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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02676401

Enrollment

241

Registered

2016-02-08

Start date

2016-02-29

Completion date

Unknown

Last updated

2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy

Brief summary

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

Interventions

DRUGMT-3995 Low

DRUGMT-3995 Middle

DRUGMT-3995 High

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events	From baseline to 28 weeks

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026