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Completed

NCT Number: NCT02358096

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASP8232

Drug

oral capsule

Placebo

Drug

oral capsule

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Astellas Pharma Europe B.V.

Industry

Registry information

Official study 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

Acronym: ALBUM

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 6, 2015
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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