The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
MT-3995 Low dose for 8 weeks
MT-3995 High dose for 8 weeks
Placebo for 8 weeks
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Time frame: up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time frame: up to 16 weeks
Percentage change from baseline in UACR compared to placebo
Time frame: up to 8 weeks
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
Time frame: up to 8 weeks
Plasma concentrations of MT-3995 and its major metabolite
Time frame: up to 16 weeks
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Investigational site
Blagoevgrad, Bulgaria
Investigational site
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
...and 33 more locations