Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-03-08 @ 1:54 AM
Study NCT ID:
NCT03550859
Status:
UNKNOWN
Last Update Posted:
2020-12-14
First Post:
2018-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077333', 'term': 'Telmisartan'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 374}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2018-05-09', 'studyFirstSubmitQcDate': '2018-06-06', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)', 'timeFrame': 'baseline, week 48'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease', 'Proteinuria']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged ≥ 19 years\n2. Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g\n3. Diagnosed with hypertension\n4. Written informed consent\n5. Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization\n\nExclusion Criteria:\n\n1. Type I diabetes\n2. Uncontrolled diabetic patients with HbA1c \\> 10% at screening\n3. 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\n4. Calculated LDL-C ≥ 160 mg/dL at randomization\n5. Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization\n6. Heart failure patients with NYHA class IV\n7. Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months\n8. 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)\n9. Patients taking immunosuppressive drugs\n10. Patients undergoing eGFR \\<30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening\n11. Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening\n12. Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)\n13. Patients who are pregnant or planning to become pregnant\n14. Contraindications stated in the SPC of telmisartan or rosuvastatin\n15. Those participating in other clinical trials for investigational products at screening\n16. Patients deemed to be ineligible to participate in the trial by investigator'}, 'identificationModule': {'nctId': 'NCT03550859', 'briefTitle': 'HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': 'Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria', 'orgStudyIdInfo': {'id': 'YMC030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duowell Tab. 40/10mg', 'description': 'Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks', 'interventionNames': ['Drug: Telmisartan/Rosuvastatin 40/10mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Micardis Tab. 40mg', 'description': 'Telmisartan 40mg qd for 48 weeks', 'interventionNames': ['Drug: Telmisartan 40mg']}], 'interventions': [{'name': 'Telmisartan/Rosuvastatin 40/10mg', 'type': 'DRUG', 'description': 'Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks', 'armGroupLabels': ['Duowell Tab. 40/10mg']}, {'name': 'Telmisartan 40mg', 'type': 'DRUG', 'description': 'Telmisartan 40mg qd for 48 weeks', 'armGroupLabels': ['Micardis Tab. 40mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wŏnju', 'state': 'Gangwon-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'InJyung Kim', 'role': 'CONTACT', 'email': 'noblessik@hanmail.net', 'phone': '+82-33-749-0937'}, {'name': 'ByungGeun Han, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}, {'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SangMi Oh', 'role': 'CONTACT', 'email': 'jinmi0320@gmail.com', 'phone': '+82-31-380-1770'}, {'name': 'Seong-Gyun Kim, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'HyunJin Cho', 'role': 'CONTACT', 'email': '10871@snubh.org', 'phone': '+82-31-787-7030'}, {'name': 'Ki-Young Na, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Ansan', 'state': 'Gyeonggido', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SangMin Lee', 'role': 'CONTACT', 'email': '3blue9@naver.com', 'phone': '+82-31-412-6764'}, {'name': 'DaeRyong Cha, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'city': 'Jeonju', 'state': 'Jeollabuk-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'YunJeong Chae', 'role': 'CONTACT', 'email': 'cyj70105@hanmail.net', 'phone': '+82-63-250-1284'}, {'name': 'Wok Kim, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Busan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'HwaYoung Lee', 'role': 'CONTACT', 'email': 'dlghkdud1225@naver.com', 'phone': '+82-53-200-6947'}, {'name': 'SunHee Park, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SeongJin Hong', 'role': 'CONTACT', 'email': 'hsj0674@cnuh.co.kr', 'phone': '+82-42-280-6948'}, {'name': 'DaeEun Choi, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Goyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'HeeJaa Lee', 'role': 'CONTACT', 'email': 'heejaalee@naver.com', 'phone': '+82-31-910-7776'}, {'name': 'Sang-Youb Han, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Inje University Ilsan Paik Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'SoonGuem Lee', 'role': 'CONTACT', 'email': 'endo-zzang@daum.net', 'phone': '+82-32-280-5188'}, {'name': 'SeokJoon Shin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Catholic University of Korea Incheon St.Mary's Hospital", 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeonju', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Presbyterian Medical Center', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'MiRan Choi', 'role': 'CONTACT', 'email': 'hellocherry@hanmail.net', 'phone': '+82-2-829-5215'}, {'name': 'Young-Ki Lee, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hallym University Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'facility': 'korea Universitiy Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JiHyun Kim', 'role': 'CONTACT', 'email': 'cell41@naver.com', 'phone': '+82-2-440-7065'}, {'name': 'Ju Young MOON, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'KyungHee Universitiy Hospital at Gandong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JiYoung Kim', 'role': 'CONTACT', 'email': 'smile0212@daum.net', 'phone': '+82-2-870-3875'}, {'name': 'Chun Soo Lim, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SMG-SNU Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}