Maintaining or Stopping Immunosuppressive Therapy in Patients With ANCA Vasculitis and End-stage Renal Disease: a Prospective, Multicenter, Randomized, Open-label, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 91
- 主要终点
- The primary end point will be the time between inclusion and the first severe prejudicial event (measured in days) during 24 months of follow-up.
研究概览
简要总结
This prospective randomized trial aims to evaluate the feasibility, risk and benefit of the discontinuation of immunosuppressive maintenance treatments in AAV (Antineutrophil Cytoplasmic Autoantibodies (ANCA)-associated vasculitis) patients who have reached ESRD (end-stage renal disease). Our hypothesis is that discontinuation of immunosuppressive therapy in AAV patients with ESRD will not expose these patients to an excessive risk of extra-renal AAV relapse, while reducing the rate of complications due to immunosuppression, particularly infections.
Patients with ESRD related to AAV will be randomized into 2 arms:
arm 1: discontinuation (or not initiation) of maintenance treatment (Experimental group) arm 2: maintenance (or initiation) of immunosuppressive treatment (Control group).
The main objective of this study is to demonstrate a 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. The second objectives include the frequency of major and minor relapses, of infectious episodes and leukopenia in both groups and the establishment of a prospective database regarding the outcome of ESRD-AAV patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 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
- •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 receveid 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
- •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.
研究组 & 干预措施
Discontinuation of maintenance treatment
干预措施: Discontinuation (or not initiation) of Immunosuppressive Therapy (Other)
Maintenance of immunosuppressive treatment
干预措施: Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl® (Drug)
结局指标
主要结局
The primary end point will be the time between inclusion and the first severe prejudicial event (measured in days) during 24 months of follow-up.
时间窗: During the 24 months of follow-up
Severe prejudicial event is defined by the occurrence of: severe infection, major AAV relapse, death
次要结局
未报告次要终点