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CompletedNCT02205372Updated Sep 16, 2015

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

A Phase 1/2 interventional study of MT-3995 and Placebo in Diabetic Nephropathy, sponsored by Mitsubishi Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-16.

Sponsored by Mitsubishi Tanabe Pharma Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetic Nephropathy

Keywords

  • Diabetic Nephropathy
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 31 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Mitsubishi Tanabe Pharma Corporation is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    MT-3995

    Drug: MT-3995

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugMT-3995
  • DrugPlacebo
06

What researchers measure

Primary outcomes

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

    Time frame: 20 weeks

Secondary outcomes

  1. Plasma concentrations of MT-3995

    Time frame: 20 weeks

  2. Plasma concentrations of major metabolite of MT-3995

    Time frame: 20 weeks

  3. Change from baseline in Urine albumin-to-creatinine ratio (UACR)

    Time frame: 20 weeks

  4. Change from baseline in blood pressure

    Time frame: 20 weeks

07

Study locations

1 site
  • Touei Hospital
    Sapporo, Hokkaido, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02205372
Lead sponsor
Mitsubishi Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Jul 31, 2014
Start date
Jul 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Sep 16, 2015

Study contacts

Masaomi Nangaku, Professor
study director · Division of Nephrology and Endocrinology University of Tokyo School of medicine
Kazuoki Kondou, Adviｓer
study director · Mitsubishi Tanabe Pharma Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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