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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)

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ClinicalTrials.gov Identifier: NCT02358096
Recruitment Status : Completed
First Posted : February 6, 2015
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Type 2 Diabetes Drug: ASP8232 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 17, 2015
Actual Primary Completion Date : October 26, 2016
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: ASP8232
ASP8232 administered once daily
Drug: ASP8232
oral capsule

Placebo Comparator: Placebo
Placebo administered once daily
Drug: Placebo
oral capsule




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]
  2. Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment [ Time Frame: Baseline and end of treatment (12 weeks) ]
  3. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358096


  Show 57 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
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Study Director: Executive Director Astellas Pharma Europe B.V.

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02358096     History of Changes
Other Study ID Numbers: 8232-CL-0004
2014-002349-23 ( EudraCT Number )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://www.clinicalstudydatarequest.com/

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Chronic Kidney Disease
Type 2 Diabetes
ASP8232

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Albuminuria
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Proteinuria
Urination Disorders
Urological Manifestations
Signs and Symptoms
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors