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| Name | Class |
|---|---|
| Università degli Studi di Sassari | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simvastatin treatment | Active Comparator |
| |
| EZE/simvastatin 10/20 mg treatment | Sham Comparator |
| |
| EZE/simvastatin 10/40 mg treatment | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 40mg | Drug | Simvastatin mono-therapy at the dose of 40 mg/day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 4th, 8th and 12th month |
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Inclusion Criteria:
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)
Exclusion Criteria:
In adults with dialysis-dependent CKD
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Duong Thi Ngoc Lan, Master | Contact | 084-903572535 | duongngoclan80@yahoo.com.vn | |
| Ciriaco Carru, Professor | Contact | 0039-3204299322 | carru@uniss.it |
| Name | Affiliation | Role |
|---|---|---|
| Duong Thi Ngoc Lan, Master | Hue University of Medicine and Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hue University of Medicine and Pharmacy | Recruiting | Huế | Thừa Thiên Huế Province | 0234 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38018702 | Derived | 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. |
| Label | URL |
|---|---|
| A Trial of Pitavastatin Versus Rosuvastatin for Dyslipidemia in Chronic Kidney Disease | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2018 | May 6, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 5, 2018 | May 6, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2018 | May 6, 2018 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Ezetimibe/simvastatin 10/20 mg/day | Drug | Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months |
|
| Ezetimibe/simvastatin 10/40 mg/day | Drug | Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months |
|
| 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 | 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 | 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 | 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 | 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 | at 4th, 8th and 12th month |
| Effects of lowering LDL cholesterol on progression of kidney disease | View source |
| Ezetimibe and simvastatin for the prevention of cardiovascular events in predialysis chronic kidney disease patients: a review | View source |
| 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. | View source |
| D009750 |
| Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |