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

Phase 4

• Conditions: Chronic Kidney Disease; Proteinuria
• Interventions: Drug: Telmisartan 40mg; Drug: Telmisartan/Rosuvastatin 40/10mg

• Registration Number: NCT03550859
• Lead Sponsor: Yuhan Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-09
• Study Start: 2018-06-05
• Study First Submitted QC: 2018-06-06
• Study First Posted: 2018-06-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 374

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Micardis Tab. 40mg	Telmisartan 40mg	Telmisartan 40mg qd for 48 weeks
Duowell Tab. 40/10mg	Telmisartan/Rosuvastatin 40/10mg	Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks

Primary Outcome Measures

Name	Time	Method
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)	baseline, week 48

Secondary Outcome Measures

Name	Time	Method
Change from baseline to week 48 in urine nephrin	baseline, week 48
Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks	baseline, week 48
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 48 in UPCR	baseline, week 48
Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)	baseline, week 48
Change from baseline to week 24 in UPCR	baseline, week 24
Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)	baseline, week 48
Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)	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
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 24hr urine protein	baseline, week 48
Change from baseline to week 48 in urinary 8-isoprostane	baseline, week 48
Change from baseline to week 48 in type IV collagen	baseline, week 48

Trial Locations

Locations (16)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Goyang, Korea, Republic of

The Catholic University of Korea Incheon St.Mary's Hospital; 🇰🇷 Incheon, Korea, Republic of

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

korea Universitiy Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan, Gyeonggido, Korea, Republic of

Hallym University Kangnam Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wŏnju, Gangwon-do, Korea, Republic of

KyungHee Universitiy Hospital at Gandong; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of