Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy
NCT ID: NCT02205372
Last Updated: 2015-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
31 participants
INTERVENTIONAL
2014-07-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MT-3995
MT-3995
Placebo
Placebo
Interventions
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MT-3995
Placebo
Eligibility Criteria
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Inclusion Criteria
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* Subject with albuminuria
Exclusion Criteria
* 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
20 Years
75 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Masaomi Nangaku, Professor
Role: STUDY_DIRECTOR
Division of Nephrology and Endocrinology University of Tokyo School of medicine
Kazuoki Kondou, Adviser
Role: STUDY_DIRECTOR
Mitsubishi Tanabe Pharma Corporation
Locations
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Touei Hospital
Sapporo, Hokkaido, Japan
Countries
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Other Identifiers
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MT-3995-J04
Identifier Type: -
Identifier Source: org_study_id
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