JPRN-jRCT2071210061已完成2 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
Myoishi Masashi0 个研究点目标入组 951 人开始时间: 2021年9月14日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 951
研究概览
简要总结
The study reached its primary exploratory endpoint as >=1 biomarkers were significantly affected by finerenone treatment compared to placebo: Matrilysin, von Willebrand factor, CCN family member 4, and transforming growth factor beta-1 proprotein revealed significant differences between treatment arms after multiplicity correction.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •This study will only include participants who were enrolled in the FIGARO-DKD study (NCT02545049) and had received up to 20 mg finerenone or placebo for >=24 months.
- •-For each participant, pharmacokinetic (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.
排除标准
- •-Participants which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD.
- •-Participants which were not part of the full analysis set (FAS) of FIGARO-DKD.
- •-Participants with known fatal outcome.
- •-Participants with baseline estimated glomerular filtration rate (eGFR) =<25 mL/min/1.73m^2.
- •-Participants with low baseline risk (normal albuminuria and eGFR>=60 mL/min/1.73m^2).
- •-Sponsor request (after discussion with the investigator), for reasons such as a significant protocol deviation.
研究者
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