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Completed

NCT Number: NCT02676401

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

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

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Touei Hospital

Hokkaido, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-3995 Low

Drug

MT-3995 Middle

Drug

MT-3995 High

Drug

Primary outcomes

  1. Adverse events

    Time frame: From baseline to 28 weeks

Secondary outcomes

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

    Time frame: baseline and Week 28

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
First posted
Feb 8, 2016
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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