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

Yuhan

Status and phase: Unknown; Phase 4

Conditions: Chronic Kidney Disease; Proteinuria

Treatments: Drug: Telmisartan 40mg; Drug: Telmisartan/Rosuvastatin 40/10mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03550859

YMC030

Details and patient eligibility

About

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

Enrollment: 374 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged ≥ 19 years
2. Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
3. Diagnosed with hypertension
4. Written informed consent
5. Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization

Exclusion criteria

1. Type I diabetes
2. Uncontrolled diabetic patients with HbA1c > 10% at screening
3. 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
4. Calculated LDL-C ≥ 160 mg/dL at randomization
5. Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
6. Heart failure patients with NYHA class IV
7. Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
8. 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)
9. Patients taking immunosuppressive drugs
10. Patients undergoing eGFR <30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
11. Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
12. Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
13. Patients who are pregnant or planning to become pregnant
14. Contraindications stated in the SPC of telmisartan or rosuvastatin
15. Those participating in other clinical trials for investigational products at screening
16. Patients deemed to be ineligible to participate in the trial by investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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374 participants in 2 patient groups

Duowell Tab. 40/10mg

Experimental group

Description:

Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks

Treatment:

Drug: Telmisartan/Rosuvastatin 40/10mg

Micardis Tab. 40mg

Active Comparator group

Description:

Telmisartan 40mg qd for 48 weeks

Treatment:

Drug: Telmisartan 40mg