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Trial record 30 of 7870 for:    "Kidney Diseases"

Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT02863185
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
WON SUK AN, Dong-A University

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Pitavastatin Drug: Atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Pitavastatin group
Use of 2mg or 4mg Pitavastatin
Drug: Pitavastatin
Active Comparator: Atorvastatin group
Use of 10mg or 20mg Atorvastatin
Drug: Atorvastatin



Primary Outcome Measures :
  1. mean difference and change of erythrocyte membrane fatty acid including oleic acid [ Time Frame: baseline and 24 weeks after intervention ]

Secondary Outcome Measures :
  1. mean difference and change of total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol [ Time Frame: baseline and 24 weeks after intervention ]
  2. mean difference and change of adiponectin [ Time Frame: baseline and 24 weeks after intervention ]
  3. mean difference and change of glucose and glycosylated hemoglobin [ Time Frame: baseline and 24 weeks after intervention ]
  4. mean difference and change of proteinuria [ Time Frame: baseline and 24 weeks after intervention ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863185


Contacts
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Contact: Su Mi Lee, MD +82512405549 promise131@hanmail.net

Locations
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Korea, Republic of
Won Suk An Recruiting
Busan, Korea, Republic of, 602-715
Contact: Won Suk An, M.D., Ph.D.    +82-51-240-2811    anws@dau.ac.kr   
Dong-A University Not yet recruiting
Busan, Korea, Republic of, 602715
Contact: Su Mi Lee, MD    +822405549    promise131@hanmail.net   
Sponsors and Collaborators
Dong-A University

Publications of Results:
Other Publications:
Baigent C, Landray MJ, Reith C, Emberson J, Wheeler DC, Tomson C, Wanner C, Krane V, Cass A, Craig J, Neal B, Jiang L, Hooi LS, Levin A, Agodoa L, Gaziano M, Kasiske B, Walker R, Massy ZA, Feldt-Rasmussen B, Krairittichai U, Ophascharoensuk V, Fellström B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Grönhagen-Riska C, Dasgupta T, Lewis D, Herrington W, Mafham M, Majoni W, Wallendszus K, Grimm R, Pedersen T, Tobert J, Armitage J, Baxter A, Bray C, Chen Y, Chen Z, Hill M, Knott C, Parish S, Simpson D, Sleight P, Young A, Collins R; SHARP Investigators. The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet. 2011 Jun 25;377(9784):2181-92. doi: 10.1016/S0140-6736(11)60739-3. Epub 2011 Jun 12.

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Responsible Party: WON SUK AN, Professor, Dong-A University
ClinicalTrials.gov Identifier: NCT02863185     History of Changes
Other Study ID Numbers: Pita_2016
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by WON SUK AN, Dong-A University:
chronic kidney disease
pitavastatin
erythrocyte membrane fatty acid

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Atorvastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors