Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02205372
Start Date
July 1 2014
End Date
August 1 2015
Last Update
September 16 2015
Active Locations (1)
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1
Touei Hospital
Sapporo, Hokkaido, Japan