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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
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
Pazardzhik, Bulgaria
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Pleven, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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České Budějovice, Czechia
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Český Krumlov, Czechia
Investigational site
Karlovy Vary, Czechia
...and 40 more locations