HypercholesterolemiaPhase 4VietCKDNCT03543774
Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population
A Phase 4 study testing Simvastatin 40mg, Ezetimibe/simvastatin 10/20 mg/day and Ezetimibe/simvastatin 10/40 mg/day in people with Hypercholesterolemia and Chronic Kidney Diseases, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Chronic Kidney Diseases
- What is being tested?
- Simvastatin 40mg, Ezetimibe/simvastatin 10/20 mg/day and Ezetimibe/simvastatin 10/40 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Jun 2018to 15 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Hue University of Medicine and Pharmacy
Huế, Thừa Thiên Huế Province, 0234
Nguyen Thanh Thao, 84.234.3822873, hcmp@huemed-univ.edu.vn
Nguyen Thanh Thao, 84.234.3822873, thaonrad@gmail.com
About this study
Official title: Lipid-lowering Regimes Improve Oxidative Stress, Tryptophan Degradation in Hypercholesterolemia Chronic Kidney Disease Patients
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).
Read the 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.
- Conditions
- Hypercholesterolemia, Chronic Kidney Diseases
- Being tested
- Simvastatin 40mg, Ezetimibe/simvastatin 10/20 mg/day, Ezetimibe/simvastatin 10/40 mg/day
- Keywords
- Chronic kidney disease, Lipid lowering therapy, Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 40mgDrug
Simvastatin mono-therapy at the dose of 40 mg/day for 12 months
Ezetimibe/simvastatin 10/20 mg/dayDrug
Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months
Ezetimibe/simvastatin 10/40 mg/dayDrug
Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| simvastatin treatment | Active comparator | Not described Receives: Drug: Simvastatin 40mg |
| EZE/simvastatin 10/20 mg treatment | Sham comparator | Not described Receives: Drug: Ezetimibe/simvastatin 10/20 mg/day |
| EZE/simvastatin 10/40 mg treatment | Sham comparator | Not described Receives: Drug: Ezetimibe/simvastatin 10/40 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 4th, 8th and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start15 Jun 2018
- Primary completion15 Mar 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Sassari
- Responsible party
- Principal investigator, Duong Thi Ngoc Lan, Hue University of Medicine and Pharmacy
- Investigators
- Duong Thi Ngoc Lan, Master, Principal investigator, Hue University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543774
- Sponsor's protocol ID
- HueUMP
- Acronym
- VietCKD
- Status last verified
- Aug 2019
- First submitted
- 17 Apr 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38018702
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid-lowering Regimes Improve Oxidative Stress, Tryptophan Degradation in Hypercholesterolemia Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT03543774
- Acronym / sponsor ID
- VietCKD / HueUMP
- Conditions
- Hypercholesterolemia, Chronic Kidney Diseases
- Keywords
- Chronic kidney disease, Lipid lowering therapy, Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Università degli Studi di Sassari
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages Eligible for Study:
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 40mgSimvastatin mono-therapy at the dose of 40 mg/day for 12 months | Drug | simvastatin treatment |
| Ezetimibe/simvastatin 10/20 mg/dayEzetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months | Drug | EZE/simvastatin 10/20 mg treatment |
| Ezetimibe/simvastatin 10/40 mg/dayEzetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months | Drug | EZE/simvastatin 10/40 mg treatment |
Primary outcome
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
6 secondary outcomes
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
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
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
To measure the serum level of MDA in Vietnamese CKD population at 4th, 8th, 12th month.
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
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.
Time frame: at 4th, 8th and 12th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 38018702Tunnicliffe 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.
- A Trial of Pitavastatin Versus Rosuvastatin for Dyslipidemia in Chronic Kidney DiseaseLink provided by the sponsor.
- Effects of lowering LDL cholesterol on progression of kidney diseaseLink provided by the sponsor.
- Ezetimibe and simvastatin for the prevention of cardiovascular events in predialysis chronic kidney disease patients: a reviewLink provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duong Thi Ngoc Lan, Master principal investigator
Hue University of Medicine and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin 40mg, Ezetimibe/simvastatin 10/20 mg/day and Ezetimibe/simvastatin 10/40 mg/day in people with Hypercholesterolemia and Chronic Kidney Diseases, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duong Thi Ngoc Lan, Master (084-903572535, duongngoclan80@yahoo.com.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At the base time). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.