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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-08-31

Brief Summary

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The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.

Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MT-3995

Group Type EXPERIMENTAL

MT-3995

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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MT-3995

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Japan

Other Identifiers

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MT-3995-J04

Identifier Type: -

Identifier Source: org_study_id

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