Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pitavastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, pitavastatin, erythrocyte membrane fatty acid
Eligibility 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
Sites / Locations
- Won Suk An
- Dong-A University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pitavastatin group
Atorvastatin group
Arm Description
Use of 2mg or 4mg Pitavastatin
Use of 10mg or 20mg Atorvastatin
Outcomes
Primary Outcome Measures
mean difference and change of erythrocyte membrane fatty acid including oleic acid
Secondary Outcome Measures
mean difference and change of total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol
mean difference and change of adiponectin
mean difference and change of glucose and glycosylated hemoglobin
mean difference and change of proteinuria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02863185
Brief Title
Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Official Title
Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dong-A University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, pitavastatin, erythrocyte membrane fatty acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pitavastatin group
Arm Type
Experimental
Arm Description
Use of 2mg or 4mg Pitavastatin
Arm Title
Atorvastatin group
Arm Type
Active Comparator
Arm Description
Use of 10mg or 20mg Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Pitavastatin
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
mean difference and change of erythrocyte membrane fatty acid including oleic acid
Time Frame
baseline and 24 weeks after intervention
Secondary Outcome Measure Information:
Title
mean difference and change of total cholesterol, triglyceride, LDL-cholesterol, HDL-cholesterol
Time Frame
baseline and 24 weeks after intervention
Title
mean difference and change of adiponectin
Time Frame
baseline and 24 weeks after intervention
Title
mean difference and change of glucose and glycosylated hemoglobin
Time Frame
baseline and 24 weeks after intervention
Title
mean difference and change of proteinuria
Time Frame
baseline and 24 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Won Suk An
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Dong-A University
City
Busan
ZIP/Postal Code
602715
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23687359
Citation
Tonelli M, Muntner P, Lloyd A, Manns B, Klarenbach S, Pannu N, James M, Hemmelgarn B; Alberta Kidney Disease Network. Association between LDL-C and risk of myocardial infarction in CKD. J Am Soc Nephrol. 2013 May;24(6):979-86. doi: 10.1681/ASN.2012080870. Epub 2013 May 16.
Results Reference
background
PubMed Identifier
21663949
Citation
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, Fellstrom B, Holdaas H, Tesar V, Wiecek A, Grobbee D, de Zeeuw D, Gronhagen-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.
Results Reference
background
PubMed Identifier
22883507
Citation
Ridker PM, Pradhan A, MacFadyen JG, Libby P, Glynn RJ. Cardiovascular benefits and diabetes risks of statin therapy in primary prevention: an analysis from the JUPITER trial. Lancet. 2012 Aug 11;380(9841):565-71. doi: 10.1016/S0140-6736(12)61190-8.
Results Reference
background
PubMed Identifier
12782616
Citation
Leaf A, Kang JX, Xiao YF, Billman GE. Clinical prevention of sudden cardiac death by n-3 polyunsaturated fatty acids and mechanism of prevention of arrhythmias by n-3 fish oils. Circulation. 2003 Jun 3;107(21):2646-52. doi: 10.1161/01.CIR.0000069566.78305.33. No abstract available.
Results Reference
background
PubMed Identifier
19539181
Citation
An WS, Kim SE, Kim KH, Lee S, Park Y, Kim HJ, Vaziri ND. Comparison of fatty acid contents of erythrocyte membrane in hemodialysis and peritoneal dialysis patients. J Ren Nutr. 2009 Jul;19(4):267-74. doi: 10.1053/j.jrn.2009.01.027.
Results Reference
result
PubMed Identifier
22901557
Citation
An WS, Lee SM, Son YK, Kim SE, Kim KH, Han JY, Bae HR, Rha SH, Park Y. Omega-3 fatty acid supplementation increases 1,25-dihydroxyvitamin D and fetuin-A levels in dialysis patients. Nutr Res. 2012 Jul;32(7):495-502. doi: 10.1016/j.nutres.2012.06.005. Epub 2012 Jul 20.
Results Reference
result
PubMed Identifier
23324995
Citation
Nozue T, Yamamoto S, Tohyama S, Fukui K, Umezawa S, Onishi Y, Kunishima T, Sato A, Nozato T, Miyake S, Takeyama Y, Morino Y, Yamauchi T, Muramatsu T, Hibi K, Michishita I. Effects of statins on serum n-3 to n-6 polyunsaturated fatty acid ratios in patients with coronary artery disease. J Cardiovasc Pharmacol Ther. 2013 Jul;18(4):320-6. doi: 10.1177/1074248412473202. Epub 2013 Jan 15.
Results Reference
result
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Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease
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