Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-05 @ 6:09 PM
Study NCT ID:
NCT02517320
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change form baseline in UACR', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': 'Change in UACR classification', 'timeFrame': 'From baseline to 24 weeks'}, {'measure': 'Change in renal function', 'timeFrame': 'From baseline to 24 weeks'}, {'measure': 'Change in serum potassium', 'timeFrame': 'From baseline to 24 weeks'}, {'measure': 'Adverse events', 'timeFrame': 'From baseline to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic Nephropathy'], 'conditions': ['Diabetic Nephropathy']}, 'referencesModule': {'references': [{'pmid': '32974732', 'type': 'DERIVED', 'citation': 'Wada T, Inagaki M, Yoshinari T, Terata R, Totsuka N, Gotou M, Hashimoto G. Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study. Clin Exp Nephrol. 2021 Feb;25(2):120-130. doi: 10.1007/s10157-020-01963-z. Epub 2020 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5%\n* estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2\n* The median UACR of the first morning void urine samples is ≥50 mg/g Cr and \\<300 mg/g Cr\n* Stable blood pressure(diastolic blood pressure (DBP) \\<100 mmHg and stable systolic blood pressure (SBP) \\<160 mmHg)\n\nExclusion Criteria:\n\n* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.\n* A diagnosis of non-diabetic renal disease.\n* A following serum potassium level.\n\n * eGFR of 30-59mL/min/1.73m2; serum potassium level of \\<3.5 or \\>4.7 mmol/L,\n * eGFR of ≥60mL/min/1.73m2: serum potassium level of \\<3.5 or \\>5.0 mmol/L\n* symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)\\<50mmHg and systolic blood pressure(SBP)\\<110mmHg)\n* QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes\n* New York Heart Association (NYHA) Class III or IV heart failure'}, 'identificationModule': {'nctId': 'NCT02517320', 'briefTitle': 'Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy', 'orgStudyIdInfo': {'id': 'MT-3995-J05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-3995 Low', 'interventionNames': ['Drug: MT-3995 Low']}, {'type': 'EXPERIMENTAL', 'label': 'MT-3995 Middle', 'interventionNames': ['Drug: MT-3995 Middle']}, {'type': 'EXPERIMENTAL', 'label': 'MT-3995 High', 'interventionNames': ['Drug: MT-3995 High']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MT-3995 Low', 'type': 'DRUG', 'armGroupLabels': ['MT-3995 Low']}, {'name': 'MT-3995 Middle', 'type': 'DRUG', 'armGroupLabels': ['MT-3995 Middle']}, {'name': 'MT-3995 High', 'type': 'DRUG', 'armGroupLabels': ['MT-3995 High']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Investigational site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}