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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03550859
• Collaborator: (none)
• Enrollment: 374
• Locations: 16
• Arms: 2
• Anticipated Duration (Months): 41.9
• Patients Per Site: 23.4
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; Proteinuria	Drug: Telmisartan/Rosuvastatin 40/10mg; Drug: Telmisartan 40mg	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 374 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
• Actual Study Start Date: Jun 5, 2018
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duowell Tab. 40/10mg Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks	Drug: Telmisartan/Rosuvastatin 40/10mg; Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Active Comparator: Micardis Tab. 40mg Telmisartan 40mg qd for 48 weeks	Drug: Telmisartan 40mg; Telmisartan 40mg qd for 48 weeks

Outcome Measures

Primary Outcome Measures

1. Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR) [baseline, week 48]

Secondary Outcome Measures

1. Change from baseline to week 24 in UPCR [baseline, week 24]

2. Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR) [baseline, week 24, week 48]

3. Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR) [baseline, week 24, week 48]

4. Change from baseline to week 48 in UPCR [baseline, week 48]

5. Change from baseline to week 48 in high-sensitivity CRP (hs-CRP) [baseline, week 48]

6. Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR) [baseline, week 48]

7. Change from baseline to week 48 in 24hr urine protein [baseline, week 48]

8. Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks [baseline, week 48]

9. Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1) [baseline, week 48]

10. Change from baseline to week 48 in urinary 8-isoprostane [baseline, week 48]

11. Change from baseline to week 48 in urine nephrin [baseline, week 48]

12. Change from baseline to week 48 in type IV collagen [baseline, week 48]

13. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wonju Severance Christian Hospital	Wŏnju	Gangwon-do	Korea, Republic of
2	Hallym University Sacred Heart Hospital	Anyang	Gyeonggi-do	Korea, Republic of
3	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of
4	Korea University Ansan Hospital	Ansan	Gyeonggido	Korea, Republic of
5	Chonbuk National University Hospital	Jeonju	Jeollabuk-do	Korea, Republic of
6	Dong-A University Hospital	Busan		Korea, Republic of
7	Kyungpook National University Hospital	Daegu		Korea, Republic of
8	Chungnam National University Hospital	Daejeon		Korea, Republic of
9	Inje University Ilsan Paik Hospital	Goyang		Korea, Republic of
10	The Catholic University of Korea Incheon St.Mary's Hospital	Incheon		Korea, Republic of
11	Presbyterian Medical Center	Jeonju		Korea, Republic of
12	Gangnam Severance Hospital	Seoul		Korea, Republic of
13	Hallym University Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of
14	korea Universitiy Anam Hospital	Seoul		Korea, Republic of
15	KyungHee Universitiy Hospital at Gandong	Seoul		Korea, Republic of
16	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT03550859
• Other Study ID Numbers: YMC030
• First Posted: Jun 8, 2018
• Last Update Posted: Dec 14, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria; Telmisartan; Rosuvastatin Calcium

Study Results

No Results Posted as of Dec 14, 2020