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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002349-23 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) at 12 weeks compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP8232 | Experimental | ASP8232 administered once daily |
|
| Placebo | Placebo Comparator | Placebo administered once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8232 | Drug | oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment | Baseline and end of treatment (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Executive Director | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CZ42002 | Brno | Czechia | ||||
| Site CZ42003 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30413396 | Derived | 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. |
| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website | View source |
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Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
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| Drug |
oral capsule |
|
| 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) |
| České Budějovice |
| 370 01 |
| Czechia |
| Site CZ42005 | Prague | 108 00 | Czechia |
| Site CZ42001 | Prague | 140 21 | Czechia |
| Site CZ42004 | Prague | 190 00 | Czechia |
| Site DK45016 | Copenhagen | 2400 | Denmark |
| Site DK45004 | Gentofte Municipality | 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 | Kaposvár | 7400 | Hungary |
| Site HU36017 | Székesfehérvár | 8000 | Hungary |
| Site HU36007 | Szigetvár | 7900 | Hungary |
| Site HU36005 | Szikszó | Hungary |
| Site HU36018 | Veszprém | 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 | South 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 PL48001 | Poznan | 61655 | Poland |
| Site PL48003 | Płock | 09-402 | Poland |
| Site PL48022 | Radom | 26-600 | Poland |
| Site PL48006 | Rzeszów | 35-055 | Poland |
| Site PL48005 | Sopot | Poland |
| Site PL48002 | Torun | 87-100 | Poland |
| Site PL48025 | Warsaw | 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 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000633847 | ASP8232 |
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