A Study to Evaluate ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) in Reducing Albuminuria in Patients With Type 2 Diabetes and Chronic Kidney Disease
NCT ID: NCT02358096
Last Updated: 2024-10-31
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
125 participants
INTERVENTIONAL
2015-03-17
2017-03-15
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
TRIPLE
Study Groups
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ASP8232
ASP8232 administered once daily
ASP8232
oral capsule
Placebo
Placebo administered once daily
Placebo
oral capsule
Interventions
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ASP8232
oral capsule
Placebo
oral capsule
Eligibility Criteria
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Inclusion Criteria
* Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or parenteral) for at least 1 year prior to screening
* Subject's glycated hemoglobin (HbA1c) level is \< 11.0% (\<97 mmol/mol) at screening.
* Subject is on a stable therapy with an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) for at least 3 months prior to screening.
* Subject who receives anti-hypertensive treatment, non-insulin anti-diabetic agents and/or vitamin D receptor activators at screening needs to be on stable therapy for at least 3 months prior to screening. Subjects on insulin therapy may have the insulin type/dose/schedule adjusted even during the 3 months prior to screening.
* If the subject has been subjected to specific dietary interventions then this has to be stable over the past 3 months prior to screening visit.
* Subject's UACR is ≥ 200 and ≤ 3000 mg/g in a first morning void (FMV) sample at screening AND the geometric mean UACR of all FMV samples at visit 4 and at visit 5 is ≥ 200 and ≤ 3000 mg/g AND the UACR in at least 3 FMV samples at visit 4 and visit 5 is ≥ 200 mg/g.
Exclusion Criteria
* Subject has obstructive uropathy or other causes of renal impairment not related to parenchymal renal disorder and/or disease of the kidney; or subject currently has or has had in the past renal disease secondary to malignancy.
* Subject's renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease.
* Subject has known (auto-) immune disorder and/or received immunosuppression for more than 2 weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study.
* Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization
* Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology.
* Subject has a sitting systolic blood pressure (SBP) \<90 or \>160 mmHg and/or a diastolic blood pressure (DBP) \>90 mmHg at screening.
18 Years
85 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Executive Director
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site CZ42002
Brno, , Czechia
Site CZ42003
České Budějovice, , Czechia
Site CZ42005
Prague, , Czechia
Site CZ42001
Prague, , Czechia
Site CZ42004
Prague, , Czechia
Site DK45016
Copenhagen, , Denmark
Site DK45004
Gentofte Municipality, , Denmark
Site DK45001
Herlev, , Denmark
Site DK45002
Hillerød, , Denmark
Site DK45007
Holsterbro, , Denmark
Site DK45006
Viborg, , Denmark
Site DE49004
Berlin, , Germany
Site DE49002
Düsseldorf, , Germany
Site DE49008
Elsterwerda, , Germany
Site DE49003
Heidelberg, , Germany
Site HU36002
Balatonfüred, , Hungary
Site HU36016
Budapest, , Hungary
Site HU36010
Budapest, , Hungary
Site HU36003
Hatvan, , Hungary
Site HU36012
Kaposvár, , Hungary
Site HU36017
Székesfehérvár, , Hungary
Site HU36007
Szigetvár, , Hungary
Site HU36005
Szikszó, , Hungary
Site HU36018
Veszprém, , Hungary
Site IT39007
Bergamo, , Italy
Site IT39005
Pavia, , Italy
Site IT39002
Piacenza, , Italy
Site IT39012
Rome, , Italy
Site IT39004
Turin, , Italy
Site NL31004
Rotterdam, South Holland, Netherlands
Site NL31001
Dordrecht, , Netherlands
Site NL31003
Hoogeveen, , Netherlands
Site PL48026
Lodz, , Poland
Site PL48008
Lodz, , Poland
Site PL48004
Lodz, , Poland
Site PL48027
Oświęcim, , Poland
Site PL48001
Poznan, , Poland
Site PL48003
Płock, , Poland
Site PL48022
Radom, , Poland
Site PL48006
Rzeszów, , Poland
Site PL48005
Sopot, , Poland
Site PL48002
Torun, , Poland
Site PL48025
Warsaw, , Poland
Site ES34001
Barcelona, , Spain
Site ES34005
Barcelona, , Spain
Site ES34004
Barcelona, , Spain
Site ES34002
Barcelona, , Spain
Site ES34007
Ciudad Real, , Spain
Site ES34006
Lugo, , Spain
Site ES34008
Madrid, , Spain
Site ES34012
Madrid, , Spain
Site ES34010
Majadahonda, , Spain
Site ES34003
Palma de Mallorca, , Spain
Site GB44004
Burton-on-Trent, , United Kingdom
Site GB44001
Chester, , United Kingdom
Site GB44005
London, , United Kingdom
Site GB44003
South Yorkshire, , United Kingdom
Countries
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References
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de Zeeuw D, Renfurm RW, Bakris G, Rossing P, Perkovic V, Hou FF, Nangaku M, Sharma K, Heerspink HJL, Garcia-Hernandez A, Larsson TE. Efficacy of a novel inhibitor of vascular adhesion protein-1 in reducing albuminuria in patients with diabetic kidney disease (ALBUM): a randomised, placebo-controlled, phase 2 trial. Lancet Diabetes Endocrinol. 2018 Dec;6(12):925-933. doi: 10.1016/S2213-8587(18)30289-4. Epub 2018 Nov 6.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2014-002349-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8232-CL-0004
Identifier Type: -
Identifier Source: org_study_id
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