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临床试验/NCT01164098
NCT01164098终止3 期

The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS

George W. Burke1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
30
试验地点
1
主要终点
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.

研究概览

简要总结

The investigators propose to study novel targets of rituximab in podocytes, with a particular focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong clinical implications, since it may extend the approved indications for rituximab treatment to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new insights into the role of sphyngomyelin related enzymes in podocyte function in health and disease, thus allowing the identification of novel targets for antiproteinuric drug development. Finally, the proposed study offers the opportunity to identify a correlation between the patient's specific clinical outcome and the experimental results obtained after exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may lead to the development of an assay for the pre-transplant identification of patients at high-risk for recurrent disease and, among them, may allow the identification of those patients that will respond to rituximab.

详细描述

A total of 60 patients will be enrolled in the study.

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
7 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Rituximab

Active Comparator

Participants will receive Rituximab post within 24 of Kidney Transplant

干预措施: Rituximab (Drug)

结局指标

主要结局

Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.

时间窗: between post-transplant day 3 and day 30

Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach.

次要结局

  • Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12(Post-Transplant Months 3-12)
  • Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)(12 months post-transplant)

研究者

发起方
George W. Burke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

George W. Burke

Professor of Surgery

University of Miami

研究点 (1)

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