2024-516471-33-00招募中2 期
(22419) A randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Mean UACR ratio to baseline averaged over 16, 20 and 24 weeks of treatment
研究概览
简要总结
Assess the effect of BAY 3401016 on albuminuria in participants with Alport syndrome
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must be 18 to 45 years of age inclusive
- •Participants with AS, either XLAS (male) or ARAS (male or female)
- •eGFR ≥ 45 mL/min/1.73m2
- •UACR ≥ 500mg/g
- •Treatment with ACEi and/or ARB
排除标准
- •Chronic kidney disease is different from AS
- •Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives
- •History or current existence of malignancy
- •Participants with history of severe allergies, multiple drug allergies or non-allergic drug reactions including allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids or urticaria
- •Participants with active skin disorders (e.g. atopic dermatitis, severe acne)
- •Systolic blood pressure above 140 mmHg
- •Diastolic blood pressure above 90 mmHg
结局指标
主要结局
Mean UACR ratio to baseline averaged over 16, 20 and 24 weeks of treatment
Mean UACR ratio to baseline averaged over 16, 20 and 24 weeks of treatment
次要结局
- Number of participants with TEAEs and TESAEs
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (4)
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