HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
NCT ID: NCT03550859
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
374 participants
INTERVENTIONAL
2018-06-05
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Duowell Tab. 40/10mg
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Telmisartan/Rosuvastatin 40/10mg
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Micardis Tab. 40mg
Telmisartan 40mg qd for 48 weeks
Telmisartan 40mg
Telmisartan 40mg qd for 48 weeks
Interventions
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Telmisartan/Rosuvastatin 40/10mg
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
Telmisartan 40mg
Telmisartan 40mg qd for 48 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Korea University Ansan Hospital
Ansan, Gyeonggido, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Inje University Ilsan Paik Hospital
Goyang, , South Korea
The Catholic University of Korea Incheon St.Mary's Hospital
Incheon, , South Korea
Presbyterian Medical Center
Jeonju, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
korea Universitiy Anam Hospital
Seoul, , South Korea
KyungHee Universitiy Hospital at Gandong
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Countries
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Facility Contacts
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InJyung Kim
Role: primary
SangMi Oh
Role: primary
HyunJin Cho
Role: primary
SangMin Lee
Role: primary
YunJeong Chae
Role: primary
HwaYoung Lee
Role: primary
SeongJin Hong
Role: primary
HeeJaa Lee
Role: primary
SoonGuem Lee
Role: primary
MiRan Choi
Role: primary
JiHyun Kim
Role: primary
JiYoung Kim
Role: primary
Other Identifiers
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YMC030
Identifier Type: -
Identifier Source: org_study_id