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Clinical Trial Details

Trial ID: L1005
Source ID: NCT02358096
Associated Drug: Asp8232
Title: 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
Acronym: ALBUM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes
Interventions: DRUG: ASP8232|DRUG: Placebo
Outcome Measures: Primary: Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment, Baseline and end of treatment (12 weeks) | Secondary: Proportion of subjects with either >30% or >40% or >50% reduction in UACR from baseline to end of treatment, Baseline and end of treatment (12 weeks)|Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment, Baseline and end of treatment (12 weeks)|Proportion of subjects with either >30% or >40% or >50% reduction in AER from baseline to end of treatment, Baseline and end of treatment (12 weeks)
Sponsor/Collaborators: Sponsor: Astellas Pharma Europe B.V.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 125
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-03-17
Completion Date: 2017-03-15
Results First Posted:
Last Update Posted: 2024-10-31
Locations: Site CZ42002, Brno, Czechia|Site CZ42003, Ceské Budejovice, 370 01, Czechia|Site CZ42001, Prague 4, 140 21, Czechia|Site CZ42005, Praha 10, 108 00, Czechia|Site CZ42004, Praha 9, 190 00, Czechia|Site DK45016, Copenhagen, 2400, Denmark|Site DK45004, Gentofte, 2820, Denmark|Site DK45001, Herlev, 2730, Denmark|Site DK45002, Hillerød, 3400, Denmark|Site DK45007, Holsterbro, 7500, Denmark|Site DK45006, Viborg, 8800, Denmark|Site DE49004, Berlin, 13125, Germany|Site DE49002, Düsseldorf, 40210, Germany|Site DE49008, Elsterwerda, 04910, Germany|Site DE49003, Heidelberg, 69115, Germany|Site HU36002, Balatonfüred, 8230, Hungary|Site HU36016, Budapest, 1036, Hungary|Site HU36010, Budapest, H-1096, Hungary|Site HU36003, Hatvan, H-3000, Hungary|Site HU36012, Kaposvar, 7400, Hungary|Site HU36017, Szekesfehervar, 8000, Hungary|Site HU36007, Szigetvar, 7900, Hungary|Site HU36005, Szikszó, Hungary|Site HU36018, Veszprem, H- 8200, Hungary|Site IT39007, Bergamo, 24127, Italy|Site IT39005, Pavia, 27100, Italy|Site IT39002, Piacenza, 29100, Italy|Site IT39012, Rome, 00189, Italy|Site IT39004, Turin, 10141, Italy|Site NL31004, Rotterdam, Zuid-Holland, 3045 PM, Netherlands|Site NL31001, Dordrecht, 3318 AT, Netherlands|Site NL31003, Hoogeveen, 7909 AA, Netherlands|Site PL48026, Lodz, 90-302, Poland|Site PL48008, Lodz, 94-048, Poland|Site PL48004, Lodz, 94-225, Poland|Site PL48027, Oświęcim, 32-600, Poland|Site PL48003, Plock, 09-402, Poland|Site PL48001, Poznan, 61655, Poland|Site PL48022, Radom, 26-600, Poland|Site PL48006, Rzeszow, 35-055, Poland|Site PL48005, Sopot, Poland|Site PL48002, Torun, 87-100, Poland|Site PL48025, Warszawa, 00-660, Poland|Site ES34001, Barcelona, 08003, Spain|Site ES34005, Barcelona, 08025, Spain|Site ES34004, Barcelona, 08035, Spain|Site ES34002, Barcelona, 08907, Spain|Site ES34007, Ciudad Real, 13005, Spain|Site ES34006, Lugo, 27880, Spain|Site ES34008, Madrid, 28007, Spain|Site ES34012, Madrid, 28041, Spain|Site ES34010, Majadahonda, 28222, Spain|Site ES34003, Palma de Mallorca, 7120, Spain|Site GB44004, Burton-on-Trent, DE13 0RB, United Kingdom|Site GB44001, Chester, CH2 1UL, United Kingdom|Site GB44005, London, SE1 9RT, United Kingdom|Site GB44003, South Yorkshire, DN2 5LT, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02358096

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