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Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

MT-3995-Low

MT-3995-High

Placebo

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

History of Type 1 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 within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
Subjects with clinically significant hypotension

Sites / Locations

Koukan Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

MT-3995-Low

MT-3995-High

Placebo

Arm Description

MT-3995-Low Dose

MT-3995-High Dose

Placebo

Outcomes

Primary Outcome Measures

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

Plasma concentrations of MT-3995 and its major metabolite

Secondary Outcome Measures

Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure

Full Information

NCT ID

NCT01889277

First Posted

June 26, 2013

Last Updated

January 26, 2015

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01889277

Brief Title

Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

Keywords

Diabetic Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MT-3995-Low

Arm Type

Experimental

Arm Description

MT-3995-Low Dose

Arm Title

MT-3995-High

Arm Type

Experimental

Arm Description

MT-3995-High Dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

MT-3995-Low

Intervention Type

Drug

Intervention Name(s)

MT-3995-High

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

20 weeks

Title

Plasma concentrations of MT-3995 and its major metabolite

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure

Time Frame

20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: History of Type 1 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 within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation Subjects with clinically significant hypotension

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masaomi Nangaku, Professor

Organizational Affiliation

Division of Nephrology and Endocrinology University of Tokyo School of medicine

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Kazuoki Kondou, Adviser

Organizational Affiliation

Mitsubishi Tanabe Pharma Corporation

Official's Role

Study Director

Facility Information:

Facility Name

Koukan Hospital

City

Kawasaki

State/Province

Kanagawa Pref.

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy

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