Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation Identifier:
First received: December 20, 2012
Last updated: September 24, 2014
Last verified: September 2014

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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2

Resource links provided by NLM:

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group. [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Frequency and nature of treatment-emergent adverse events and serious adverse events. [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage change from baseline in UACR compared to placebo [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group. [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations of MT-3995 and its major metabolite [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MT-3995 Low group Drug: MT-3995 Low
MT-3995 Low dose for 8 weeks
Experimental: MT-3995 High group Drug: MT-3995 High
MT-3995 High dose for 8 weeks
Placebo Comparator: Placebo group Drug: Placebo
Placebo for 8 weeks


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
  • Glycosylated haemoglobin (HbA1c) ≤10.5%
  • An estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m^2
  • Subject with albuminuria

Exclusion Criteria:

  • History of Type I 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 (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation
  • Subjects with a history of renal transplant
  • Subjects with clinically significant hypotension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01756703

  Show 43 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation Identifier: NCT01756703     History of Changes
Other Study ID Numbers: MT-3995-E06
Study First Received: December 20, 2012
Last Updated: September 24, 2014
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health
Hungary: National Institute of Pharmacy
Bulgaria: Bulgarian Drug Agency
Romania: Ministry of Public Health
Slovakia: State Institute for Drug Control

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diabetic Nephropathy

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations processed this record on November 25, 2014