Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 (Low Dose) in Subjects With Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02205372
• Other study ID #: MT-3995-J04
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 27, 2014
• Last updated: September 14, 2015
• Start date: July 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)

• Glycosylated haemoglobin (HbA1c) =10.5%

• Subject with albuminuria

Exclusion Criteria:

• Subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus (Cushing's syndrome, steroidogenic diabetes).

• Serum potassium level <3.5 or >5.0 mmol/L

• Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation

• Subjects with clinically significant hypotension

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• MT-3995

• Placebo

Locations

Country	Name	City	State
Japan	Touei Hospital	Sapporo	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	Frequency and nature of treatment-emergent adverse events and serious adverse events.		20 weeks	Yes
Secondary	Plasma concentrations of MT-3995		20 weeks	No
Secondary	Plasma concentrations of major metabolite of MT-3995		20 weeks	No
Secondary	Change from baseline in Urine albumin-to-creatinine ratio (UACR)		20 weeks	No
Secondary	Change from baseline in blood pressure		20 weeks	No