NCT02205372

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

July 27, 2014

Last Update Submit

September 14, 2015

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

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

    20 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

MT-3995

EXPERIMENTAL
Drug: MT-3995

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MT-3995DRUG
MT-3995
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Touei Hospital

Sapporo, Hokkaido, Japan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

apararenone

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Masaomi Nangaku, Professor

    Division of Nephrology and Endocrinology University of Tokyo School of medicine

    STUDY DIRECTOR

  • Kazuoki Kondou, Adviｓer

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2014

First Posted

July 31, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations

JP(1)