Overview

This trial is active, not recruiting.

Condition chronic kidney disease
Treatments pitavastatin, atorvastatin
Phase phase 4
Sponsor Dong-A University
Start date May 2016
End date December 2018
Trial size 72 participants
Trial identifier NCT02863185, Pita_2016

Summary

Patients with chronic kidney disease (CKD) are high risk for death and cardiac disease is the major cause of death. CKD patients commonly have traditional risk factors for coronary artery disease, such as age, gender, hypertension, cigarette smoking, and dyslipidemia. Previous studies have reported that reducing cholesterol levels is associated with reducing morbidity and mortality from atherosclerosis. In particular, pharmacologic treatment using statin has been decreased the risk of adverse cardiovascular events in CKD population. Therefore, guidelines recommended the use of statin in CKD patients. On the other hands, niacin or fibrates is not recommended concomitantly with statins in patients with CKD because of increased risk of adverse events. In addition, recent study has reported that there was no incremental clinical benefit from the addition of niacin to statin therapy, in further decreasing the incidence of major cardiac events.

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-thrombic effects. In addition, omega-3 FA modulates cell membrane receptors and affects signal transduction and eicosanoid metabolism. The erythrocyte membrane content of FA has been shown to correlated with the FA content of the myocardium. The risk of cardiovascular disease is significantly reduced in patients with high omega-3 FA, such as eicosapentanoic acid or docosahexaenoic acid (DHA), in the erythrocyte membrane. In contrast, high levels of erythrocyte membrane total trans-FA, trans-oleic acid, and arachidonic acid (AA) are associated with an increased risk of cardiovascular disease. Erythrocyte membrane monounsaturated FA (MUFA) content, including oleic acid, is significantly higher in patients with acute coronary syndrome than control subjects. The erythrocyte membrane oleic acid content was also higher in dialysis patients who have high risks of cardiovascular disease compared to control subjects. Therefore, the modification of erythrocyte membrane FA content is very important with respect to cardiovascular disease. In a previous study, erythrocyte membrane omega-3 FA was shown to be increased and the MUFA content was decreased after omega-3 FA supplementation in HD patients. However, there are no reports about the effect of statin on the erythrocyte membrane FA composition in CKD. Recent study has reported that those with pitavastatin 4mg were decreased DHA to AA ratio, but those with pravastatin 20 mg were not change the DHA to AA ratio in patient with CAD. Statin may have important role on the modulation of erythrocyte membrane FA. In this study, the investigators hypothesized that pitavastatin supplementation can modify erythrocyte membrane FA content, including MUFA and oleic acid, in CKD patients. In addition, the investigators evaluated the effect of pitavastatin on adiponectin and glucose level in CKD patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Use of 2mg or 4mg Pitavastatin
pitavastatin
(Active Comparator)
Use of 10mg or 20mg Atorvastatin
atorvastatin

Primary Outcomes

Measure
mean difference and change of erythrocyte membrane fatty acid including oleic acid
time frame: baseline and 24 weeks after intervention

Secondary Outcomes

Measure
mean difference and change of total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol
time frame: baseline and 24 weeks after intervention
mean difference and change of adiponectin
time frame: baseline and 24 weeks after intervention
mean difference and change of glucose and glycosylated hemoglobin
time frame: baseline and 24 weeks after intervention
mean difference and change of proteinuria
time frame: baseline and 24 weeks after intervention

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: - CKD patients who agreed with written informed consent - CKD patients who do not taking statin agent. - 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

Additional Information

Official title Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Dong-A University.