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

U

University Medical Centre Ljubljana

Status and phase

Completed
Phase 4

Conditions

Transplants
Dyslipidemia

Treatments

Drug: Ezetimibe

Study type

Interventional

Funder types

Other

Identifiers

NCT02103049
UMCL-2014-TX

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Ezetimibe, dyslipidemia, kidney transplant
Other group
Treatment:
Drug: Ezetimibe

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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