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Trial record 27 of 75 for:    Recruiting, Not yet recruiting, Available Studies | "Hypercholesterolemia"

Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population (VietCKD)

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ClinicalTrials.gov Identifier: NCT03543774
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Università degli Studi di Sassari
Information provided by (Responsible Party):
Duong Thi Ngoc Lan, Hue University of Medicine and Pharmacy

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).

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

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.


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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




Primary Outcome Measures :
  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. [ 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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


Secondary Outcome Measures :
  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. [ 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


  2. 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

  3. 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


  4. 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

  5. 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

  6. 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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Duong Thi Ngoc Lan, Master 084-903572535 duongngoclan80@yahoo.com.vn
Contact: Ciriaco Carru, Professor 0039-3204299322 carru@uniss.it

Locations
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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         
Sponsors and Collaborators
Hue University of Medicine and Pharmacy
Università degli Studi di Sassari
Investigators
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Principal Investigator: Duong Thi Ngoc Lan, Master Hue University of Medicine and Pharmacy
  Study Documents (Full-Text)

Documents provided by Duong Thi Ngoc Lan, Hue University of Medicine and Pharmacy:
Study Protocol  [PDF] May 3, 2018
Statistical Analysis Plan  [PDF] May 5, 2018
Informed Consent Form  [PDF] May 3, 2018


Additional Information:
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Responsible Party: Duong Thi Ngoc Lan, Principal Investigator, Physician, Master degree, Hue University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03543774     History of Changes
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

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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
Keywords provided by Duong Thi Ngoc Lan, Hue University of Medicine and Pharmacy:
Chronic kidney disease
Lipid lowering therapy
Hypercholesterolemia
Additional relevant MeSH terms:
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Hypercholesterolemia
Kidney Diseases
Renal Insufficiency, Chronic
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