NCT03543774

Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

Lipid-lowering Regimes Improve Oxidative Stress, Tryptophan Degradation in Hypercholesterolemia Chronic Kidney Disease Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hue University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Hypercholesterolemia
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	Simvastatin 40mg	Simvastatin mono-therapy at the dose of 40 mg/day for 12 months
DRUG	Ezetimibe/simvastatin 10/20 mg/day	Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months
DRUG	Ezetimibe/simvastatin 10/40 mg/day	Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months

Timeline

• Start date: 2018-06-15
• Primary completion: 2020-03-15
• Completion: 2020-10-15
• First posted: 2018-06-01
• Last updated: 2019-08-13

Locations

1 site across 1 country: Vietnam

Regulatory

• FDA-regulated drug study