Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

NCT03543774 | Unknown Phase 4 FDA Drug

• 1 other identifier: HueUMP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypercholesterolemia; Chronic Kidney Diseases

Keywords

Chronic kidney disease; Lipid lowering therapy; Hypercholesterolemia

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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

  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

  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

  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

  At the base time

Secondary Outcomes (6)

• 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.

  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.

  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.

  at 4th, 8th and 12th month

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

  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

  at 4th, 8th and 12th month

Study Arms (3)

simvastatin treatment

ACTIVE COMPARATOR

Drug: Simvastatin 40mg

EZE/simvastatin 10/20 mg treatment

SHAM COMPARATOR

Drug: Ezetimibe/simvastatin 10/20 mg/day

EZE/simvastatin 10/40 mg treatment

SHAM COMPARATOR

Drug: Ezetimibe/simvastatin 10/40 mg/day

Interventions

Simvastatin 40mg DRUG

Simvastatin mono-therapy at the dose of 40 mg/day for 12 months

simvastatin treatment

Ezetimibe/simvastatin 10/20 mg/day DRUG

Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months

EZE/simvastatin 10/20 mg treatment

Ezetimibe/simvastatin 10/40 mg/day DRUG

Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months

EZE/simvastatin 10/40 mg treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead
• Università degli Studi di Sassari: collaborator

Study Sites (1)

Hue University of Medicine and Pharmacy

Huế, Thừa Thiên Huế Province, 0234, Vietnam

RECRUITING

Related Publications (1)

• Tunnicliffe DJ, Palmer SC, Cashmore BA, Saglimbene VM, Krishnasamy R, Lambert K, Johnson DW, Craig JC, Strippoli GF. HMG CoA reductase inhibitors (statins) for people with chronic kidney disease not requiring dialysis. Cochrane Database Syst Rev. 2023 Nov 29;11(11):CD007784. doi: 10.1002/14651858.CD007784.pub3.

  PMID: 38018702 DERIVED

Related Links

• A Trial of Pitavastatin Versus Rosuvastatin for Dyslipidemia in Chronic Kidney Disease
• Effects of lowering LDL cholesterol on progression of kidney disease
• Ezetimibe and simvastatin for the prevention of cardiovascular events in predialysis chronic kidney disease patients: a review
• The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial.

MeSH Terms

Conditions

Hypercholesterolemia; Renal Insufficiency, Chronic

Interventions

Simvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Duong Thi Ngoc Lan, Master

  Hue University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duong Thi Ngoc Lan, Master

CONTACT

084-903572535; duongngoclan80@yahoo.com.vn

Ciriaco Carru, Professor

CONTACT

0039-3204299322; carru@uniss.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physician, Master degree

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: June 1, 2018
• Study Start: June 15, 2018
• Primary Completion: March 15, 2020
• Study Completion: October 15, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

VN (1)