2024-512470-10-00招募中4 期
Maintaining or Stopping immunosuppressive Therapy in patients with ANCA vasculitis and End-stage Renal disease: a prospective, multicenter, randomized, open-label, clinical trial
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 56
- 主要终点
- The primary end point will be the time between randomization and the first severe prejudicial event (severe infection, major AAV relapse, death) during 24 months of follow-up.
研究概览
简要总结
The study's main objective is to demonstrate the superiority of immunosuppression discontinuation in ESRD-AAV patients compared to standard maintenance immunosuppressive therapy in terms of severe prejudicial event-free survival at 24 months.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 90 years
- •Patients affected by a GPA or MPA AAV with a renal injury
- •Patients with initial manifestation or relapse of AAV
- •Patients with ESRD, defined by a glomerular filtration rate estimated using the MDRD formula ≤15 mL/min or requirement for dialysis for more than 60 days
- •Patients with ESRD on native kidney
- •Patients who gave written informed consent for participation in the study
- •Patients with affiliation to the French social security system
排除标准
- •Patients who experienced severe extra-renal disease due to AAV (intra-alveolar haemorrhage with blood oxygen saturation ≤ 85% on room air or ventilated, or central nervous system disease) in the last 12 months prior to inclusion
- •Inability to understand and sign the informed consent
- •Pregnant women
- •Women of child-bearing age without effective method of contraception
- •Age < 18 years or > 90 years
- •Patients under guardianship or trusteeship
- •Patients with AAV-associated renal involvement (with active inflammatory lesions in kidney biopsy) diagnosed less than three months and receiving induction treatment with Cyclophosphamide or Rituximab or diagnosed less than 45 days for patients who have received only treatment based on steroid infusion without Cyclophosphamide or Rituximab
- •Patients who received maintenance immunosuppressive treatment for more than 6 months during the last 12 months
- •Patient with a diagnosis of vasculitis other than GPA or MPA
- •Patients with another immunologic systemic disease (Lupus, sarcoidosis…)
- •Patients with active HCV, HBV or HIV infection
- •Patients with a history of serious viral infection (CMV, HHV8, etc.) in the 2 months prior to the inclusion, or severe uncontrolled chronic infection (tuberculosis, etc.)
- •Patients with uncontrolled cancer or hemopathy
- •Kidney transplant patient
结局指标
主要结局
The primary end point will be the time between randomization and the first severe prejudicial event (severe infection, major AAV relapse, death) during 24 months of follow-up.
The primary end point will be the time between randomization and the first severe prejudicial event (severe infection, major AAV relapse, death) during 24 months of follow-up.
次要结局
未报告次要终点
研究者
Chloé MOREAU
Scientific
Centre Hospitalier Departemental Vendee
研究点 (56)
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