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. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

NCT03543774.

Trial name or title Lipid‐lowering therapies in Vietnamese Chronic Kidney Disease population (VietCKD)
Methods Randomised, parallel assignment, open‐label study
Participants Estimated Enrollment: 30
Inclusion Criteria:

  1. ages eligible for study: ≥ 50 years old but not treated with chronic dialysis or kidney transplantationIn 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 (MI or coronary revascularisation); diabetes mellitus; prior ischaemic stroke; estimated 10‐year incidence of coronary death or non‐fatal MI > 10%;

  2. CKD in the 3,4 stage: (e‐GFR: 15‐60 mL/minute/1.73 m2);

  3. CKD proteinuria (defined as creatinine clearance > 20 mL/min/1.73 m2 combines with urinary protein excretion rate > 300 mg/24 hours);

  4. LDL cholesterol concentration > 100 mg/dL (2.59 mmol/L).


Exclusion Criteria:
(in adults with dialysis‐dependent CKD)

  1. heart failure (New York Heart Association class III or more);

  2. previous or concomitant treatment with corticoids, statin, immunosuppressive agents, vitamin B6, B12, folate;

  3. pregnancy;

  4. patients who do not agree to participate the research;

  5. patients are unable to understand the purposes and the risks of the study.
Interventions Arm1: simvastatin 40 mg/day
Arm2: ezetimibe/simvastatin 10 mg/20 mg/day
Arm3: ezetimibe/simvastatin 10 mg/40 mg/day
Outcomes Primary:

  1. to measure the serum level of TC, LDL‐C, HDL‐C, TG, creatinine, uric acid, and allantoin in Vietnamese CKD population and in healthy persons at the base time;

  2. to measure the serum level of taurine, Tryp, and Kyn in Vietnamese CKD population and in healthy persons at the base time;

  3. to measure the number of red blood cells, white blood cells and platelets in Vietnamese CKD population and in healthy persons at the base time;

  4. to measure the serum level of malondialdehyde (MDA) in Vietnamese CKD population and in healthy persons at the base time;

  5. to measure the level of albuminuria and urine creatinine in Vietnamese CKD population and in healthy persons at the base time;

  6. to measure the serum level of ALT, AST, and CK in Vietnamese CKD population and in healthy persons at the base time.


Secondary:

  1. to measure the serum level of TC, LDL‐C, HDL‐C, TG, creatinine, uric acid, and allantoin in Vietnamese CKD population at 4th, 8th, 12th month;

  2. to measure the serum level of taurine, Tryp, and Kyn in Vietnamese CKD population at 4th, 8th, 12th month;

  3. to measure the number of red blood cells, white blood cells and platelets in Vietnamese CKD population at 4th, 8th, 12th month;

  4. to measure the serum level of MDA in Vietnamese CKD population at 4th, 8th, 12th month.

  5. to measure the serum levels of ALT, AST and Creatinine Kinase in Vietnamese CKD population at 4th month, 8th month and the 12th month;

  6. to measure the level of albuminuria and urine creatinine in Vietnamese CKD population at 4th, 8th, 12th month.
Starting date June 15, 2018
Contact information Duong Thi Ngoc Lan, Master; 084‐903572535; duongngoclan80@yahoo.com.vn
Ciriaco Carru, Professor; 0039‐3204299322; carru@uniss.it
Notes Location: Vietnam
Expected completion date: September 15, 2019

ALT: alanine aminotransferase; AST: aspartate aminotransferase; CK: creatine kinase; CKD: chronic kidney disease; e‐GFR: estimated glomerular filtration rate; HbA1c: glycated haemoglobin; HDL‐C: high‐density lipoprotein cholesterol; IVUS: intravascular ultrasound; LDL‐C: low‐density lipoprotein cholesterol; MI: myocardial infarction; TC: total cholesterol; TG: triglycerides; RCT: randomised controlled trial; ULN: upper limit of normal; Tryp, and Kyn: tryptophan and kynurenine.