A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR
NCT ID: NCT01756716
Last Updated: 2015-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2012-12-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MT-3995 Low group
MT-3995 Low
MT-3995 Low dose for 8 weeks
MT-3995 High group
MT-3995 High
MT-3995 High dose for 8 weeks
Placebo group
Placebo
Placebo for 8 weeks
Interventions
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MT-3995 Low
MT-3995 Low dose for 8 weeks
MT-3995 High
MT-3995 High dose for 8 weeks
Placebo
Placebo for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* Glycosylated haemoglobin (HbA1c) ≤10.5%
* An estimated glomerular filtration rate (eGFR) ≥30-\<60 mL/min/1.73m\^2
* Subject with albuminuria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Locations
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Investigational site
Blagoevgrad, , Bulgaria
Investigational site
Pazardzhik, , Bulgaria
Investigational site
Pleven, , Bulgaria
Investigational site
Plovdiv, , Bulgaria
Investigational site
Rousse, , Bulgaria
Investigational site
Sofia, , Bulgaria
Investigational site
Varna, , Bulgaria
Investigational site
České Budějovice, , Czechia
Investigational site
Český Krumlov, , Czechia
Investigational site
Karlovy Vary, , Czechia
Investigational site
Ostrava, , Czechia
Investigational site
Ostrava-Vitkovice, , Czechia
Investigational site
Prague, , Czechia
Investigational site
Slaný, , Czechia
Investigational site
Znojmo, , Czechia
Investigational site
Baja, , Hungary
Investigational site
Budapest, , Hungary
Investigational site
Debrecen, , Hungary
Investigational site
Eger, , Hungary
Investigational site
Kistelek, , Hungary
Investigational site
Komárom, , Hungary
Investigational site
Pécs, , Hungary
Investigational site
Szigetvár, , Hungary
Investigational site
Szikszó, , Hungary
Investigational site
Zalaegerszeg, , Hungary
Investigational site
Krakow, , Poland
Investigational site
Ruda Śląska, , Poland
Investigational site
Rzeszów, , Poland
Investigational site
Świętochłowice, , Poland
Investigational site
Bacau, , Romania
Investigational site
Brăila, , Romania
Investigational site
Bucharest, , Romania
Investigational site
Buzău, , Romania
Investigational site
Cluj-Napoca, , Romania
Investigational site
Deva, , Romania
Investigational site
Iași, , Romania
Investigational site
Oradea, , Romania
Investigational site
Ploiesti, Judet Prahova, , Romania
Investigational site
Satu Mare, , Romania
Investigational site
Târgu Mureş, , Romania
Investigational site
Timișoara, , Romania
Investigational site
Bardejov, , Slovakia
Investigational site
Bratislava, , Slovakia
Investigational site
Levice, , Slovakia
Investigational site
Lučenec, , Slovakia
Investigational site
Martin, , Slovakia
Investigational site
Nitra, , Slovakia
Investigational site
Prešov, , Slovakia
Investigational site
Šahy, , Slovakia
Investigational site
Štúrovo, , Slovakia
Countries
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Other Identifiers
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MT-3995-E07
Identifier Type: -
Identifier Source: org_study_id
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