Clinical trial NCT02992548: Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Official title: Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
pravastatin
erythrocyte membrane fatty acid
Lead sponsor: Dong-A University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids. Erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.

Detailed description: Patients with chronic kidney disease (CKD) have higher risk of death and cardiovascular disease than general population. Treatment using statin has been decreased the risk of cardiovascular events in pre-dialysis CKD population. Supplementation with omega-3 fatty acid (FA) lowers the risk of cardiovascular death in patients with myocardial infarction. This cardioprotective effect of omega-3 FA can be explained by anti-inflammatory, anti-oxidative, or anti-thrombotic effects. Statin such as pravastatin is also known to have anti-inflammatory and antioxidant properties, suggesting that statin may replace the cardioprotective effect of omega-3 fatty acids.

Omega-3 FA such as EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid), and EPA/arachidonic acid ratio are well known as key indicators of cardiovascular disease. In addition, erythrocyte membrane oleic acid is significantly higher in patients with acute coronary syndrome than control subjects. The cardioprotective effect of omega-3 FA may also be related to decreased oleic acid content of erythrocyte membrane. There is no report about the effect of statin on FA including erythrocyte membrane oleic acid. As omega-3 FAs are recognized as therapeutic agents for reducing triglycerides, statin may affect on the erythrocyte membrane FA. Therefore, pravastatin supplementation can modify erythrocyte membrane FA contents including oleic acid in CKD patients.

Eligibility criteria: Inclusion Criteria:

* CKD patients who agreed with written informed consent
* CKD patients who do not take statin
* Who have LDL cholesterol over 100mg/dL and coronary vascular disease(CVD) or equivalent risk; Who have LDL cholesterol over 130mg/dL and two or more coronary vascular risk; Whose LDL cholesterol over 160mg/dL in patient with CKD stage 1 to 5 without dialysis.

Exclusion Criteria:

* Patients with acute illness, a history of active infection, CVD, acute kidney injury during the past 3 months, or a history of malignancy or liver disease
* Patients using statin, omega-3 fatty acid or sevelamer hydrochloride within 3 months
* Patients who experienced side effects by statin treatment
* Pregnant or pregnancy expected CKD patients
* Patient with dyslipidemia due to nephrotic syndrome
* Patient taken imaging study using contrast media during the past 14 days
* Patient with albumin level \< 3.0 g/dL

Primary outcomes:
measure: mean change of erythrocyte membrane fatty acid including oleic acid
timeFrame: 24 weeks after intervention
Secondary outcomes:
measure: mean change of total cholesterol
timeFrame: 24 weeks after intervention
measure: mean change of triglyceride
timeFrame: 24 weeks after intervention
measure: mean change of LDL-cholesterol
timeFrame: 24 weeks after intervention
measure: mean change of HDL-cholesterol
timeFrame: 24 weeks after intervention
measure: mean change of adiponectin
timeFrame: 24 weeks after intervention
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University
city: Busan
country: Korea, Republic of
facility: Inje University, Pusan Paik Hospital
Study officials:
affiliation: Dong-A University
name: Won Suk An, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Yeong Hoon Kim, MD
role: STUDY_DIRECTOR
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