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

NCT ID: NCT02676401

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Brief Summary

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

Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MT-3995 Low

Group Type EXPERIMENTAL

MT-3995 Low

Intervention Type DRUG

MT-3995 Middle

Group Type EXPERIMENTAL

MT-3995 Middle

Intervention Type DRUG

MT-3995 High

Group Type EXPERIMENTAL

MT-3995 High

Intervention Type DRUG

Interventions

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MT-3995 Low

Intervention Type DRUG

MT-3995 Middle

Intervention Type DRUG

MT-3995 High

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Touei Hospital

Hokkaido, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 32974732 (View on PubMed)

Other Identifiers

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MT-3995-J06

Identifier Type: -

Identifier Source: org_study_id