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

September 14, 2015 updated by: Mitsubishi Tanabe Pharma Corporation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Touei Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: MT-3995
Drug: MT-3995

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Director: Masaomi Nangaku, Professor, Division of Nephrology and Endocrinology University of Tokyo School of medicine
  • Study Director: Kazuoki Kondou, Adviser, Mitsubishi Tanabe Pharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 27, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-3995-J04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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