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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-3995 Low | Experimental |
| |
| MT-3995 Middle | Experimental |
| |
| MT-3995 High | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-3995 Low | Drug |
| ||
| MT-3995 Middle |
| Measure | Description | Time Frame |
|---|---|---|
| Change form baseline in UACR | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UACR classification | From baseline to 24 weeks | |
| Change in renal function | From baseline to 24 weeks | |
| Change in serum potassium |
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Inclusion Criteria:
Exclusion Criteria:
Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
A diagnosis of non-diabetic renal disease.
A following serum potassium level.
symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)<50mmHg and systolic blood pressure(SBP)<110mmHg)
QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes
New York Heart Association (NYHA) Class III or IV heart failure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Hokkaido | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32974732 | Derived | 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. |
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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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|
| MT-3995 High | Drug |
|
| Placebo | Drug |
|
| From baseline to 24 weeks |
| Adverse events | From baseline to 24 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |