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

Tanabe Pharma Corporation241 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

241

Conditions

Diabetic Nephropathy

Interventions

MT-3995 LowDRUG

MT-3995 MiddleDRUG

MT-3995 HighDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Touei Hospital

Hokkaido, Japan

Outcomes

Primary Outcomes

Adverse events

Time frame: From baseline to 28 weeks

Secondary Outcomes

Change from baseline in Urine Albumin to Creatinine Ratio (UACR)

Time frame: baseline and Week 28

Data from ClinicalTrials.gov

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