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)

October 29, 2024 updated by: Astellas Pharma Europe B.V.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Site CZ42002
      • Ceské Budejovice, Czechia, 370 01
        • Site CZ42003
      • Prague 4, Czechia, 140 21
        • Site CZ42001
      • Praha 10, Czechia, 108 00
        • Site CZ42005
      • Praha 9, Czechia, 190 00
        • Site CZ42004
  • Denmark
      • Copenhagen, Denmark, 2400
        • Site DK45016
      • Gentofte, Denmark, 2820
        • Site DK45004
      • Herlev, Denmark, 2730
        • Site DK45001
      • Hillerød, Denmark, 3400
        • Site DK45002
      • Holsterbro, Denmark, 7500
        • Site DK45007
      • Viborg, Denmark, 8800
        • Site DK45006
  • Germany
      • Berlin, Germany, 13125
        • Site DE49004
      • Düsseldorf, Germany, 40210
        • Site DE49002
      • Elsterwerda, Germany, 04910
        • Site DE49008
      • Heidelberg, Germany, 69115
        • Site DE49003
  • Hungary
      • Balatonfüred, Hungary, 8230
        • Site HU36002
      • Budapest, Hungary, 1036
        • Site HU36016
      • Budapest, Hungary, H-1096
        • Site HU36010
      • Hatvan, Hungary, H-3000
        • Site HU36003
      • Kaposvar, Hungary, 7400
        • Site HU36012
      • Szekesfehervar, Hungary, 8000
        • Site HU36017
      • Szigetvar, Hungary, 7900
        • Site HU36007
      • Szikszó, Hungary
        • Site HU36005
      • Veszprem, Hungary, H- 8200
        • Site HU36018
  • Italy
      • Bergamo, Italy, 24127
        • Site IT39007
      • Pavia, Italy, 27100
        • Site IT39005
      • Piacenza, Italy, 29100
        • Site IT39002
      • Rome, Italy, 00189
        • Site IT39012
      • Turin, Italy, 10141
        • Site IT39004
  • Netherlands
      • Dordrecht, Netherlands, 3318 AT
        • Site NL31001
      • Hoogeveen, Netherlands, 7909 AA
        • Site NL31003
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3045 PM
        • Site NL31004
  • Poland
      • Lodz, Poland, 90-302
        • Site PL48026
      • Lodz, Poland, 94-048
        • Site PL48008
      • Lodz, Poland, 94-225
        • Site PL48004
      • Oświęcim, Poland, 32-600
        • Site PL48027
      • Plock, Poland, 09-402
        • Site PL48003
      • Poznan, Poland, 61655
        • Site PL48001
      • Radom, Poland, 26-600
        • Site PL48022
      • Rzeszow, Poland, 35-055
        • Site PL48006
      • Sopot, Poland
        • Site PL48005
      • Torun, Poland, 87-100
        • Site PL48002
      • Warszawa, Poland, 00-660
        • Site PL48025
  • Spain
      • Barcelona, Spain, 08035
        • Site ES34004
      • Barcelona, Spain, 08003
        • Site ES34001
      • Barcelona, Spain, 08025
        • Site ES34005
      • Barcelona, Spain, 08907
        • Site ES34002
      • Ciudad Real, Spain, 13005
        • Site ES34007
      • Lugo, Spain, 27880
        • Site ES34006
      • Madrid, Spain, 28007
        • Site ES34008
      • Madrid, Spain, 28041
        • Site ES34012
      • Majadahonda, Spain, 28222
        • Site ES34010
      • Palma de Mallorca, Spain, 7120
        • Site ES34003
  • United Kingdom
      • Burton-on-Trent, United Kingdom, DE13 0RB
        • Site GB44004
      • Chester, United Kingdom, CH2 1UL
        • Site GB44001
      • London, United Kingdom, SE1 9RT
        • Site GB44005
      • South Yorkshire, United Kingdom, DN2 5LT
        • Site GB44003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASP8232
ASP8232 administered once daily
Drug: ASP8232
oral capsule
Placebo Comparator: Placebo
Placebo administered once daily
Drug: Placebo
oral capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Baseline and end of treatment (12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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)
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)
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)
Baseline and end of treatment (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Europe B.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Executive Director, Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8232-CL-0004
  • 2014-002349-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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