Chronic Kidney DiseasePhase 2ALBUMNCT02358096
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
A Phase 2 study testing ASP8232 in people with Chronic Kidney Disease and Type 2 Diabetes, run by Astellas Pharma Europe B.V. at 57 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes
- What is being tested?
- ASP8232
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 57 sitesin 9 countries
- Study dates
- 17 Mar 2015to 15 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
57 sites in 9 countries.
57 sites in 9 countries
Poland11 sites
Site PL48026
Lodz, 90-302
Site PL48008
Lodz, 94-048
Site PL48004
Lodz, 94-225
Site PL48027
Oświęcim, 32-600
Site PL48003
Płock, 09-402
Site PL48001
Poznan, 61655
Site PL48022
Radom, 26-600
Site PL48006
Rzeszów, 35-055
Site PL48005
Sopot
Site PL48002
Torun, 87-100
Site PL48025
Warsaw, 00-660
Spain10 sites
Site ES34001
Barcelona, 08003
Site ES34005
Barcelona, 08025
Site ES34004
Barcelona, 08035
Site ES34002
Barcelona, 08907
Site ES34007
Ciudad Real, 13005
Site ES34006
Lugo, 27880
Site ES34008
Madrid, 28007
Site ES34012
Madrid, 28041
Site ES34010
Majadahonda, 28222
Site ES34003
Palma de Mallorca, 7120
Hungary9 sites
Site HU36002
Balatonfüred, 8230
Site HU36016
Budapest, 1036
Site HU36010
Budapest, H-1096
Site HU36003
Hatvan, H-3000
Site HU36012
Kaposvár, 7400
Site HU36017
Székesfehérvár, 8000
Site HU36007
Szigetvár, 7900
Site HU36005
Szikszó
Site HU36018
Veszprém, H- 8200
Denmark6 sites
Site DK45016
Copenhagen, 2400
Site DK45004
Gentofte Municipality, 2820
Site DK45001
Herlev, 2730
Site DK45002
Hillerød, 3400
Site DK45007
Holsterbro, 7500
Site DK45006
Viborg, 8800
Czechia5 sites
Site CZ42002
Brno
Site CZ42003
České Budějovice, 370 01
Site CZ42005
Prague, 108 00
Site CZ42001
Prague, 140 21
Site CZ42004
Prague, 190 00
Italy5 sites
Site IT39007
Bergamo, 24127
Site IT39005
Pavia, 27100
Site IT39002
Piacenza, 29100
Site IT39012
Rome, 00189
Site IT39004
Turin, 10141
Germany4 sites
Site DE49004
Berlin, 13125
Site DE49002
Düsseldorf, 40210
Site DE49008
Elsterwerda, 04910
Site DE49003
Heidelberg, 69115
United Kingdom4 sites
Site GB44004
Burton-on-Trent, DE13 0RB
Site GB44001
Chester, CH2 1UL
Site GB44005
London, SE1 9RT
Site GB44003
South Yorkshire, DN2 5LT
Netherlands3 sites
Site NL31001
Dordrecht, 3318 AT
Site NL31003
Hoogeveen, 7909 AA
Site NL31004
Rotterdam, South Holland, 3045 PM
About this study
Official title: 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
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.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Being tested
- ASP8232, Placebo
- Keywords
- Chronic Kidney Disease, Type 2 Diabetes, ASP8232
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP8232Drug
oral capsule
PlaceboDrug
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| ASP8232 | Experimental | ASP8232 administered once daily Receives: Drug: ASP8232 |
| Placebo | Placebo comparator | Placebo administered once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment
Measured: 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
Measured: Baseline and end of treatment (12 weeks)
Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment
Measured: 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
Measured: Baseline and end of treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start17 Mar 2015
- Primary completion26 Oct 2016
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Executive Director, Study director, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358096
- Sponsor's protocol ID
- 8232-CL-0004
- Other IDs
- 2014-002349-23, 2014
- Acronym
- ALBUM
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2015
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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/.
Publications
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.
PubMed 30413396
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02358096
- Acronym / sponsor ID
- ALBUM / 8232-CL-0004
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Keywords
- Chronic Kidney Disease, Type 2 Diabetes, ASP8232
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2015 (actual)
- Primary completion
- 26 Oct 2016 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP8232 | Experimental | Drug: ASP8232ASP8232 administered once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered once daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASP8232oral capsule | Drug | ASP8232 |
| Placebooral capsule | Drug | Placebo |
Primary outcome
Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment
Time frame: Baseline and end of treatment (12 weeks)
3 secondary outcomes
Proportion of subjects with either >30% or >40% or >50% reduction in UACR from baseline to end of treatment
Time frame: Baseline and end of treatment (12 weeks)
Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment
Time frame: 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
Time frame: Baseline and end of treatment (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 30413396de 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.
- Individual participant dataSharing planned: Yes. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Executive Director study director
Astellas Pharma Europe B.V.
57 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASP8232 in people with Chronic Kidney Disease and Type 2 Diabetes, run by Astellas Pharma Europe B.V. at 57 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Poland, Spain, Hungary, Denmark, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment (time frame: Baseline and end of treatment (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.