NCT01889277

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
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2013

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

First Submitted

Initial submission to the registry

June 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 27, 2015

Status Verified

January 1, 2015

Enrollment Period

1.5 years

First QC Date

June 26, 2013

Last Update Submit

January 26, 2015

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (2)

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

    20 weeks

  • Plasma concentrations of MT-3995 and its major metabolite

    20 weeks

Secondary Outcomes (1)

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

    20 weeks

Study Arms (3)

MT-3995-Low

EXPERIMENTAL

MT-3995-Low Dose

Drug: MT-3995-Low

MT-3995-High

EXPERIMENTAL

MT-3995-High Dose

Drug: MT-3995-High

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MT-3995-LowDRUG
MT-3995-Low
MT-3995-HighDRUG
MT-3995-High
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:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koukan Hospital

Kawasaki, Kanagawa Pref., Japan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

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

June 26, 2013

First Posted

June 28, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 27, 2015

Record last verified: 2015-01

Locations

JP(1)