HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria

Study Overview
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Brief Summary
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This study is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria.

Official Title
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Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria

Conditions
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Chronic Kidney Disease, Proteinuria

Intervention / Treatment
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* Drug: Telmisartan/Rosuvastatin 40/10mg
* Drug: Telmisartan 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥ 19 years Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g Diagnosed with hypertension Written informed consent Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization Exclusion Criteria: Type I diabetes Uncontrolled diabetic patients with HbA1c > 10% at screening Hypertensive patients whose mean blood pressure was not controlled at 160/90 mmHg or more in triplicate despite the use of antihypertensive agents at the time of randomization Calculated LDL-C ≥ 160 mg/dL at randomization Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization Heart failure patients with NYHA class IV Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months Patients with a history of cerebral blood cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, and percutaneous coronary intervention) Patients taking immunosuppressive drugs Patients undergoing eGFR <30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range) Patients who are pregnant or planning to become pregnant Contraindications stated in the SPC of telmisartan or rosuvastatin Those participating in other clinical trials for investigational products at screening Patients deemed to be ineligible to participate in the trial by investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duowell Tab. 40/10mg<br>Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks | Drug: Telmisartan/Rosuvastatin 40/10mg<br>* Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks<br>|
| Active Comparator: Micardis Tab. 40mg<br>Telmisartan 40mg qd for 48 weeks | Drug: Telmisartan 40mg<br>* Telmisartan 40mg qd for 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR) |  | baseline, week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 24 in UPCR |  | baseline, week 24 | 
| Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR) |  | baseline, week 24, week 48 | 
| Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR) |  | baseline, week 24, week 48 | 
| Change from baseline to week 48 in UPCR |  | baseline, week 48 | 
| Change from baseline to week 48 in high-sensitivity CRP (hs-CRP) |  | baseline, week 48 | 
| Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR) |  | baseline, week 48 | 
| Change from baseline to week 48 in 24hr urine protein |  | baseline, week 48 | 
| Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks |  | baseline, week 48 | 
| Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1) |  | baseline, week 48 | 
| Change from baseline to week 48 in urinary 8-isoprostane |  | baseline, week 48 | 
| Change from baseline to week 48 in urine nephrin |  | baseline, week 48 | 
| Change from baseline to week 48 in type IV collagen |  | baseline, week 48 | 
| Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks |  | baseline, week 12, week 24, week 36, week 48 |