NL-OMON54048尚未招募3 期
A 6-month multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and PK/PD of an age-and body weight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children, 6 months to <18 years of age, with chronic kidney disease and proteinuria - FIONA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Bayer
- 入组人数
- 5
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
- 0 至 17（—）
入选标准
- •- Participants must be 6 months to <18 years
- •- Participants must have a clinical diagnosis of CKD at screening
- •- Participants must have stable kidney function
- •- Treated with an ACEI or ARB at optimized doses
排除标准
- •- Planned urological surgery expected to influence renal function
- •- Children with hemolytic uremic syndrome (HUS) diagnosed <=6 months prior
- •to screening
- •- Patients with nephrotic syndrome receiving albumin infusions within the last 6
- •months prior to screening
- •- Scheduled renal transplant within the next 6 months
- •- Renal allograft in place
研究者
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