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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2021
  • participants needed
    374
  • sponsor
    Yuhan Corporation
Updated on 26 January 2021
Investigator
YunJeong Chae
Primary Contact
Chonbuk National University Hospital (0.0 mi away) Contact
+10 other location

Summary

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

Details
Condition chronic renal insufficiency, Chronic renal failure, Proteinuria, chronic kidney disease, chronic kidney disease (ckd)
Treatment Telmisartan 40mg, Telmisartan/Rosuvastatin 40/10mg
Clinical Study IdentifierNCT03550859
SponsorYuhan Corporation
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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