- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01756703
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
Conditions
Intervention / Treatment
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
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Blagoevgrad, Bulgaria
- Investigational Site
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Burgas, Bulgaria
- Investigational Site
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Byala, Bulgaria
- Investigational Site
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Gulyantsi, Bulgaria
- Investigational Site
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Pazardzhik, Bulgaria
- Investigational Site
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Plovdiv, Bulgaria
- Investigational Site
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Ruse, Bulgaria
- Investigational Site
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Sofia, Bulgaria
- Investigational Site
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Varna, Bulgaria
- Investigational Site
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Baja, Hungary
- Investigational Site
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Budapest, Hungary
- Investigational Site
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Debrecen, Hungary
- Investigational Site
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Eger, Hungary
- Investigational Site
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Kistelek, Hungary
- Investigational Site
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Komarom, Hungary
- Investigational Site
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Pecs, Hungary
- Investigational Site
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Szigetvar, Hungary
- Investigational Site
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Szikszo, Hungary
- Investigational Site
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Zalaegerszeg, Hungary
- Investigational Site
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Kaunas, Lithuania
- Investigational Site
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Klaipeda, Lithuania
- Investigational Site
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Vilnius, Lithuania
- Investigational Site
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Bacau, Romania
- Investigational Site
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Baia Mare, Romania
- Investigational Site
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Braila, Romania
- Investigational Site
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Brasov, Romania
- Investigational Site
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Bucuresti, Romania
- Investigational Site
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Cluj-Napoca, Romania
- Investigational Site
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Iasi, Romania
- Investigational Site
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Oradea, Romania
- Investigational Site
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Ploiesti, Romania
- Investigational Site
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Satu Mare, Romania
- Investigational Site
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Targu Mures, Romania
- Investigational Site
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Timisoara, Romania
- Investigational Site
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Banska Bystrica, Slovakia
- Investigational Site
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Bardejov, Slovakia
- Investigational Site
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Bratislava, Slovakia
- Investigational Site
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Lucenec, Slovakia
- Investigational Site
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Martin, Slovakia
- Investigational Site
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Nitra, Slovakia
- Investigational Site
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Sahy, Slovakia
- Investigational Site
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Sturovo, Slovakia
- Investigational Site
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Zilina, Slovakia
- 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
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 |
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Placebo Comparator: Placebo group
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Placebo for 8 weeks
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Experimental: MT-3995 Low group
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MT-3995 Low dose for 8 weeks
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Experimental: MT-3995 High group
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MT-3995 High dose for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
Time Frame: up to 8 weeks
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up to 8 weeks
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Frequency and nature of treatment-emergent adverse events and serious adverse events.
Time Frame: up to 16 weeks
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up to 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage change from baseline in UACR compared to placebo
Time Frame: up to 8 weeks
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up to 8 weeks
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Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
Time Frame: up to 8 weeks
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up to 8 weeks
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Plasma concentrations of MT-3995 and its major metabolite
Time Frame: up to 16 weeks
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up to 16 weeks
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MT-3995-E06
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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