Clinical trial NCT03550859: HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
Official title: Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Proteinuria
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 374
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
timeFrame: baseline, week 48
Secondary outcomes:
measure: Change from baseline to week 24 in UPCR
timeFrame: baseline, week 24
measure: Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)
timeFrame: baseline, week 24, week 48
measure: Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)
timeFrame: baseline, week 24, week 48
measure: Change from baseline to week 48 in UPCR
timeFrame: baseline, week 48
measure: Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)
timeFrame: baseline, week 48
measure: Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)
timeFrame: baseline, week 48
measure: Change from baseline to week 48 in 24hr urine protein
timeFrame: baseline, week 48
measure: Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks
timeFrame: baseline, week 48
measure: Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)
timeFrame: baseline, week 48
measure: Change from baseline to week 48 in urinary 8-isoprostane
timeFrame: baseline, week 48
measure: Change from baseline to week 48 in urine nephrin
timeFrame: baseline, week 48
measure: Change from baseline to week 48 in type IV collagen
timeFrame: baseline, week 48
measure: Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks
timeFrame: baseline, week 12, week 24, week 36, week 48
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggido
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St.Mary's Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: korea Universitiy Anam Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee Universitiy Hospital at Gandong
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References: