Diabetic Nephropathy
Conditions
Keywords
Diabetic Nephropathy
Brief summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.
Interventions
DRUGMT-3995
DRUGPlacebo
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB) * Glycosylated haemoglobin (HbA1c) ≤10.5% * Subject with albuminuria
Exclusion criteria
* Subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus (Cushing's syndrome, steroidogenic diabetes). * Serum potassium level \<3.5 or \>5.0 mmol/L * Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation * Subjects with clinically significant hypotension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and nature of treatment-emergent adverse events and serious adverse events. | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of MT-3995 | 20 weeks |
| Plasma concentrations of major metabolite of MT-3995 | 20 weeks |
| Change from baseline in Urine albumin-to-creatinine ratio (UACR) | 20 weeks |
| Change from baseline in blood pressure | 20 weeks |
Countries
Japan
Outcome results
None listed