Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population (VietCKD)

Hue University of Medicine and Pharmacy

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Diseases; Hypercholesterolemia

Treatments: Drug: Simvastatin 40mg; Drug: Ezetimibe/simvastatin 10/40 mg/day; Drug: Ezetimibe/simvastatin 10/20 mg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT03543774

HueUMP

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

simvastatin treatment

Active Comparator group

Treatment:

Drug: Simvastatin 40mg

EZE/simvastatin 10/20 mg treatment

Sham Comparator group

Treatment:

Drug: Ezetimibe/simvastatin 10/20 mg/day

EZE/simvastatin 10/40 mg treatment

Sham Comparator group

Treatment:

Drug: Ezetimibe/simvastatin 10/40 mg/day