- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517320
Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
March 1, 2017 updated by: Mitsubishi Tanabe Pharma Corporation
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
293
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
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Hokkaido, Japan
- Investigational Site
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-
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
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 diabetes mellitus
- Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5%
- estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2
- The median UACR of the first morning void urine samples is ≥50 mg/g Cr and <300 mg/g Cr
- Stable blood pressure(diastolic blood pressure (DBP) <100 mmHg and stable systolic blood pressure (SBP) <160 mmHg)
Exclusion Criteria:
- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
- A diagnosis of non-diabetic renal disease.
A following serum potassium level.
- eGFR of 30-59mL/min/1.73m2; serum potassium level of <3.5 or >4.7 mmol/L,
- eGFR of ≥60mL/min/1.73m2: serum potassium level of <3.5 or >5.0 mmol/L
- symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)<50mmHg and systolic blood pressure(SBP)<110mmHg)
- QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes
- New York Heart Association (NYHA) Class III or IV heart failure
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Experimental: MT-3995 Low
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Experimental: MT-3995 Middle
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Experimental: MT-3995 High
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change form baseline in UACR
Time Frame: Week 24
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Week 24
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in UACR classification
Time Frame: From baseline to 24 weeks
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From baseline to 24 weeks
|
Change in renal function
Time Frame: From baseline to 24 weeks
|
From baseline to 24 weeks
|
Change in serum potassium
Time Frame: From baseline to 24 weeks
|
From baseline to 24 weeks
|
Adverse events
Time Frame: From baseline to 24 weeks
|
From baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
July 1, 2015
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
August 4, 2015
First Submitted That Met QC Criteria
August 6, 2015
First Posted (Estimate)
August 7, 2015
Study Record Updates
Last Update Posted (Actual)
March 3, 2017
Last Update Submitted That Met QC Criteria
March 1, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-3995-J05
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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