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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 2

Conditions: Diabetic Nephropathy

Treatments: Drug: MT-3995 Middle; Drug: MT-3995 Low; Drug: MT-3995 High

Study type: Interventional

Funder types: Industry

Identifiers

NCT02676401

MT-3995-J06

Details and patient eligibility

About

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

Enrollment: 241 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 3 patient groups

MT-3995 Low

Experimental group

Treatment:

Drug: MT-3995 Low

MT-3995 Middle

Experimental group

Treatment:

Drug: MT-3995 Middle

MT-3995 High

Experimental group

Treatment:

Drug: MT-3995 High