2022-503024-27-00招募中3 期
(22267) A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of finerenone versus placebo, in addition to standard of care, in participants with chronic kidney disease and type 1 diabetes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 105
- 试验地点
- 23
- 主要终点
- Change in UACR from baseline (ratio to baseline) over 6 months
研究概览
简要总结
To demonstrate that finerenone in addition to SoC is superior to placebo in reducing UACR over 6 months in participants with CKD and T1D
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall study
- 盲法
- Double (Subject, Investigator, Carer, Monitor, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥18 years of age (or the legal age of consent according to local legislation) at the time of signing the informed consent.
- •Participants with T1D, i.e. T1D continuously treated with insulin, started within one year from diagnosis.
- •HbA1c at Screening <10% (central assessment). Note: One reassessment is allowed for HbA1c during the Screening period in case the first measurement is missing/unreadable/invalid.
- •K+ ≤ 4.8 mmol/L at Screening (local assessment)
- •"Participants with a clinical diagnosis of CKD and fulfilling both the criteria (central assessment): - eGFR ≥25 and <90 mL/min/1.73 m2 using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula at the Screening visit - UACR ≥200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) "
- •Participants on a stable (preferably without any change in the dosage for at least 4 weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor) or ARB (Angiotensin receptor blocker) treatment.
排除标准
- •Participant with T2D (Type 2 diabetes).
- •Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic BP lower than 90 mmHg at the Screening visit
- •Participants with current or previous (within 8 weeks prior to the Screening visit) treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1 receptor agonist.
- •Previous assignment to study intervention during this study.
结局指标
主要结局
Change in UACR from baseline (ratio to baseline) over 6 months
Change in UACR from baseline (ratio to baseline) over 6 months
次要结局
- Number of participants with TEAEs, TESAEs and Hyperkalaemia (AESI)
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (23)
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