Overview

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

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yuhan Corporation

Treatments:

Rosuvastatin Calcium
Telmisartan

Criteria

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