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

NCT02103049 | Completed Phase 4

• 1 other identifier: UMCL-2014-TX
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia; Transplants

Outcome Measures

Primary Outcomes (1)

• Decrease of LDL cholesterol concentration.

  The investigators expect the LDL cholesterol concentration to lower for at least 10%.

  At enrolment, at three, six and nine months thereafter.

Secondary Outcomes (1)

• Change in oxidative markers

  At enrolment, at three, six and nine months thereafter.

Study Arms (1)

Ezetimibe, dyslipidemia, kidney transplant

OTHER

Drug: Ezetimibe

Interventions

Ezetimibe DRUG

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.

Ezetimibe, dyslipidemia, kidney transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL \> 2.5 mM, Already treated with statin, Stable renal function of various GFR, Men or women older than 18 years, Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, Slovenia, 1000, Slovenia

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gregor Mlinsek, MD, PhD

  University Medical Center Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

SL (1)