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Clinical Trials/NCT02676401
NCT02676401
Completed
Phase 2

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

Mitsubishi Tanabe Pharma Corporation1 site in 1 country241 target enrollmentFebruary 2016
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ConditionsDiabetic Nephropathy
InterventionsMT-3995 LowMT-3995 MiddleMT-3995 High
DrugsMT-3995 LowMT-3995 MiddleMT-3995 High

Overview

Phase
Phase 2
Intervention
MT-3995 Low
Conditions
Diabetic Nephropathy
Sponsor
Mitsubishi Tanabe Pharma Corporation
Enrollment
241
Locations
1
Primary Endpoint
Adverse events
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

MT-3995 Low

Intervention: MT-3995 Low

MT-3995 Middle

Intervention: MT-3995 Middle

MT-3995 High

Intervention: MT-3995 High

Outcomes

Primary Outcomes

Adverse events

Time Frame: From baseline to 28 weeks

Secondary Outcomes

  • Change from baseline in Urine Albumin to Creatinine Ratio (UACR)(baseline and Week 28)

Study Sites (1)

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