemia, Transplants
Status
Completed
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
Ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemia
Eligibility Criteria
Inclusion Criteria:
LDL > 2.5 mM, Already treated with statin, Stable renal function of various GFR, Men or women older than 18 years, Signed informed consent.
Exclusion Criteria:
Acute heart disease or any heart disease in the last 3 months, kidney graft failure, active systemic inflammatory disease, active malignant disease, chronic diarrhea and malabsorption, transaminases increased > 3 fold, creatin kinase increased > 5 fold, hypersensitivity reactions, active peptic ulcer disease.
Sites / Locations
- University Medical Center Ljubljana
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ezetimibe, dyslipidemia, kidney transplant
Arm Description
Outcomes
Primary Outcome Measures
Decrease of LDL cholesterol concentration.
The investigators expect the LDL cholesterol concentration to lower for at least 10%.
Secondary Outcome Measures
Change in oxidative markers
Change in oxidative markers, inflammation and endothelial function.
Full Information
NCT ID
NCT02103049
First Posted
March 31, 2014
Last Updated
May 16, 2016
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT02103049
Brief Title
The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients
Official Title
The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In kidney transplant patients atherosclerosis process is accelerated even in asymptomatic patients. This is mainly the consequence of immunosuppressive therapy. Dyslipidemia is treated with statins in low doses only as high doses can lead to rhabdomyolysis and are therefore contraindicated. As second lipid lowering agent most commonly ezetimibe is used. The investigators hypothesise that ezetimibe as a second lipid lowering drug in kidney transplant patients lowers LDL cholesterol for additional 10 per cent.
Detailed Description
In addition to observing the lipid profile the investigators intend to look for other pathophysiological effects of ezetimibe, such as its influence on oxidative stress, endothelial function and inflammatory biochemical markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Transplants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ezetimibe, dyslipidemia, kidney transplant
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Intervention Description
Patients on standard immunosuppressive therapy with statin will be added ezetimibe for 6 months. Thereafter ezetimibe will be discontinued for three months. Biochemical parameters will be analysed at the time of enrolment, after 3 months, 6 months and 9 months.
Primary Outcome Measure Information:
Title
Decrease of LDL cholesterol concentration.
Description
The investigators expect the LDL cholesterol concentration to lower for at least 10%.
Time Frame
At enrolment, at three, six and nine months thereafter.
Secondary Outcome Measure Information:
Title
Change in oxidative markers
Description
Change in oxidative markers, inflammation and endothelial function.
Time Frame
At enrolment, at three, six and nine months thereafter.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
LDL > 2.5 mM, Already treated with statin, Stable renal function of various GFR, Men or women older than 18 years, Signed informed consent.
Exclusion Criteria:
Acute heart disease or any heart disease in the last 3 months, kidney graft failure, active systemic inflammatory disease, active malignant disease, chronic diarrhea and malabsorption, transaminases increased > 3 fold, creatin kinase increased > 5 fold, hypersensitivity reactions, active peptic ulcer disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor Mlinsek, MD, PhD
Organizational Affiliation
University Medical Center Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Learn more about this trial
The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients
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