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

September 15, 2017 updated by: Mitsubishi Tanabe Pharma Corporation
This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan
        • Touei Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT-3995 Low
Drug: MT-3995 Low
Experimental: MT-3995 Middle
Drug: MT-3995 Middle
Experimental: MT-3995 High
Drug: MT-3995 High

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: From baseline to 28 weeks
From baseline to 28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Urine Albumin to Creatinine Ratio (UACR)
Time Frame: baseline and Week 28
baseline and Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-3995-J06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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