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

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

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

Study Overview

• Status: Unknown
• Conditions: Proteinuria; Chronic Kidney Disease
• Intervention / Treatment: Drug: Telmisartan/Rosuvastatin 40/10mg; Drug: Telmisartan 40mg

• Study Type: Interventional
• Enrollment (Anticipated): 374
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Not yet recruiting
    • Dong-A University Hospital
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Hospital
    • Contact: HwaYoung Lee; Phone Number: +82-53-200-6947; Email: dlghkdud1225@naver.com
    • Principal Investigator: SunHee Park, MD PhD
  • Daejeon, Korea, Republic of
    • Not yet recruiting
    • Chungnam national university hospital
    • Contact: SeongJin Hong; Phone Number: +82-42-280-6948; Email: hsj0674@cnuh.co.kr
    • Principal Investigator: DaeEun Choi, MD PhD
  • Goyang, Korea, Republic of
    • Recruiting
    • Inje University Ilsan Paik Hospital
    • Contact: HeeJaa Lee; Phone Number: +82-31-910-7776; Email: heejaalee@naver.com
    • Principal Investigator: Sang-Youb Han, MD PhD
  • Incheon, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea Incheon St.Mary's Hospital
    • Contact: SoonGuem Lee; Phone Number: +82-32-280-5188; Email: endo-zzang@daum.net
    • Principal Investigator: SeokJoon Shin, MD PhD
  • Jeonju, Korea, Republic of
    • Not yet recruiting
    • Presbyterian Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • SMG-SNU Boramae Medical Center
    • Contact: JiYoung Kim; Phone Number: +82-2-870-3875; Email: smile0212@daum.net
    • Principal Investigator: Chun Soo Lim, MD PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Hallym University Kangnam Sacred Heart Hospital
    • Contact: MiRan Choi; Phone Number: +82-2-829-5215; Email: hellocherry@hanmail.net
    • Principal Investigator: Young-Ki Lee, MD PhD
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • korea Universitiy Anam Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • KyungHee Universitiy Hospital at Gandong
    • Contact: JiHyun Kim; Phone Number: +82-2-440-7065; Email: cell41@naver.com
    • Principal Investigator: Ju Young MOON, MD PhD
  • Gangwon-do
    • Wŏnju, Gangwon-do, Korea, Republic of
      • Recruiting
      • WonJu Severance Christian Hospital
      • Contact: InJyung Kim; Phone Number: +82-33-749-0937; Email: noblessik@hanmail.net
      • Principal Investigator: ByungGeun Han, MD PhD
  • Gyeonggi-do
    • Anyang, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Hallym University Sacred Heart Hospital
      • Contact: SangMi Oh; Phone Number: +82-31-380-1770; Email: jinmi0320@gmail.com
      • Principal Investigator: Seong-Gyun Kim, MD PhD
    • Seongnam, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: HyunJin Cho; Phone Number: +82-31-787-7030; Email: 10871@snubh.org
      • Principal Investigator: Ki-Young Na, MD PhD
  • Gyeonggido
    • Ansan, Gyeonggido, Korea, Republic of
      • Recruiting
      • Korea University Ansan Hospital
      • Contact: SangMin Lee; Phone Number: +82-31-412-6764; Email: 3blue9@naver.com
      • Principal Investigator: DaeRyong Cha, MD PhD
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of
      • Recruiting
      • Chonbuk National University Hospital
      • Contact: YunJeong Chae; Phone Number: +82-63-250-1284; Email: cyj70105@hanmail.net
      • Principal Investigator: Wok Kim, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)	baseline, week 48

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2018
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: June 6, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Renal Insufficiency; Urination Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Rosuvastatin Calcium; Telmisartan
• Other Study ID Numbers: YMC030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No