EUCTR2021-003053-37-BG进行中（未招募）1 期
A non-blinded retrospective biomarker add-on study to FIGARO-DKD for Bioprofiling the pharMacodynamic response to finerenone in FIGARO-DKD subjects (FIGARO-BM) - FIGARO-BM
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
- 600
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
- •Signed informed consent to participate in FIGARO-BM
- •Randomized in the FIGARO-DKD trial
- •For each participant, PK plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Subjects which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD
- •Subjects which were not part of the full analysis set (FAS) of FIGARO-DKD.
- •Subjects with known fatal outcome
- •Subjects with baseline eGFR =25 mL/min/1.73m2
- •Subjects with low baseline risk (normal albuminuria and eGFR=60 mL/min/1.73m2)
研究者
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