NCT06989359招募中2 期
A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 41
- 主要终点
- Evaluate the safety and tolerability of ADX-038
研究概览
简要总结
This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Mean eGFR greater than or equal to 30 mL/min/1.73m2
- •Clinical evidence of active kidney disease
- •Treated with supportive care including an ACE inhibitor or ARB if applicable
- •Willing to receive required vaccinations
- •Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy
排除标准
- •Hereditary or acquired complement deficiency
- •Kidney transplant or renal replacement therapy
- •History of solid organ transplant
- •Other kidney disease
- •History of recurrent invasive infections
- •Received complement inhibitor treatments
- •Active systemic viral, bacterial, or fungal infection
- •Abnormal liver function
研究组 & 干预措施
ADX-038 Dose Level 1 - IgAN
Experimental
干预措施: ADX-038 Dose Level 1 (Drug)
ADX-038 Dose Level 2 - IgAN
Experimental
干预措施: ADX-038 Dose Level 2 (Drug)
ADX-038 Dose Level 1 - C3G
Experimental
干预措施: ADX-038 Dose Level 1 (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of ADX-038
时间窗: Length of study - 36 months
Incidence and severity of TEAEs
次要结局
未报告次要终点
研究者
研究点 (41)
Loading locations...
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