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: 17.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-002349-23-IT

Lead Sponsor: Astellas Pharma Europe BV (APEB)

Brief Summary: Not available

Detailed Description: Not available

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 = 30 and < 60 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% 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, oral 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 at screening.

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 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 supine systolic blood pressure (SBP) <90 or >160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.