EUCTR2021-003053-37-ES
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
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Type II Diabetes Mellitus and Diabetic Kidney Disease
- 发起方
- Bayer AG
- 入组人数
- 600
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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\)
结局指标
主要结局
未指定
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