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

Phase 1

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: Placebo; Drug: MT-3995

• Registration Number: NCT02205372
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-27
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
MT-3995	MT-3995	-

Primary Outcome Measures

Name	Time	Method
Frequency and nature of treatment-emergent adverse events and serious adverse events.	20 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of MT-3995	20 weeks
Plasma concentrations of major metabolite of MT-3995	20 weeks
Change from baseline in Urine albumin-to-creatinine ratio (UACR)	20 weeks
Change from baseline in blood pressure	20 weeks

Trial Locations

Locations (1)

Touei Hospital; 🇯🇵 Sapporo, Hokkaido, Japan