NCT02676401

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

1.5 years

First QC Date

February 1, 2016

Last Update Submit

September 15, 2017

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    From baseline to 28 weeks

Secondary Outcomes (1)

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

    baseline and Week 28

Study Arms (3)

MT-3995 Low

EXPERIMENTAL
Drug: MT-3995 Low

MT-3995 Middle

EXPERIMENTAL
Drug: MT-3995 Middle

MT-3995 High

EXPERIMENTAL
Drug: MT-3995 High

Interventions

MT-3995 LowDRUG
MT-3995 Low
MT-3995 MiddleDRUG
MT-3995 Middle
MT-3995 HighDRUG
MT-3995 High

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Touei Hospital

Hokkaido, Japan

Location

Related Publications (1)

  • 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.

    PMID: 32974732DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 8, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

JP(1)