A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR

Phase 2

Completed

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

• Registration Number: NCT01756716
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and Moderately Decreased GFR

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-20
• Study First Posted: 2012-12-27
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-05
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
• Glycosylated haemoglobin (HbA1c) ≤10.5%
• An estimated glomerular filtration rate (eGFR) ≥30-<60 mL/min/1.73m^2
• Subject with albuminuria

Exclusion Criteria

• History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
• Serum potassium level <3.5 or >5.0 mmol/L
• Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation
• Subjects with a history of renal transplant
• Subjects with clinically significant hypotension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-3995 High group	MT-3995 High	-
Placebo group	Placebo	-
MT-3995 Low group	MT-3995 Low	-

Primary Outcome Measures

Name	Time	Method
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.	up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.	up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage change from baseline in UACR compared to placebo	up to 8 weeks
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.	up to 8 weeks
Plasma concentrations of MT-3995 and its major metabolite	up to 16 weeks

Trial Locations

Locations (1)

Investigational site; 🇸🇰 Sturovo, Slovakia