A Phase 4 interventional study of Simvastatin 40mg and Ezetimibe/simvastatin 10/20 mg/day in Hypercholesterolemia and Chronic Kidney Diseases, sponsored by Hue University of Medicine and Pharmacy. Status unknown at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Hue University of Medicine and Pharmacy · Phase 4, Interventional, and Treatment
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).
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Hue University of Medicine and Pharmacy is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Ages Eligible for Study:
Exclusion Criteria:
In adults with dialysis-dependent CKD
Drug: Simvastatin 40mg
Drug: Ezetimibe/simvastatin 10/20 mg/day
Drug: Ezetimibe/simvastatin 10/40 mg/day
Simvastatin mono-therapy at the dose of 40 mg/day for 12 months
Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months
Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months
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.
The serum level of TC, LDL-C, HDL-C, TG, Creatinine, uric acid, and allantoin will be measured in mg/dL.
Time frame: At the base time
To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population and in healthy persons at the base time.
The serum level of Taurine, Tryp, and Kyn will be measured in micromol/L
Time frame: At the base time
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.
The number of red blood cell, white blood cell, and platelet will be measured in number/L
Time frame: At the base time
To measure the serum level of MDA in Vietnamese CKD population and in healthy persons at the base time.
The serum level of MDA will be measured in nmol/L
Time frame: At the base time
To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population and in healthy persons at the base time.
The serum level of Albuminuria and urine Creatinine will be measured in mg/dL
Time frame: At the base time
To measure the serum level of SGOT, SGPT, and Creatinin Kinase in Vietnamese CKD population and in healthy persons at the base time.
The serum level of SGOT, SGPT and Creatinin Kinase will be measured in Units/L
Time frame: At the base time
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.
The serum level of TC, LDL-C, HDL-C, TG, Creatinine, uric acid, and allantoin will be measured in mg/dL. The change of results during treatment will be described and will be compared in 3 different groups
Time frame: at 4th, 8th and 12th month
To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population at 4th, 8th, 12th month.
The level of Taurine, Tryp, and Kyn will be measured in micromol/L. The change of results during treatment will be described and will be compared in 3 different groups
Time frame: at 4th, 8th and 12th month
To measure the number of red blood cell, white blood cell and platelet in Vietnamese CKD population at 4th, 8th, 12th month.
The number of red blood cell, white blood cell, and platelet will be measured in number/L. The change of results during treatment will be described and will be compared in 3 different groups
Time frame: at 4th, 8th and 12th month
To measure the serum level of MDA in Vietnamese CKD population at 4th, 8th, 12th month.
The serum level of MDA will be serum in nmol/L. The change of results during treatment will be described and will be compared in 3 different groups
Time frame: at 4th, 8th and 12th month
To measure the serum levels of SGOT, SGPT and Creatinine Kinase in Vietnamese CKD population at 4th month, 8th month and the 12th month
The unexpected effects of each treatment therapy on the liver and on the muscle will be accessed by measuring the level of SGOT, SGPT and Creatinine Kinase. These laboratory test will be measured at 4th month, 8th month and the 12th month. These results will be compared in 3 different groups
Time frame: at 4th, 8th and 12th month
To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population at 4th, 8th, 12th month.
The level of Albuminuria and urine Creatinine will be measured in mg/dL. The change of results during treatment will be described and will be compared in 3 different groups
Time frame: at 4th, 8th and 12th month
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Hue University of Medicine and Pharmacy