A Study to Evaluate ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme Inhibitor (ACEi) o… (NCT02358096) | Clinical Trial Compass
CompletedPhase 2
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
Czechia125 participantsStarted 2015-03-17
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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…
What they're measuring
1
Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment
Timeframe: Baseline and end of treatment (12 weeks)