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Completed

NCT Number: NCT02517320

Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.

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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

Investigational site

Hokkaido, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus
  • Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5%
  • estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2
  • The median UACR of the first morning void urine samples is ≥50 mg/g Cr and <300 mg/g Cr
  • Stable blood pressure(diastolic blood pressure (DBP) <100 mmHg and stable systolic blood pressure (SBP) <160 mmHg)

Exclusion criteria

  • Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
  • A diagnosis of non-diabetic renal disease.
  • A following serum potassium level.
  • eGFR of 30-59mL/min/1.73m2; serum potassium level of <3.5 or >4.7 mmol/L,
  • eGFR of ≥60mL/min/1.73m2: serum potassium level of <3.5 or >5.0 mmol/L
  • symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)<50mmHg and systolic blood pressure(SBP)<110mmHg)
  • QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes
  • New York Heart Association (NYHA) Class III or IV heart failure

Treatment and study plan

MT-3995 Low

Drug

MT-3995 Middle

Drug

MT-3995 High

Drug

Placebo

Drug

Primary outcomes

  1. Change form baseline in UACR

    Time frame: Week 24

Secondary outcomes

  1. Change in UACR classification

    Time frame: From baseline to 24 weeks

  2. Change in renal function

    Time frame: From baseline to 24 weeks

  3. Change in serum potassium

    Time frame: From baseline to 24 weeks

  4. Adverse events

    Time frame: From baseline to 24 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Aug 7, 2015
Registry last updated
Mar 3, 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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