Weaning of Immunosuppression in Nephritis of Lupus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- discontinuation of maintenance immunosuppressive therapy
研究概览
简要总结
The investigators wish to evaluate the discontinuation of maintenance immunosuppressive treatment after 2 years in patients with stable remission after a proliferative lupus nephritis. The patients will be continuing their treatment with hydroxychloroquine, possibly associated with low dose corticosteroids.
详细描述
open multicenter randomized non-inferiority study, comparing 2 types of therapeutic strategies after 2 years of maintenance treatment:
- Group I: Continuation of immunosuppressive therapy with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids.
- Group II: immunosuppressive treatment discontinuation, continuation of hydroxychloroquine, and possibly low-dose corticosteroids (15 mg / day).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18-years-old patient, woman or man,
- •Patient having a lupus according to the criteria of the ACR,
- •Patient having presented a glomérulonéphrite lupique proliférative (class III or IV Has +/-C, +/-list(classify) V) - first push or relapse - proved by renal biopsy,
- •Patient having received for this push a treatment of attack by steroids with strong doses and cyclophosphamide or mycophénolate mofétil,
- •Patient in the course of treatment of interview(maintenance) by azathioprine or mycophénolate mofétil for at least 2 years, and at most for 3 years, with at the time of the inclusion, mycophénolate mofétil? 1 gram / day or azathioprine? 50 in the daytime,
- •Patient in reply renal complete or partial (criteria of the European, secondary consensus 2) since? 12 months,
- •Patient under Plaquenil ® since? 6 months with a hydroxychloroquinémie = 750 µg / L,
- •Patient having accepted of participated in the study and having signed a lit(enlightened) consent.
排除标准
- •Patient presenting a severe chronic renal insufficiency (DFG estimated(esteemed) by MDRD < 30 ml / min / 1.73m ²),
- •Patient having presented an extra-renal push having required an increase of corticoids à> 20 in the daytime during at least 7 days less than 6 months ago,
- •Patient presenting a contraindication to the hydroxychloroquine,
- •Unaffiliated patient in a national social security,
- •Minor patient.
研究组 & 干预措施
immunosuppressive treatment discontinuation,
干预措施: immunosuppressive treatment discontinuation (Other)
Continuation of immunosuppressive therapy
with MMF or AZA, with a background therapy with hydroxychloroquine, and possibly low-dose corticosteroids
干预措施: mycophenolate mofetil or azathioprine (Drug)
结局指标
主要结局
discontinuation of maintenance immunosuppressive therapy
时间窗: 2 years
to demonstrate that discontinuation of maintenance immunosuppressive therapy does not expose patients to a greater risk of relapse of proliferative lupus nephritis compared to the continuation of this treatment
次要结局
- compare 2 therapeutic strategies(2 years)