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The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and Moderately Decreased GFR
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-3995 Low group | Experimental |
| |
| MT-3995 High group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-3995 Low | Drug | MT-3995 Low dose for 8 weeks |
| |
| MT-3995 High |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group. | up to 8 weeks | |
| Frequency and nature of treatment-emergent adverse events and serious adverse events. | up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in UACR compared to placebo | up to 8 weeks | |
| Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group. | up to 8 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Blagoevgrad | Bulgaria | ||||
| Investigational site |
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| Drug |
MT-3995 High dose for 8 weeks |
|
| Placebo | Drug | Placebo for 8 weeks |
|
| Plasma concentrations of MT-3995 and its major metabolite |
| up to 16 weeks |
| Pazardzhik |
| Bulgaria |
| Investigational site | Pleven | Bulgaria |
| Investigational site | Plovdiv | Bulgaria |
| Investigational site | Rousse | Bulgaria |
| Investigational site | Sofia | Bulgaria |
| Investigational site | Varna | Bulgaria |
| Investigational site | České Budějovice | Czechia |
| Investigational site | Český Krumlov | Czechia |
| Investigational site | Karlovy Vary | Czechia |
| Investigational site | Ostrava | Czechia |
| Investigational site | Ostrava-Vitkovice | Czechia |
| Investigational site | Prague | Czechia |
| Investigational site | Slaný | Czechia |
| Investigational site | Znojmo | Czechia |
| Investigational site | Baja | Hungary |
| Investigational site | Budapest | Hungary |
| Investigational site | Debrecen | Hungary |
| Investigational site | Eger | Hungary |
| Investigational site | Kistelek | Hungary |
| Investigational site | Komárom | Hungary |
| Investigational site | Pécs | Hungary |
| Investigational site | Szigetvár | Hungary |
| Investigational site | Szikszó | Hungary |
| Investigational site | Zalaegerszeg | Hungary |
| Investigational site | Krakow | Poland |
| Investigational site | Ruda Śląska | Poland |
| Investigational site | Rzeszów | Poland |
| Investigational site | Świętochłowice | Poland |
| Investigational site | Bacau | Romania |
| Investigational site | Brăila | Romania |
| Investigational site | Bucharest | Romania |
| Investigational site | Buzău | Romania |
| Investigational site | Cluj-Napoca | Romania |
| Investigational site | Deva | Romania |
| Investigational site | Iași | Romania |
| Investigational site | Oradea | Romania |
| Investigational site | Ploiesti, Judet Prahova | Romania |
| Investigational site | Satu Mare | Romania |
| Investigational site | Târgu Mureş | Romania |
| Investigational site | Timișoara | Romania |
| Investigational site | Bardejov | Slovakia |
| Investigational site | Bratislava | Slovakia |
| Investigational site | Levice | Slovakia |
| Investigational site | Lučenec | Slovakia |
| Investigational site | Martin | Slovakia |
| Investigational site | Nitra | Slovakia |
| Investigational site | Prešov | Slovakia |
| Investigational site | Šahy | Slovakia |
| Investigational site | Štúrovo | Slovakia |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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