A randomized, double-blind, multicenter study to assess the efficacy and safety of a 6 month oral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparison to placebo on top of standard of care in patients with type II diabetes and a clinical diagnosis of diabetic kidney disease

Bayer AG0 个研究点目标入组 107 人开始时间: 2017年10月25日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•1. Patients with T2DM and a clinical diagnosis of DKD (as judged by the investigator) treated with at least the minimal recommended dose of an ARB or an ACEI (according to international or local guidelines) – but not with both simultaneously – for at least 3 months prior to the screening visit without any adjustments to this therapy for at least 4 weeks prior to the screening visit
•2. UACR >50 mg/g and <3000 mg/g in 2 out of 3 consecutive morning void samples at the screening and the baseline visit
•3. eGFR >= 30 mL/min/1.73 m2 and <90 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at the screening visit and the baseline visit
•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 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 27

•1. Non-DKD if it is the main diagnosis contributory to chronic kidney disease (CKD), as judged by the investigator
•2. Known bilateral clinical relevant renal artery stenosis (>75%)
•3. New York Heart Association (NYHA) Class IV
•4. Acute kidney injury or dialysis within the last 3 months before the screening visit
•5. Renal replacement therapy during study conduct
•6. Renal allograft in place or a scheduled kidney transplant during study conduct
•7. Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for heart failure in the last 3 months prior to screening visit
•8. Clinically relevant hepatic dysfunction
•9. Uncontrolled hypertension as evidenced by systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg (mean of triplicate values at the screening or baseline visit after at least 10 minutes rest in sitting position)

发起方