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临床试验/CTIS2023-506897-11-00
CTIS2023-506897-11-00进行中(未招募)1 期

(21177) A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease - 21177

Bayer AG0 个研究点目标入组 1,584 人开始时间: 2024年3月7日最近更新:
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
1,584

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • A clinical diagnosis of chronic kidney disease and: • Urine albumin/creatinine ratio (UACR) of = 200 but = 3500 mg/g and estimated glomerular filtration rate (eGFR) =25 but <90 mL/min/1.73m^2 at screening, and • Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening., Stable and maximum tolerated labeled dose of an Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker(ARB) for at least 4 weeks prior to screening, K+ = 4.8 mmol/L at screening

排除标准

  • Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c = 6.5% (48 mmol/mol), Autosomal dominant or autosomal recessive polycystic kidney disease, Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) - associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening, Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonist (MRA)s

研究者

发起方
Bayer AG

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