Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis: A Prospective Exploratory Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete Remission (CR) rate
研究概览
简要总结
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN).
详细描述
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN). The primary objective is to assess the complete remission rate at Week 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •New diagnosis of ANCA-associated vasculitis (Granulomatosis with polyangiitis [GPA] or Microscopic polyangiitis [MPA]) according to the Chapel Hill Consensus Conference definitions.
- •Positive for PR3-ANCA or MPO-ANCA.
- •Active renal involvement indicated by recent renal biopsy (pauci-immune necrotizing and/or crescentic glomerulonephritis) OR active urine sediment characterized by glomerular hematuria and proteinuria.
- •Provided signed informed consent.
排除标准
- •Prior treatment with targeted B-cell therapies (e.g., Rituximab) or standard cyclophosphamide, azathioprine, or mycophenolate mofetil for AAV.
- •Current requirement for dialysis, or history of dialysis.
- •Presence of life-threatening acute vasculitis manifestations other than renal involvement (e.g., diffuse alveolar hemorrhage, respiratory failure, bowel perforation, cerebral vasculitis).
- •History of malignancy within the past 5 years.
- •Coexisting multisystem autoimmune diseases (e.g., systemic lupus erythematosus, anti-GBM disease).
- •Active severe infections, active tuberculosis, or chronic viral infections (HBV with positive HBsAg or HBV-DNA, active HCV, HIV).
- •Pregnant or lactating women.
研究组 & 干预措施
Obinutuzumab beta + Glucocorticoid
Participants receive Obinutuzumab beta intravenous infusion during induction phase, combined with oral glucocorticoids following a prespecified rapid tapering schedule aiming for complete discontinuation by Week 24.
干预措施: Obinutuzumab beta (Drug)
Obinutuzumab beta + Glucocorticoid
Participants receive Obinutuzumab beta intravenous infusion during induction phase, combined with oral glucocorticoids following a prespecified rapid tapering schedule aiming for complete discontinuation by Week 24.
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Complete Remission (CR) rate
时间窗: Month 6 (Week 24)
Proportion of participants achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and complete withdrawal of oral glucocorticoids
次要结局
- Renal Remission (RR) rate(Up to Month 12)
- Change in estimated Glomerular Filtration Rate (eGFR)(Up to Month 12)
- Change in proteinuria(Up to Month 12)
- Incidence of End-Stage Renal Disease (ESRD) or death(Up to Month 12)
- Overall Remission rate(Up to Month 12)
- Proportion of participants achieving peripheral B-cell depletion(Up to Month 12)
- Change in ANCA serological status and titer levels(Up to Month 12)
- Incidence of Treatment-Emergent Adverse Events (TEAEs)(Up to Month 12)
研究者
Zhe Feng
Chief Physician, Professor, Department of Nephrology, Chinese PLA General Hospital
Chinese PLA General Hospital