- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889277
Safety, Tolerability and Pharmacokinetic Study of MT-3995 in Subjects With Diabetic Nephropathy
January 26, 2015 updated by: Mitsubishi Tanabe Pharma Corporation
A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 in Subjects With Diabetic Nephropathy
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 2
- Phase 1
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
-
-
Kanagawa Pref.
-
Kawasaki, Kanagawa Pref., Japan
- Koukan Hospital
-
-
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:
- Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
- Glycosylated haemoglobin (HbA1c) ≤10.5%
- Subject with albuminuria
Exclusion Criteria:
- History of Type 1 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 within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
- 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
|
|
Experimental: MT-3995-Low
MT-3995-Low Dose
|
|
Experimental: MT-3995-High
MT-3995-High Dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time Frame: 20 weeks
|
20 weeks
|
Plasma concentrations of MT-3995 and its major metabolite
Time Frame: 20 weeks
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure
Time Frame: 20 weeks
|
20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Masaomi Nangaku, Professor, Division of Nephrology and Endocrinology University of Tokyo School of medicine
- Study Director: Kazuoki Kondou, Adviser, Mitsubishi Tanabe Pharma Corporation
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, 2013
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
June 26, 2013
First Submitted That Met QC Criteria
June 26, 2013
First Posted (Estimate)
June 28, 2013
Study Record Updates
Last Update Posted (Estimate)
January 27, 2015
Last Update Submitted That Met QC Criteria
January 26, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-3995-J03
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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