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
- Conditions
- Chronic Kidney DiseaseType 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT02358096
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered once daily ASP8232 ASP8232 ASP8232 administered once daily
- Primary Outcome Measures
Name Time Method Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment Baseline and end of treatment (12 weeks)
- Secondary Outcome Measures
Name Time Method Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment 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 Baseline and end of treatment (12 weeks) Proportion of subjects with either >30% or >40% or >50% reduction in UACR from baseline to end of treatment Baseline and end of treatment (12 weeks)
Trial Locations
- Locations (57)
Site CZ42003
🇨🇿Ceské Budejovice, Czechia
Site CZ42002
🇨🇿Brno, Czechia
Site CZ42001
🇨🇿Prague 4, Czechia
Site CZ42005
🇨🇿Praha 10, Czechia
Site CZ42004
🇨🇿Praha 9, Czechia
Site DK45016
🇩🇰Copenhagen, Denmark
Site DK45007
🇩🇰Holsterbro, Denmark
Site DK45001
🇩🇰Herlev, Denmark
Site DK45006
🇩🇰Viborg, Denmark
Site DE49004
🇩🇪Berlin, Germany
Site HU36010
🇭🇺Budapest, Hungary
Site HU36003
🇭🇺Hatvan, Hungary
Site HU36007
🇭🇺Szigetvar, Hungary
Site PL48008
🇵🇱Lodz, Poland
Site PL48002
🇵🇱Torun, Poland
Site ES34007
🇪🇸Ciudad Real, Spain
Site PL48005
🇵🇱Sopot, Poland
Site PL48025
🇵🇱Warszawa, Poland
Site ES34001
🇪🇸Barcelona, Spain
Site ES34005
🇪🇸Barcelona, Spain
Site ES34002
🇪🇸Barcelona, Spain
Site ES34004
🇪🇸Barcelona, Spain
Site ES34008
🇪🇸Madrid, Spain
Site ES34012
🇪🇸Madrid, Spain
Site ES34003
🇪🇸Palma de Mallorca, Spain
Site ES34006
🇪🇸Lugo, Spain
Site ES34010
🇪🇸Majadahonda, Spain
Site GB44004
🇬🇧Burton-on-Trent, United Kingdom
Site GB44001
🇬🇧Chester, United Kingdom
Site GB44005
🇬🇧London, United Kingdom
Site GB44003
🇬🇧South Yorkshire, United Kingdom
Site DK45002
🇩🇰Hillerød, Denmark
Site PL48026
🇵🇱Lodz, Poland
Site DE49002
🇩🇪Düsseldorf, Germany
Site HU36012
🇭🇺Kaposvar, Hungary
Site DE49008
🇩🇪Elsterwerda, Germany
Site DE49003
🇩🇪Heidelberg, Germany
Site HU36018
🇭🇺Veszprem, Hungary
Site HU36016
🇭🇺Budapest, Hungary
Site HU36002
🇭🇺Balatonfüred, Hungary
Site HU36017
🇭🇺Szekesfehervar, Hungary
Site NL31003
🇳🇱Hoogeveen, Netherlands
Site HU36005
🇭🇺Szikszó, Hungary
Site IT39002
🇮🇹Piacenza, Italy
Site IT39012
🇮🇹Rome, Italy
Site IT39004
🇮🇹Turin, Italy
Site NL31004
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Site IT39007
🇮🇹Bergamo, Italy
Site NL31001
🇳🇱Dordrecht, Netherlands
Site PL48004
🇵🇱Lodz, Poland
Site PL48027
🇵🇱Oświęcim, Poland
Site PL48003
🇵🇱Plock, Poland
Site PL48001
🇵🇱Poznan, Poland
Site PL48022
🇵🇱Radom, Poland
Site PL48006
🇵🇱Rzeszow, Poland
Site IT39005
🇮🇹Pavia, Italy
Site DK45004
🇩🇰Gentofte, Denmark