A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria
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
1 other identifier
interventional
67
5 countries
43
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2012
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 20, 2012
CompletedFirst Posted
Study publicly available on registry
December 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 9, 2015
February 1, 2015
1.7 years
December 20, 2012
February 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.
up to 16 weeks
Secondary Outcomes (3)
Percentage change from baseline in UACR compared to placebo
up to 8 weeks
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
up to 8 weeks
Plasma concentrations of MT-3995 and its major metabolite
up to 16 weeks
Study Arms (3)
MT-3995 Low group
EXPERIMENTALMT-3995 High group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Investigational site
Blagoevgrad, Bulgaria
Investigational site
Burgas, Bulgaria
Investigational site
Byala, Bulgaria
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Golenci, Bulgaria
Investigational site
Pazardzhik, Bulgaria
Investigational site
Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Baja, Hungary
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Budapest, Hungary
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Debrecen, Hungary
Investigational site
Eger, Hungary
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Kistelek, Hungary
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Komárom, Hungary
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Pécs, Hungary
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Szigetvár, Hungary
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Szikszó, Hungary
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Zalaegerszeg, Hungary
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Bacau, Romania
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Baia Mare, Romania
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Brasov, Romania
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Brăila, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Iași, Romania
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Oradea, Romania
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Ploieşti, Romania
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Satu Mare, Romania
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Târgu Mureş, Romania
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Timișoara, Romania
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Banská Bystrica, Slovakia
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Bardejov, Slovakia
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Bratislava, Slovakia
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Lučenec, Slovakia
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Martin, Slovakia
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Nitra, Slovakia
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Šahy, Slovakia
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Štúrovo, Slovakia
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Žilina, Slovakia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2012
First Posted
December 27, 2012
Study Start
November 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
February 9, 2015
Record last verified: 2015-02