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

Chronic Kidney Disease Clinical Trial

Official title:

Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03550859
• Other study ID #: YMC030
• Status: Recruiting
• Phase: Phase 4
• Start date: June 5, 2018
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 374
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Proteinuria
• Renal Insufficiency, Chronic

Intervention

Drug:
• Telmisartan/Rosuvastatin 40/10mg
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
• Telmisartan 40mg
Telmisartan 40mg qd for 48 weeks

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan	Gyeonggido
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeonggi-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	Chonbuk National University Hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	korea Universitiy Anam Hospital	Seoul
Korea, Republic of	KyungHee Universitiy Hospital at Gandong	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)		baseline, week 48
Secondary	Change from baseline to week 24 in UPCR		baseline, week 24
Secondary	Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)		baseline, week 24, week 48
Secondary	Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)		baseline, week 24, week 48
Secondary	Change from baseline to week 48 in UPCR		baseline, week 48
Secondary	Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)		baseline, week 48
Secondary	Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)		baseline, week 48
Secondary	Change from baseline to week 48 in 24hr urine protein		baseline, week 48
Secondary	Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks		baseline, week 48
Secondary	Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)		baseline, week 48
Secondary	Change from baseline to week 48 in urinary 8-isoprostane		baseline, week 48
Secondary	Change from baseline to week 48 in urine nephrin		baseline, week 48
Secondary	Change from baseline to week 48 in type IV collagen		baseline, week 48
Secondary	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