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

Diabetic Nephropathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676401
• Other study ID #: MT-3995-J06
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2016
• Last updated: September 15, 2017
• Start date: February 2016

Study information

• Verified date: September 2017
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• MT-3995 Low

• MT-3995 Middle

• MT-3995 High

Locations

Country	Name	City	State
Japan	Touei Hospital	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		From baseline to 28 weeks
Secondary	Change from baseline in Urine Albumin to Creatinine Ratio (UACR)		baseline and Week 28