A study to evaluate efficacy and safety of ASP8232 as add-on therapy to the standard of care in patients with Type 2 Diabetes and Chronic Kidney Disease.

Phase 1

• Conditions: Diabetic nephropathy; MedDRA version: 19.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2014-002349-23-PL
• Lead Sponsor: Astellas Pharma Europe BV (APEB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-19
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

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 < 75 mL/min/1.73m2.
3. Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or insulin) for at least one year prior to screening.
4. Subject’s HbA1c level is < 11.0% (< 97 mmol/mol) at screening.
5. Subject is on a stable therapy with an ACE inhibitor or ARB for at least three months prior to screening.
6. 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 three months prior to screening.
7. Subject’s UACR is = 200 and = 3000 mg/g in a 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1. Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation).
2. Subject has obstructive significant 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) <90 or >160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. To evaluate the safety and tolerability of ASP8232 in patients with T2DM and CKD <br>3. To evaluate the pharmacokinetics (PK) of ASP8232 in patients with T2DM and CKD<br>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<br>;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 Outcome Measures

Name	Time	Method
Secondary end point(s): • The proportion of subjects with >30%/40%/50% reduction in UACR from baseline to end of treatment<br>• Mean change of log transformed AER from baseline to end of treatment<br>• The proportion of subjects with >30%/40%/50% reduction in AER from baseline to end of treatment <br>;Timepoint(s) of evaluation of this end point: As per schedule of assessments described in the protocol.