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Effect of Pravastatin 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
Pravastatin
Sponsored by
Dong-A University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, pravastatin, erythrocyte membrane fatty acid

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dong-A University
  • Inje University, Pusan Paik Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pravastatin group

Arm Description

Use of pravastatin 20mg to 40mg

Outcomes

Primary Outcome Measures

mean change of erythrocyte membrane fatty acid including oleic acid

Secondary Outcome Measures

mean change of total cholesterol
mean change of triglyceride
mean change of LDL-cholesterol
mean change of HDL-cholesterol
mean change of adiponectin

Full Information

First Posted
December 10, 2016
Last Updated
March 8, 2019
Sponsor
Dong-A University
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1. Study Identification

Unique Protocol Identification Number
NCT02992548
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (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
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.

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, pravastatin, erythrocyte membrane fatty acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pravastatin group
Arm Type
Experimental
Arm Description
Use of pravastatin 20mg to 40mg
Intervention Type
Drug
Intervention Name(s)
Pravastatin
Primary Outcome Measure Information:
Title
mean change of erythrocyte membrane fatty acid including oleic acid
Time Frame
24 weeks after intervention
Secondary Outcome Measure Information:
Title
mean change of total cholesterol
Time Frame
24 weeks after intervention
Title
mean change of triglyceride
Time Frame
24 weeks after intervention
Title
mean change of LDL-cholesterol
Time Frame
24 weeks after intervention
Title
mean change of HDL-cholesterol
Time Frame
24 weeks after intervention
Title
mean change of adiponectin
Time Frame
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Suk An, MD
Organizational Affiliation
Dong-A University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yeong Hoon Kim, MD
Organizational Affiliation
Inje University
Official's Role
Study Director
Facility Information:
Facility Name
Dong-A University
City
Busan
ZIP/Postal Code
602715
Country
Korea, Republic of
Facility Name
Inje University, Pusan Paik Hospital
City
Busan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

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