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An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MT-3995 Low
MT-3995 Middle
MT-3995 High
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:

  • Written informed consent for participation before the completion of MT-3995-J05 Study
  • Completion of MT-3995-J05 study

Exclusion Criteria:

  • UACR of ≥300 mg/g Cr with an increase of ≥30% in MT-3995-J05 Study
  • Symptomatic and clinically significant hypotension
  • QT prolongation or torsades de pointes
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Patients who are judged to be unsuitable for participation based on their safety profile in MT-3995-J05 Study

Sites / Locations

  • Touei Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MT-3995 Low

MT-3995 Middle

MT-3995 High

Arm Description

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Change from baseline in Urine Albumin to Creatinine Ratio (UACR)

Full Information

First Posted
February 1, 2016
Last Updated
September 15, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02676401
Brief Title
An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
undefined (undefined)

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
This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.

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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-3995 Low
Arm Type
Experimental
Arm Title
MT-3995 Middle
Arm Type
Experimental
Arm Title
MT-3995 High
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MT-3995 Low
Intervention Type
Drug
Intervention Name(s)
MT-3995 Middle
Intervention Type
Drug
Intervention Name(s)
MT-3995 High
Primary Outcome Measure Information:
Title
Adverse events
Time Frame
From baseline to 28 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Urine Albumin to Creatinine Ratio (UACR)
Time Frame
baseline and Week 28

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: Written informed consent for participation before the completion of MT-3995-J05 Study Completion of MT-3995-J05 study Exclusion Criteria: UACR of ≥300 mg/g Cr with an increase of ≥30% in MT-3995-J05 Study Symptomatic and clinically significant hypotension QT prolongation or torsades de pointes New York Heart Association (NYHA) Class III or IV heart failure Patients who are judged to be unsuitable for participation based on their safety profile in MT-3995-J05 Study
Facility Information:
Facility Name
Touei Hospital
City
Hokkaido
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32974732
Citation
Wada T, Inagaki M, Yoshinari T, Terata R, Totsuka N, Gotou M, Hashimoto G. Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study. Clin Exp Nephrol. 2021 Feb;25(2):120-130. doi: 10.1007/s10157-020-01963-z. Epub 2020 Sep 24.
Results Reference
derived

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An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy

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