EUCTR2017-000656-26-SE进行中（未招募）1 期
A randomized, double-blind, multicenter study to assess the efficacy and safety of a 6 monthoral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparisonto placebo on top of standard of care in patients with type II diabetes and a clinical diagnosis ofdiabetic kidney disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 147
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
- •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)
研究者
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