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

February 5, 2015 updated by: Mitsubishi Tanabe Pharma Corporation

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

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

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Blagoevgrad, Bulgaria
        • Investigational Site
      • Burgas, Bulgaria
        • Investigational Site
      • Byala, Bulgaria
        • Investigational Site
      • Gulyantsi, Bulgaria
        • Investigational Site
      • Pazardzhik, Bulgaria
        • Investigational Site
      • Plovdiv, Bulgaria
        • Investigational Site
      • Ruse, Bulgaria
        • Investigational Site
      • Sofia, Bulgaria
        • Investigational Site
      • Varna, Bulgaria
        • Investigational Site
      • Baja, Hungary
        • Investigational Site
      • Budapest, Hungary
        • Investigational Site
      • Debrecen, Hungary
        • Investigational Site
      • Eger, Hungary
        • Investigational Site
      • Kistelek, Hungary
        • Investigational Site
      • Komarom, Hungary
        • Investigational Site
      • Pecs, Hungary
        • Investigational Site
      • Szigetvar, Hungary
        • Investigational Site
      • Szikszo, Hungary
        • Investigational Site
      • Zalaegerszeg, Hungary
        • Investigational Site
      • Kaunas, Lithuania
        • Investigational Site
      • Klaipeda, Lithuania
        • Investigational Site
      • Vilnius, Lithuania
        • Investigational Site
      • Bacau, Romania
        • Investigational Site
      • Baia Mare, Romania
        • Investigational Site
      • Braila, Romania
        • Investigational Site
      • Brasov, Romania
        • Investigational Site
      • Bucuresti, Romania
        • Investigational Site
      • Cluj-Napoca, Romania
        • Investigational Site
      • Iasi, Romania
        • Investigational Site
      • Oradea, Romania
        • Investigational Site
      • Ploiesti, Romania
        • Investigational Site
      • Satu Mare, Romania
        • Investigational Site
      • Targu Mures, Romania
        • Investigational Site
      • Timisoara, Romania
        • Investigational Site
      • Banska Bystrica, Slovakia
        • Investigational Site
      • Bardejov, Slovakia
        • Investigational Site
      • Bratislava, Slovakia
        • Investigational Site
      • Lucenec, Slovakia
        • Investigational Site
      • Martin, Slovakia
        • Investigational Site
      • Nitra, Slovakia
        • Investigational Site
      • Sahy, Slovakia
        • Investigational Site
      • Sturovo, Slovakia
        • Investigational Site
      • Zilina, Slovakia
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Placebo for 8 weeks
Experimental: MT-3995 Low group
MT-3995 Low dose for 8 weeks
Experimental: MT-3995 High group
MT-3995 High dose for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Time Frame: up to 8 weeks
up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time Frame: up to 16 weeks
up to 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 27, 2012

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

February 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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