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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02676401
Recruitment Status : Completed
First Posted : February 8, 2016
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: MT-3995 Low Drug: MT-3995 Middle Drug: MT-3995 High Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2016
Actual Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Adverse events [ Time Frame: From baseline to 28 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Urine Albumin to Creatinine Ratio (UACR) [ Time Frame: baseline and Week 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02676401

Touei Hospital
Hokkaido, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT02676401     History of Changes
Other Study ID Numbers: MT-3995-J06
First Posted: February 8, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diabetic Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases