NCT06676579招募中2 期
A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Avacopan and Low Doses Glucocorticoid
Active Comparator
- Methylprednisolone 1g intravenous on day +1
- Prednisone 0.2 mg/kg per day (maximum, 16 mg/day) for 2 months followed by dose tapering by 2 mg per day each month (total duration 6-9 months)
- Avacopan 30 mg oral twice a day (1-0-1) for 12 months
干预措施: Avacopan (Drug)
Avacopan and Low Doses Glucocorticoid
Active Comparator
- Methylprednisolone 1g intravenous on day +1
- Prednisone 0.2 mg/kg per day (maximum, 16 mg/day) for 2 months followed by dose tapering by 2 mg per day each month (total duration 6-9 months)
- Avacopan 30 mg oral twice a day (1-0-1) for 12 months
干预措施: Methylprednisolone (drug) (Drug)
Avacopan and Low Doses Glucocorticoid
Active Comparator
- Methylprednisolone 1g intravenous on day +1
- Prednisone 0.2 mg/kg per day (maximum, 16 mg/day) for 2 months followed by dose tapering by 2 mg per day each month (total duration 6-9 months)
- Avacopan 30 mg oral twice a day (1-0-1) for 12 months
干预措施: Prednisolone (Drug)
High Doses Glucocorticoid
Active Comparator
- Methylprednisolone 1g intravenous on day +1
- Prednisone 0.4 mg/kg per day (maximum, 32 mg/day) for 2 months followed by dose tapering by 4 mg per day each month (total duration 6-9 months)
干预措施: Prednisone (Drug)
High Doses Glucocorticoid
Active Comparator
- Methylprednisolone 1g intravenous on day +1
- Prednisone 0.4 mg/kg per day (maximum, 32 mg/day) for 2 months followed by dose tapering by 4 mg per day each month (total duration 6-9 months)
干预措施: Methylprednisolone (drug) (Drug)
结局指标
主要结局
Change in proteinuria measured by results of protein total, 24-hour urine collection at baseline compared to collection at 12 months.
时间窗: 12 months
A response is based on the average of proteinuria quantified twice over a 2-weeks period at 12 months.
次要结局
- Change in proteinuria >50%(12 months)
- Change in eGFR (using 2021 CKD-EPI Formula)(6 months, 12 months)
- Change in hematuria from Baseline to 12 month visit.(12 months)
研究者
Fernando Fervenza
Principal Investigator
Mayo Clinic
研究点 (2)
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