Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Blagoevgrad | Bulgaria | ||||
| Investigational site |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Burgas |
| Bulgaria |
| Investigational site | Byala | Bulgaria |
| Investigational site | Golenci | Bulgaria |
| Investigational site | Pazardzhik | Bulgaria |
| Investigational site | Plovdiv | Bulgaria |
| Investigational site | Rousse | Bulgaria |
| Investigational site | Sofia | Bulgaria |
| Investigational site | Varna | Bulgaria |
| 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 | Kaunas | Lithuania |
| Investigational site | Klaipėda | Lithuania |
| Investigational site | Vilnius | Lithuania |
| Investigational site | Bacau | Romania |
| Investigational site | Baia Mare | Romania |
| Investigational site | Brasov | Romania |
| Investigational site | Brăila | Romania |
| Investigational site | Bucharest | Romania |
| Investigational site | Cluj-Napoca | Romania |
| Investigational site | Iași | Romania |
| Investigational site | Oradea | Romania |
| Investigational site | Ploieşti | Romania |
| Investigational site | Satu Mare | Romania |
| Investigational site | Târgu Mureş | Romania |
| Investigational site | Timișoara | Romania |
| Investigational site | Banská Bystrica | Slovakia |
| Investigational site | Bardejov | Slovakia |
| Investigational site | Bratislava | Slovakia |
| Investigational site | Lučenec | Slovakia |
| Investigational site | Martin | Slovakia |
| Investigational site | Nitra | Slovakia |
| Investigational site | Šahy | Slovakia |
| Investigational site | Štúrovo | Slovakia |
| Investigational site | Žilina | 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 |
Not provided
Not provided