A Phase 2, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of 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. - ALBUM

Astellas Pharma Europe BV (APEB)0 个研究点目标入组 110 人开始时间: 2014年10月15日最近更新: 2017年4月18日

适应症

试验速览

暂无简介。

•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. 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.
•8. 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

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

发起方

Astellas Pharma Europe BV (APEB)