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

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: MT-3995 High; Drug: MT-3995 Low; Drug: MT-3995 Middle

• Registration Number: NCT02676401
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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 available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Primary Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-3995 High	MT-3995 High	-
MT-3995 Low	MT-3995 Low	-
MT-3995 Middle	MT-3995 Middle	-

Primary Outcome Measures

Name	Time	Method
Adverse events	From baseline to 28 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Touei Hospital; 🇯🇵 Hokkaido, Japan