Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population
NCT ID: NCT03543774
Last Updated: 2019-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2018-06-15
2020-10-15
Brief Summary
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Detailed Description
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Hypocholesterolemia therapy has shown many benefits; however, its effects on OS and endothelial function are still not fully evidenced.
In clinical practice, physicians always concern the effects and safety before giving the prescription. However, despite the high frequency of statin treatment, only 1/3 of CKD patients achieved the LDL-C goal. Whether high-dose of statins mono-therapy is more effective in LDL-C lowering is still unclear, but are associated with a high rate of hepatotoxicity, myopathy.
Lowering LDL-C with statin mono-therapy and statin/ezetimibe combination reduces the risk of CVD in population without kidney disease. Which Cholesterol-lowering therapies are suitable for stage 3,4 CKD patients in term of e-GFR reduction and side effects? There is no data related to this field in the Vietnamese CKD population.
Thus, more advanced lipid-lowering therapies and a better understanding of the mechanism is needed for treatment strategy of hyperlipidemia in Vietnamese patients with CKD.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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simvastatin treatment
Simvastatin 40mg
Simvastatin mono-therapy at the dose of 40 mg/day for 12 months
EZE/simvastatin 10/20 mg treatment
Ezetimibe/simvastatin 10/20 mg/day
Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months
EZE/simvastatin 10/40 mg treatment
Ezetimibe/simvastatin 10/40 mg/day
Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months
Interventions
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Simvastatin 40mg
Simvastatin mono-therapy at the dose of 40 mg/day for 12 months
Ezetimibe/simvastatin 10/20 mg/day
Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months
Ezetimibe/simvastatin 10/40 mg/day
Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months
Eligibility Criteria
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Inclusion Criteria
* ≥ 50 years old but not treated with chronic dialysis or kidney transplantation
* In adults aged 18-49 years with CKD but not treated with chronic dialysis or kidney transplantation, statin treatment in people with one or more of the following: known coronary disease (myocardial infarction or coronary revascularization); diabetes mellitus; prior ischemic stroke; estimated 10-year incidence of coronary death or non-fatal myocardial infarction \> 10%.
* CKD in the 3,4 stage: (e-GFR: 15-60 ml/min/1.73 m2)
* CKD proteinuria (defined as Creatinine clearance \>20 ml/min/1.73 m2 combines with urinary protein excretion rate \>300mg/24 h)
* LDL cholesterol concentration \> 100 mg/dl (2,59 mmol/l)
Exclusion Criteria
* Heart failure (New York Heart Association class III or more)
* Previous or concomitant treatment with corticoids, statin, immunosuppressive agents, vitamin B6, B12, folate.
* Pregnancy
* Patients who do not agree to participate the research
* Patients are unable to understand the purposes and the risks of the study
18 Years
ALL
Yes
Sponsors
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Università degli Studi di Sassari
OTHER
Hue University of Medicine and Pharmacy
OTHER
Responsible Party
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Duong Thi Ngoc Lan
Principal Investigator, Physician, Master degree
Principal Investigators
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Duong Thi Ngoc Lan, Master
Role: PRINCIPAL_INVESTIGATOR
Hue University of Medicine and Pharmacy
Locations
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Hue University of Medicine and Pharmacy
Huế, Thừa Thiên Huế Province, Vietnam
Countries
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Central Contacts
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Facility Contacts
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References
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Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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A Trial of Pitavastatin Versus Rosuvastatin for Dyslipidemia in Chronic Kidney Disease
Effects of lowering LDL cholesterol on progression of kidney disease
Ezetimibe and simvastatin for the prevention of cardiovascular events in predialysis chronic kidney disease patients: a review
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.
Other Identifiers
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HueUMP
Identifier Type: -
Identifier Source: org_study_id
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