Efficacy and Safety of Rituximab in Adult Patients With Refractory or Relapsed Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Complete Remission
研究概览
简要总结
Various studies have been conducted to identify effective treatment strategies for primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) so far. In the light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of choice and mycophenolic acid derivatives have been seen as a second line agent. However, treatment options in refractory or relapsed cases are still under debate. Recently, rituximab has become an alternative in those patients. Therefore, a study based on registry data was conducted to evaluate the efficacy and safety of rituximab in adult patients suffering from a relapsed or refractory primary FSGS or MCD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having biopsy-proven focal segmental glomerulosclerosis or minimal change disease.
- •Showing resistance to or relapsing after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives.
- •Having a history of rituximab use (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after aforementioned agents.
排除标准
- •Not providing or withdrawing consent.
结局指标
主要结局
Complete Remission
时间窗: 12 months
Proteinuria \<0.5 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine.
Partial Remission
时间窗: 12 months
Proteinuria \<3.5 g/day and a 50% or greater reduction from peak values, confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine.
次要结局
未报告次要终点
研究者
Safak Mirioglu
Principal Investigator
Istanbul University