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Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
MT-3995
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Touei Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-3995

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Frequency and nature of treatment-emergent adverse events and serious adverse events.

Secondary Outcome Measures

Plasma concentrations of MT-3995
Plasma concentrations of major metabolite of MT-3995
Change from baseline in Urine albumin-to-creatinine ratio (UACR)
Change from baseline in blood pressure

Full Information

First Posted
July 27, 2014
Last Updated
September 14, 2015
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02205372
Brief Title
Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy
Official Title
A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 (Low Dose) in Subjects With Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Diabetic Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-3995
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MT-3995
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Plasma concentrations of MT-3995
Time Frame
20 weeks
Title
Plasma concentrations of major metabolite of MT-3995
Time Frame
20 weeks
Title
Change from baseline in Urine albumin-to-creatinine ratio (UACR)
Time Frame
20 weeks
Title
Change from baseline in blood pressure
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaomi Nangaku, Professor
Organizational Affiliation
Division of Nephrology and Endocrinology University of Tokyo School of medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondou, Adviｓer
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Touei Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy

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