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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01889277
First Posted: June 28, 2013
Last Update Posted: January 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
  Purpose
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy

Condition Intervention Phase
Diabetic Nephropathy Drug: MT-3995-Low Drug: MT-3995-High Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 in Subjects With Diabetic Nephropathy

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Frequency and nature of treatment-emergent adverse events and serious adverse events. [ Time Frame: 20 weeks ]
  • Plasma concentrations of MT-3995 and its major metabolite [ Time Frame: 20 weeks ]

Secondary Outcome Measures:
  • Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure [ Time Frame: 20 weeks ]

Enrollment: 51
Study Start Date: July 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MT-3995-Low
MT-3995-Low Dose
Drug: MT-3995-Low
Experimental: MT-3995-High
MT-3995-High Dose
Drug: MT-3995-High
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889277


Locations
Japan
Koukan Hospital
Kawasaki, Kanagawa Pref., Japan
Sponsors and Collaborators
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
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01889277     History of Changes
Other Study ID Numbers: MT-3995-J03
First Submitted: June 26, 2013
First Posted: June 28, 2013
Last Update Posted: January 27, 2015
Last Verified: January 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diabetic Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases