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

Phase 4

Completed

• Conditions: Dyslipidemia; Transplants
• Interventions: Drug: Ezetimibe

• Registration Number: NCT02103049
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study First Submitted: 2014-03-31
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-03
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-16
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ezetimibe, dyslipidemia, kidney transplant	Ezetimibe	-

Primary Outcome Measures

Name	Time	Method
Decrease of LDL cholesterol concentration.	At enrolment, at three, six and nine months thereafter.	The investigators expect the LDL cholesterol concentration to lower for at least 10%.

Secondary Outcome Measures

Name	Time	Method
Change in oxidative markers	At enrolment, at three, six and nine months thereafter.	Change in oxidative markers, inflammation and endothelial function.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia