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临床试验/NCT03880643
NCT03880643已完成不适用

Efficacy and Safety of Rituximab in Patients With Refractory Primary Membranous Nephropathy

Istanbul University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Complete Remission

研究概览

简要总结

Primary membranous nephropathy (PMN), an autoimmune disease mostly associated with anti-phospholipase-A2-receptor (PLA2R) antibodies, is one of the most common causes of nephrotic syndrome in adults. In 30% to 40% of all cases, patients with PMN undergo spontaneous remission with conservative approaches. Corticosteroids, alkylating agents and calcineurin inhibitors are recommended treatment options in persistent disease activity despite supportive therapies. Nevertheless, patients with refractory disease constitute an important clinical aspect of PMN, and uncontrolled proteinuria may culminate in rapid progression to end-stage renal disease. In recent years, several studies demonstrated the efficacy of rituximab as a treatment option in patients with refractory PMN; however, data regarding daily clinical practice of this agent is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of rituximab in patients with refractory PMN.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having biopsy-proven primary membranous nephropathy.
  • Showing resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.
  • Having a history of rituximab use (375 mg/m2/wk for 2-4 weeks) following resistance aforementioned agents.

排除标准

  • Not providing or withdrawing consent.

结局指标

主要结局

Complete Remission

时间窗: 6 months

Proteinuria \<0.3 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: 6 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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safak Mirioglu

Principal Investigator

Istanbul University

研究点 (1)

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