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The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-3995-Low | Experimental | MT-3995-Low Dose |
|
| MT-3995-High | Experimental | MT-3995-High Dose |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-3995-Low | Drug |
| ||
| MT-3995-High |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and nature of treatment-emergent adverse events and serious adverse events. | 20 weeks | |
| Plasma concentrations of MT-3995 and its major metabolite | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure | 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masaomi Nangaku, Professor | Division of Nephrology and Endocrinology University of Tokyo School of medicine | Study Director |
| Kazuoki Kondou, Adviser | Tanabe Pharma Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koukan Hospital | Kawasaki | Kanagawa Pref. | Japan |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| Placebo | Drug |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |