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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02103049

Enrollment

Registered

2014-04-03

Start date

2014-04-30

Completion date

2015-12-31

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Transplants

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.

Interventions

DRUGEzetimibe

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Change in oxidative markers	At enrolment, at three, six and nine months thereafter.	Change in oxidative markers, inflammation and endothelial function.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026