Clinical trial NCT03543774: Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population
Official title: Lipid-lowering Regimes Improve Oxidative Stress, Tryptophan Degradation in Hypercholesterolemia Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypercholesterolemia
Chronic Kidney Diseases
Keywords: Chronic kidney disease
Lipid lowering therapy
Hypercholesterolemia
Lead sponsor: Hue University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Sassari
First posted: 2018-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: At the base time
measure: To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population and in healthy persons at the base time.
timeFrame: At the base time
measure: To measure the number of red blood cell, white blood cell and platelet in Vietnamese CKD population and in healthy persons at the base time.
timeFrame: At the base time
measure: To measure the serum level of MDA in Vietnamese CKD population and in healthy persons at the base time.
timeFrame: At the base time
measure: To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population and in healthy persons at the base time.
timeFrame: At the base time
measure: To measure the serum level of SGOT, SGPT, and Creatinin Kinase in Vietnamese CKD population and in healthy persons at the base time.
timeFrame: At the base time
Secondary outcomes:
measure: 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.
timeFrame: at 4th, 8th and 12th month
measure: To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population at 4th, 8th, 12th month.
timeFrame: at 4th, 8th and 12th month
measure: To measure the number of red blood cell, white blood cell and platelet in Vietnamese CKD population at 4th, 8th, 12th month.
timeFrame: at 4th, 8th and 12th month
measure: To measure the serum level of MDA in Vietnamese CKD population at 4th, 8th, 12th month.
timeFrame: at 4th, 8th and 12th month
measure: To measure the serum levels of SGOT, SGPT and Creatinine Kinase in Vietnamese CKD population at 4th month, 8th month and the 12th month
timeFrame: at 4th, 8th and 12th month
measure: To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population at 4th, 8th, 12th month.
timeFrame: at 4th, 8th and 12th month
Other outcomes:
Locations:
city: Hue
country: Vietnam
facility: Hue University of Medicine and Pharmacy
state: Thua Thien Hue
Study officials:
affiliation: Hue University of Medicine and Pharmacy
name: Duong Thi Ngoc Lan, Master
role: PRINCIPAL_INVESTIGATOR
References: