A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2

Mitsubishi Tanabe Pharma Corporation1 site in 1 country67 target enrollmentNovember 2012

ConditionsDiabetic Nephropathy

InterventionsMT-3995 Low MT-3995 High Placebo

DrugsMT-3995 Low MT-3995 High Placebo

Overview

Phase: Phase 2
Intervention: MT-3995 Low
Conditions: Diabetic Nephropathy
Sponsor: Mitsubishi Tanabe Pharma Corporation
Enrollment: 67
Locations: 1
Primary Endpoint: Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mitsubishi Tanabe Pharma Corporation

Responsible Party

Sponsor

Eligibility Criteria

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) ≥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

Arms & Interventions

MT-3995 Low group

Intervention: MT-3995 Low

MT-3995 High group

Intervention: MT-3995 High

Placebo group

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.

Time Frame: up to 8 weeks

Frequency and nature of treatment-emergent adverse events and serious adverse events.

Time Frame: up to 16 weeks

Secondary Outcomes

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)