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
ALBUM
A Phase 2, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of 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
2 other identifiers
interventional
125
9 countries
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2015
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedStudy Start
First participant enrolled
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2017
CompletedOctober 31, 2024
October 1, 2024
1.6 years
February 3, 2015
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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)
Study Arms (2)
ASP8232
EXPERIMENTALASP8232 administered once daily
Placebo
PLACEBO COMPARATORPlacebo administered once daily
Interventions
Eligibility Criteria
You may qualify if:
- Subject must have an estimated glomerular filtration rate (eGFR) ) \>=25 and \<75 ml/min/1.73m2.
- 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.
You may not qualify if:
- Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (57)
Site CZ42002
Brno, Czechia
Site CZ42003
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
Related Publications (1)
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.
PMID: 30413396DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Executive Director
Astellas Pharma Europe B.V.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2015
First Posted
February 6, 2015
Study Start
March 17, 2015
Primary Completion
October 26, 2016
Study Completion
March 15, 2017
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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/.