Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

Last updated: August 12, 2019
Sponsor: Hue University of Medicine and Pharmacy
Overall Status: Active - Recruiting

Phase

4

Condition

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT03543774
HueUMP
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study aims to determine the mechanisms underlying dyslipidemia in chronic kidney disease (CKD) and effect of lipid-lowering therapies in patients with CKD via parameters of lipid, oxidative stress, tryptophan delegation as well as renal function and side effects. Thirty 3,4 CKD patients with low-density lipoprotein (LDL) > 100 mg/mL (2,59mmol/l), randomly receive three different LDL lipid-lowering therapies: Simvastatin (40 mg/day) or ezetimibe/simvastatin combination (10/20 mg/day or 10/40 mg/day).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages Eligible for Study:

  • ≥ 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 orkidney transplantation, statin treatment in people with one or more of thefollowing: known coronary disease (myocardial infarction or coronaryrevascularization); diabetes mellitus; prior ischemic stroke; estimated 10-yearincidence 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 withurinary protein excretion rate >300mg/24 h)

  • LDL cholesterol concentration > 100 mg/dl (2,59 mmol/l)

Exclusion

Exclusion Criteria: In adults with dialysis-dependent CKD

  • 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

Study Design

Total Participants: 30
Study Start date:
June 15, 2018
Estimated Completion Date:
October 15, 2020

Study Description

The prevalence of chronic kidney disease (CKD) in Vietnamese population is increasing along with hypertension and diabetes. In CKD patient, cardiovascular disease (CVD) is the leading cause of mortality. The lipidemic disorder is one of the CV risk factors in CKD but it was not fully concerned in Viet Nam.

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.

Connect with a study center

  • Hue University of Medicine and Pharmacy

    Hue, Thua Thien Hue 0234
    Vietnam

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.