Back to resultsHMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
Primary Purpose
Chronic Kidney Disease, Proteinuria
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Telmisartan/Rosuvastatin 40/10mg
Telmisartan 40mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 19 years
- Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
- Diagnosed with hypertension
- Written informed consent
- Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization
Exclusion Criteria:
- Type I diabetes
- Uncontrolled diabetic patients with HbA1c > 10% at screening
- 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
- Calculated LDL-C ≥ 160 mg/dL at randomization
- Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
- Heart failure patients with NYHA class IV
- Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
- 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)
- Patients taking immunosuppressive drugs
- Patients undergoing eGFR <30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
- Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
- Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
- Patients who are pregnant or planning to become pregnant
- Contraindications stated in the SPC of telmisartan or rosuvastatin
- Those participating in other clinical trials for investigational products at screening
- Patients deemed to be ineligible to participate in the trial by investigator
Sites / Locations
- Wonju Severance Christian HospitalRecruiting
- Hallym University Sacred Heart HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Korea University Ansan HospitalRecruiting
- Chonbuk National University HospitalRecruiting
- Dong-A University Hospital
- Kyungpook National University HospitalRecruiting
- Chungnam National University Hospital
- Inje University Ilsan Paik HospitalRecruiting
- The Catholic University of Korea Incheon St.Mary's HospitalRecruiting
- Presbyterian Medical Center
- Gangnam Severance Hospital
- Hallym University Kangnam Sacred Heart HospitalRecruiting
- korea Universitiy Anam Hospital
- KyungHee Universitiy Hospital at GandongRecruiting
- SMG-SNU Boramae Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Duowell Tab. 40/10mg
Micardis Tab. 40mg
Arm Description
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Telmisartan 40mg qd for 48 weeks
Outcomes
Primary Outcome Measures
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
Secondary Outcome Measures
Change from baseline to week 24 in UPCR
Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)
Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)
Change from baseline to week 48 in UPCR
Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)
Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)
Change from baseline to week 48 in 24hr urine protein
Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks
Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)
Change from baseline to week 48 in urinary 8-isoprostane
Change from baseline to week 48 in urine nephrin
Change from baseline to week 48 in type IV collagen
Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03550859
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
374 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Duowell Tab. 40/10mg
Arm Type
Experimental
Arm Description
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Arm Title
Micardis Tab. 40mg
Arm Type
Active Comparator
Arm Description
Telmisartan 40mg qd for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Telmisartan/Rosuvastatin 40/10mg
Intervention Description
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Telmisartan 40mg
Intervention Description
Telmisartan 40mg qd for 48 weeks
Primary Outcome Measure Information:
Title
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
Time Frame
baseline, week 48
Secondary Outcome Measure Information:
Title
Change from baseline to week 24 in UPCR
Time Frame
baseline, week 24
Title
Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)
Time Frame
baseline, week 24, week 48
Title
Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)
Time Frame
baseline, week 24, week 48
Title
Change from baseline to week 48 in UPCR
Time Frame
baseline, week 48
Title
Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)
Time Frame
baseline, week 48
Title
Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)
Time Frame
baseline, week 48
Title
Change from baseline to week 48 in 24hr urine protein
Time Frame
baseline, week 48
Title
Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks
Time Frame
baseline, week 48
Title
Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)
Time Frame
baseline, week 48
Title
Change from baseline to week 48 in urinary 8-isoprostane
Time Frame
baseline, week 48
Title
Change from baseline to week 48 in urine nephrin
Time Frame
baseline, week 48
Title
Change from baseline to week 48 in type IV collagen
Time Frame
baseline, week 48
Title
Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks
Time Frame
baseline, week 12, week 24, week 36, week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 19 years
Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
Diagnosed with hypertension
Written informed consent
Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization
Exclusion Criteria:
Type I diabetes
Uncontrolled diabetic patients with HbA1c > 10% at screening
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
Calculated LDL-C ≥ 160 mg/dL at randomization
Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
Heart failure patients with NYHA class IV
Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
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)
Patients taking immunosuppressive drugs
Patients undergoing eGFR <30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
Patients who are pregnant or planning to become pregnant
Contraindications stated in the SPC of telmisartan or rosuvastatin
Those participating in other clinical trials for investigational products at screening
Patients deemed to be ineligible to participate in the trial by investigator
Facility Information:
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
State/Province
Gangwon-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
InJyung Kim
Phone
+82-33-749-0937
Email
noblessik@hanmail.net
First Name & Middle Initial & Last Name & Degree
ByungGeun Han, MD PhD
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SangMi Oh
Phone
+82-31-380-1770
Email
jinmi0320@gmail.com
First Name & Middle Initial & Last Name & Degree
Seong-Gyun Kim, MD PhD
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HyunJin Cho
Phone
+82-31-787-7030
Email
10871@snubh.org
First Name & Middle Initial & Last Name & Degree
Ki-Young Na, MD PhD
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggido
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SangMin Lee
Phone
+82-31-412-6764
Email
3blue9@naver.com
First Name & Middle Initial & Last Name & Degree
DaeRyong Cha, MD PhD
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YunJeong Chae
Phone
+82-63-250-1284
Email
cyj70105@hanmail.net
First Name & Middle Initial & Last Name & Degree
Wok Kim, MD PhD
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HwaYoung Lee
Phone
+82-53-200-6947
Email
dlghkdud1225@naver.com
First Name & Middle Initial & Last Name & Degree
SunHee Park, MD PhD
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeongJin Hong
Phone
+82-42-280-6948
Email
hsj0674@cnuh.co.kr
First Name & Middle Initial & Last Name & Degree
DaeEun Choi, MD PhD
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HeeJaa Lee
Phone
+82-31-910-7776
Email
heejaalee@naver.com
First Name & Middle Initial & Last Name & Degree
Sang-Youb Han, MD PhD
Facility Name
The Catholic University of Korea Incheon St.Mary's Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SoonGuem Lee
Phone
+82-32-280-5188
Email
endo-zzang@daum.net
First Name & Middle Initial & Last Name & Degree
SeokJoon Shin, MD PhD
Facility Name
Presbyterian Medical Center
City
Jeonju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Hallym University Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MiRan Choi
Phone
+82-2-829-5215
Email
hellocherry@hanmail.net
First Name & Middle Initial & Last Name & Degree
Young-Ki Lee, MD PhD
Facility Name
korea Universitiy Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
KyungHee Universitiy Hospital at Gandong
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiHyun Kim
Phone
+82-2-440-7065
Email
cell41@naver.com
First Name & Middle Initial & Last Name & Degree
Ju Young MOON, MD PhD
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JiYoung Kim
Phone
+82-2-870-3875
Email
smile0212@daum.net
First Name & Middle Initial & Last Name & Degree
Chun Soo Lim, MD PhD
12. IPD Sharing Statement
Learn more about this trial
HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
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