2025-521519-37-00招募中2 期
A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Gd-IgA1 levels through Week 24
研究概览
简要总结
Evaluate the effect of atacicept on Gd-IgA1 in patients with IgAN
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-Up period or Rollover long-term extension study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adult male or female of ≥18 years of age, or as per country specific legally or nationally recognized adult age, who provides written informed consent prior to performing any study assessments
- •Diagnosis of IgAN as demonstrated by renal biopsy with total urine protein excretion ≥0.75 g per 24-hour or UPCR ≥0.75 mg/mg based on a 24-hour urine sample, and eGFR ≥30 ml/min/1.73m2
- •On a stable prescribed SoC regimen according to local practice listed in Section 4 of the protocol
- •Systolic blood pressure ≤160 mmHg and diastolic blood pressure ≤90 mmHg at screening
排除标准
- •IgAN secondary to another condition or other causes of mesangial IgA deposition including IgA vasculitis, evidence of nephrotic syndrome within 6 months of screening, or concomitant chronic renal disease in addition to IgAN
- •Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening)
- •Active viral, bacterial or mycobacterial infections
- •Existing conditions or clinically significant laboratory abnormalities that may interfere with participation in the study
- •Administration of live and live-attenuated vaccinations within 30 days prior to randomization
- •Known hypersensitivity to atacicept or any component of the formulated atacicept
结局指标
主要结局
Gd-IgA1 levels through Week 24
Gd-IgA1 levels through Week 24
次要结局
- Incidence of treatment-emergent adverse events, and changes from baseline in routine laboratory and vital sign parameters
- IgG, IgM, and IgA levels through Week 24
- Serum concentration of atacicept through the end of study
- Anti-drug antibody status through the end of study
- UPCR values through the end of study
研究者
David Wilfret
Scientific
Vera Therapeutics Inc.
研究点 (10)
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