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 138 人开始时间: 2017年10月9日最近更新: 2019年12月16日

研究概览

暂无简介。

•1.Patients with T2DM and a clinical diagnosis of DKD (as judged by the investigator) who have finished their up-titration with an ARB or ACEI to their maximum tolerated dose at least 3 months prior to the screening visit, whereby the maximum tolerated dose has to be at least as high as the minimal recommended dose of an ARB or ACEI according to local and/or international guidelines. Patients have to be treated with an ARB or ACEI, but not with both simultaneously, 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)
•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 58

•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 >160mmHg, diastolic blood pressure >100 mmHg (mean of triplicate values at the screening or baseline visit after at least 10 minutes rest in sitting position)

发起方