Diabetic nephropathy MedDRA version: 18.1 Level: PT Classification code 10061835 Term: Diabetic nephropathy System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Sponsors
Astellas Pharma Europe BV (APEB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject who is = 18 and = 85 years of age. 2. Subject must have a eGFR (based on the CKD-EPI equation) at screening of = 25 and =65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1. Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation). 2. Subject has significant 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. 3. Subject’s renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease 4. Subject has known (auto-) immune disorder and/or received immunosuppression for more than two weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study 5. Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization 6. Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology. 7. Subject has a sitting systolic blood pressure (SBP) 160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1. To evaluate the efficacy of ASP8232 in reducing the 24h urinary albumin excretion rate (AER) in patients with T2DM and CKD at 12 weeks compared to placebo 2. To evaluate the safety and tolerability of ASP8232 in patients with T2DM and CKD 3. To evaluate the pharmacokinetics (PK) of ASP8232 in patients with T2DM and CKD 4. To evaluate pharmacodynamics (PD) of ASP8232 by assessing vascular adhesion protein-1 (VAP-1) plasma concentration and inhibition of VAP-1 activity and total antioxidant status (TAS) in serum ;Primary end point(s): Mean change of log transformed UACR from baseline to end of treatment.;Timepoint(s) of evaluation of this end point: As per schedule of assessments described in the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects with >30%/40%/50% reduction in UACR from baseline to end of treatment • Mean change of log transformed AER from baseline to end of treatment • The proportion of subjects with >30%/40%/50% reduction in AER from baseline to end of treatment ;Timepoint(s) of evaluation of this end point: As per schedule of assessments described in the protocol. | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom
Contacts
Public ContactService Desk - Global Clinical Dev.
Astellas Pharma Europe BV
Outcome results
None listed