An Extended Treatment Study of MT-3995 in Patients With D... | NCT02676401

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

NCT02676401

Sponsor

Tanabe Pharma Corporation

Status

Completed

Last Update Posted

Sep 18, 2017Actual

Enrollment

241Actual

Phase

Phase 2

Conditions

Diabetic Nephropathy

Interventions

MT-3995 Low
MT-3995 Middle
MT-3995 High

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Aug 2017Actual

Completion Date

Not provided

First Submitted Date

Feb 1, 2016

First Submission Date that Met QC Criteria

Feb 3, 2016

First Posted Date

Feb 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2017

Last Update Posted Date

Sep 18, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

241Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MT-3995 Low	Drug		MT-3995 Low
MT-3995 Middle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events		From baseline to 28 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32974732	Derived	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications