A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 26
- 主要终点
- Safety- Number of participants with treatment related adverse events
研究概览
简要总结
This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.
详细描述
Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Biopsy proven IgAN
- •Urine protein ≥ 0.75g/24 hours at Screening despite optimization with ACE inhibitors or angiotensin receptor blockers (ARB)
- •eGFR ≥ 45 mL/min per 1.73 m2 or eGFR < 45 mL/min per 1.73 m2 and ≥ 30 mL/min per 1.73 m2 with a kidney biopsy within 2 years of Screening showing < 50% tubulointerstitial fibrosis
- •Agree to comply with contraception requirements during and for 90 days after study completion.
排除标准
- •Any secondary IgAN as defined by the investigator
- •Patients who have undergone a kidney transplant
- •Any history of kidney disease other than IgAN
- •Any history of diabetes (Type 1 or Type 2)
- •Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic) at the Screening Visit. Patients must be on a stable dose and regimen of an ACE inhibitor or ARB for at least 90 days
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Arm A
AT-1501 10mg/kg Arm A will receive 10 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions.
干预措施: AT-1501 (Drug)
Arm B
AT-1501 5mg/kg Arm B will receive 5 mg/kg of AT-1501 every 3 weeks for up to 93 weeks for a total of 32 infusions
干预措施: AT-1501 (Drug)
结局指标
主要结局
Safety- Number of participants with treatment related adverse events
时间窗: Through study completion, an average of 100 weeks
Incidence of serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs of special interest (AEoSI)
Efficacy - change in participants UPCR
时间窗: Up to 24 weeks
The change in 24-hour urine protein to creatinine ratio (UPCR) from baseline to 24 weeks
次要结局
- Change in urine protein excretion (mg/mg)(Up to 96 weeks)
- Change in eGFR slope(Baseline- 96 weeks)
- Development of Anti drug Antibodies (ADAs)(Up to 96 weeks)