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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756716
First Posted: December 27, 2012
Last Update Posted: February 9, 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 pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and Moderately Decreased GFR

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ≥30-<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 ]
  • Frequency and nature of treatment-emergent adverse events and serious adverse events. [ Time Frame: up to 16 weeks ]

Secondary Outcome Measures:
  • Percentage change from baseline in UACR compared to placebo [ Time Frame: up to 8 weeks ]
  • Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group. [ Time Frame: up to 8 weeks ]
  • Plasma concentrations of MT-3995 and its major metabolite [ Time Frame: up to 16 weeks ]

Enrollment: 49
Study Start Date: December 2012
Study Completion Date: September 2014
Primary Completion Date: September 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) ≥30-<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
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): NCT01756716


  Show 50 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01756716     History of Changes
Other Study ID Numbers: MT-3995-E07
First Submitted: December 20, 2012
First Posted: December 27, 2012
Last Update Posted: February 9, 2015
Last Verified: February 2015

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diabetic Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Albuminuria
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms


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