Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT01756703
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2012-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria
Sponsor:
Organization:
Raw JSON
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{'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-05', 'studyFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.', 'timeFrame': 'up to 8 weeks'}, {'measure': 'Frequency and nature of treatment-emergent adverse events and serious adverse events.', 'timeFrame': 'up to 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage change from baseline in UACR compared to placebo', 'timeFrame': 'up to 8 weeks'}, {'measure': 'Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.', 'timeFrame': 'up to 8 weeks'}, {'measure': 'Plasma concentrations of MT-3995 and its major metabolite', 'timeFrame': 'up to 16 weeks'}]}, 'conditionsModule': {'keywords': ['Diabetic Nephropathy'], 'conditions': ['Diabetic Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)\n* Glycosylated haemoglobin (HbA1c) ≤10.5%\n* An estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\\^2\n* Subject with albuminuria\n\nExclusion Criteria:\n\n* History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy\n* Serum potassium level \\<3.5 or \\>5.0 mmol/L\n* Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation\n* Subjects with a history of renal transplant\n* Subjects with clinically significant hypotension'}, 'identificationModule': {'nctId': 'NCT01756703', 'briefTitle': 'A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2', 'orgStudyIdInfo': {'id': 'MT-3995-E06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-3995 Low group', 'interventionNames': ['Drug: MT-3995 Low']}, {'type': 'EXPERIMENTAL', 'label': 'MT-3995 High group', 'interventionNames': ['Drug: MT-3995 High']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MT-3995 Low', 'type': 'DRUG', 'description': 'MT-3995 Low dose for 8 weeks', 'armGroupLabels': ['MT-3995 Low group']}, {'name': 'MT-3995 High', 'type': 'DRUG', 'description': 'MT-3995 High dose for 8 weeks', 'armGroupLabels': ['MT-3995 High group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for 8 weeks', 'armGroupLabels': ['Placebo group']}]}, 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