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The Impact of Ezetimibe on Biochemical Markers of Cardiovascular Risk in Kidney Transplant Patients

NCT02103049 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-05-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ezetimibe

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Gregor Mlinsek, MD, PhD · University Medical Center Ljubljana, Slovenia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103049 on ClinicalTrials.gov