Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

• Status: Unknown status
• Trial end date: 2020-10-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hue University of Medicine and Pharmacy
• Collaborator: Università degli Studi di Sassari
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

Criteria

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