Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population (VietCKD)
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| ClinicalTrials.gov Identifier: NCT03543774 |
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Recruitment Status : Unknown
Verified August 2019 by Duong Thi Ngoc Lan, Hue University of Medicine and Pharmacy.
Recruitment status was: Recruiting
First Posted : June 1, 2018
Last Update Posted : August 13, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercholesterolemia Chronic Kidney Diseases | Drug: Simvastatin 40mg Drug: Ezetimibe/simvastatin 10/20 mg/day Drug: Ezetimibe/simvastatin 10/40 mg/day | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Lipid-lowering Regimes Improve Oxidative Stress, Tryptophan Degradation in Hypercholesterolemia Chronic Kidney Disease Patients |
| Actual Study Start Date : | June 15, 2018 |
| Estimated Primary Completion Date : | March 15, 2020 |
| Estimated Study Completion Date : | October 15, 2020 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: simvastatin treatment |
Drug: Simvastatin 40mg
Simvastatin mono-therapy at the dose of 40 mg/day for 12 months |
| Sham Comparator: EZE/simvastatin 10/20 mg treatment |
Drug: Ezetimibe/simvastatin 10/20 mg/day
Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months |
| Sham Comparator: EZE/simvastatin 10/40 mg treatment |
Drug: Ezetimibe/simvastatin 10/40 mg/day
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. [ Time Frame: 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.
- To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population and in healthy persons at the base time. [ Time Frame: At the base time ]The serum level of Taurine, Tryp, and Kyn will be measured in micromol/L
- 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. [ Time Frame: At the base time ]The number of red blood cell, white blood cell, and platelet will be measured in number/L
- To measure the serum level of MDA in Vietnamese CKD population and in healthy persons at the base time. [ Time Frame: At the base time ]The serum level of MDA will be measured in nmol/L
- To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population and in healthy persons at the base time. [ Time Frame: At the base time ]The serum level of Albuminuria and urine Creatinine will be measured in mg/dL
- To measure the serum level of SGOT, SGPT, and Creatinin Kinase in Vietnamese CKD population and in healthy persons at the base time. [ Time Frame: At the base time ]The serum level of SGOT, SGPT and Creatinin Kinase will be measured in Units/L
- 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. [ Time Frame: at 4th, 8th and 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
- To measure the serum level of Taurine, Tryp, and Kyn in Vietnamese CKD population at 4th, 8th, 12th month. [ Time Frame: at 4th, 8th and 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
- To measure the number of red blood cell, white blood cell and platelet in Vietnamese CKD population at 4th, 8th, 12th month. [ Time Frame: at 4th, 8th and 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
- To measure the serum level of MDA in Vietnamese CKD population at 4th, 8th, 12th month. [ Time Frame: at 4th, 8th and 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
- To measure the serum levels of SGOT, SGPT and Creatinine Kinase in Vietnamese CKD population at 4th month, 8th month and the 12th month [ Time Frame: at 4th, 8th and 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
- To measure the level of Albuminuria and urine Creatinine in Vietnamese CKD population at 4th, 8th, 12th month. [ Time Frame: at 4th, 8th and 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543774
| Contact: Duong Thi Ngoc Lan, Master | 084-903572535 | duongngoclan80@yahoo.com.vn | |
| Contact: Ciriaco Carru, Professor | 0039-3204299322 | carru@uniss.it |
| Vietnam | |
| Hue University of Medicine and Pharmacy | Recruiting |
| Hue, Thua Thien Hue, Vietnam, 0234 | |
| Contact: Nguyen Thanh Thao 84.234.3822873 hcmp@huemed-univ.edu.vn | |
| Contact: Nguyen Thanh Thao 84.234.3822873 thaonrad@gmail.com | |
| Principal Investigator: Duong Thi Ngoc Lan, Master | |
| Sub-Investigator: Le Van An, A/Professor | |
| Principal Investigator: | Duong Thi Ngoc Lan, Master | Hue University of Medicine and Pharmacy |
Documents provided by Duong Thi Ngoc Lan, Hue University of Medicine and Pharmacy:
| Responsible Party: | Duong Thi Ngoc Lan, Principal Investigator, Physician, Master degree, Hue University of Medicine and Pharmacy |
| ClinicalTrials.gov Identifier: | NCT03543774 |
| Other Study ID Numbers: |
HueUMP |
| First Posted: | June 1, 2018 Key Record Dates |
| Last Update Posted: | August 13, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Chronic kidney disease Lipid lowering therapy Hypercholesterolemia |
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Kidney Diseases Renal Insufficiency, Chronic Hypercholesterolemia Urologic Diseases Renal Insufficiency Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin |
Ezetimibe Ezetimibe, Simvastatin Drug Combination Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |