Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517320
• Other study ID #: MT-3995-J05
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2015
• Last updated: March 1, 2017
• Start date: July 2015
• Est. completion date: January 2017

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus

• Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program :

NGSP) =10.5%

• estimated glomerular filtration rate(eGFR) of =30 mL/min/1.73 m2

• The median UACR of the first morning void urine samples is =50 mg/g Cr and <300 mg/g Cr

• Stable blood pressure(diastolic blood pressure (DBP) <100 mmHg and stable systolic blood pressure (SBP) <160 mmHg)

Exclusion Criteria:

• Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.

• A diagnosis of non-diabetic renal disease.

• A following serum potassium level.

• eGFR of 30-59mL/min/1.73m2; serum potassium level of <3.5 or >4.7 mmol/L,

• eGFR of =60mL/min/1.73m2: serum potassium level of <3.5 or >5.0 mmol/L

• symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)<50mmHg and systolic blood pressure(SBP)<110mmHg)

• QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes

• New York Heart Association (NYHA) Class III or IV heart failure

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• MT-3995 Low

• MT-3995 Middle

• MT-3995 High

• Placebo

Locations

Country	Name	City	State
Japan	Investigational site	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	Change form baseline in UACR		Week 24
Secondary	Change in UACR classification		From baseline to 24 weeks
Secondary	Change in renal function		From baseline to 24 weeks
Secondary	Change in serum potassium		From baseline to 24 weeks
Secondary	Adverse events		From baseline to 24 weeks