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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MT-3995 Low
MT-3995 High
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MT-3995 Low group

MT-3995 High group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Frequency and nature of treatment-emergent adverse events and serious adverse events.

Secondary Outcome Measures

Percentage change from baseline in UACR compared to placebo
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
Plasma concentrations of MT-3995 and its major metabolite

Full Information

First Posted
December 20, 2012
Last Updated
February 5, 2015
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01756703
Brief Title
A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Diabetic Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-3995 Low group
Arm Type
Experimental
Arm Title
MT-3995 High group
Arm Type
Experimental
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MT-3995 Low
Intervention Description
MT-3995 Low dose for 8 weeks
Intervention Type
Drug
Intervention Name(s)
MT-3995 High
Intervention Description
MT-3995 High dose for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 8 weeks
Primary Outcome Measure Information:
Title
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Time Frame
up to 8 weeks
Title
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Percentage change from baseline in UACR compared to placebo
Time Frame
up to 8 weeks
Title
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
Time Frame
up to 8 weeks
Title
Plasma concentrations of MT-3995 and its major metabolite
Time Frame
up to 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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) ≥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
Facility Information:
Facility Name
Investigational site
City
Blagoevgrad
Country
Bulgaria
Facility Name
Investigational site
City
Burgas
Country
Bulgaria
Facility Name
Investigational site
City
Byala
Country
Bulgaria
Facility Name
Investigational site
City
Gulyantsi
Country
Bulgaria
Facility Name
Investigational site
City
Pazardzhik
Country
Bulgaria
Facility Name
Investigational site
City
Plovdiv
Country
Bulgaria
Facility Name
Investigational site
City
Ruse
Country
Bulgaria
Facility Name
Investigational site
City
Sofia
Country
Bulgaria
Facility Name
Investigational site
City
Varna
Country
Bulgaria
Facility Name
Investigational site
City
Baja
Country
Hungary
Facility Name
Investigational site
City
Budapest
Country
Hungary
Facility Name
Investigational site
City
Debrecen
Country
Hungary
Facility Name
Investigational site
City
Eger
Country
Hungary
Facility Name
Investigational site
City
Kistelek
Country
Hungary
Facility Name
Investigational site
City
Komarom
Country
Hungary
Facility Name
Investigational site
City
Pecs
Country
Hungary
Facility Name
Investigational site
City
Szigetvar
Country
Hungary
Facility Name
Investigational site
City
Szikszo
Country
Hungary
Facility Name
Investigational site
City
Zalaegerszeg
Country
Hungary
Facility Name
Investigational site
City
Kaunas
Country
Lithuania
Facility Name
Investigational site
City
Klaipeda
Country
Lithuania
Facility Name
Investigational site
City
Vilnius
Country
Lithuania
Facility Name
Investigational site
City
Bacau
Country
Romania
Facility Name
Investigational site
City
Baia Mare
Country
Romania
Facility Name
Investigational site
City
Braila
Country
Romania
Facility Name
Investigational site
City
Brasov
Country
Romania
Facility Name
Investigational site
City
Bucuresti
Country
Romania
Facility Name
Investigational site
City
Cluj-Napoca
Country
Romania
Facility Name
Investigational site
City
Iasi
Country
Romania
Facility Name
Investigational site
City
Oradea
Country
Romania
Facility Name
Investigational site
City
Ploiesti
Country
Romania
Facility Name
Investigational site
City
Satu Mare
Country
Romania
Facility Name
Investigational site
City
Targu Mures
Country
Romania
Facility Name
Investigational site
City
Timisoara
Country
Romania
Facility Name
Investigational site
City
Banska Bystrica
Country
Slovakia
Facility Name
Investigational site
City
Bardejov
Country
Slovakia
Facility Name
Investigational site
City
Bratislava
Country
Slovakia
Facility Name
Investigational site
City
Lucenec
Country
Slovakia
Facility Name
Investigational site
City
Martin
Country
Slovakia
Facility Name
Investigational site
City
Nitra
Country
Slovakia
Facility Name
Investigational site
City
Sahy
Country
Slovakia
Facility Name
Investigational site
City
Sturovo
Country
Slovakia
Facility Name
Investigational site
City
Zilina
Country
Slovakia

12. IPD Sharing Statement

Learn more about this trial

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

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