NCT01164098

Rituximab to Prevent Recurrence of Proteinuria

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: George W. Burke · Academic / Other
• Sex: All
• Age: 7 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• FSGS
• Proteinuria

Interventions

Type	Name	Description
DRUG	Rituximab	Induction therapy

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2010-07-16
• Last updated: 2018-09-20
• Results posted: 2018-09-20

Locations

1 site across 1 country: United States