Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ezetimibe, dyslipidemia, kidney transplant | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxidative markers | Change in oxidative markers, inflammation and endothelial function. | At enrolment, at three, six and nine months thereafter. |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregor Mlinsek, MD, PhD | University Medical Center Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana | Ljubljana | Slovenia | 1000 | Slovenia |
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided