Clinical Trial: Rituximab to Prevent Recurrence of Proteinuria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: A total of 60 patients will be enrolled in the study.
Sponsor: George W. Burke

Current Primary Outcome: The percentage of patients who develop nephrotic range proteinuria will be compared between the two treatment arms using an intent-to-treat approach. [ Time Frame: between post transplant day 3 and day 30 ]

Primary outcome.


Original Primary Outcome: The percentage of patients who develop nephrotic range proteinuria will be compared between the two treatment arms using an intent-to-treat approach. [ Time Frame: 4 years ]

Primary outcome.


Current Secondary Outcome: Characterize regulation of SMPDL-3b/ASMase in recurrence FSGS [ Time Frame: from day 1 to 12 months ]

Evaluate if sera of patients with recurrent disease affect podocyte function and survival


Original Secondary Outcome: Determine podocyte SMPDL-3b expression in biopsies of patients with/without recurrence of FSGS. [ Time Frame: 4 years ]

Information By: University of Miami

Dates:
Date Received: July 15, 2010
Date Started: February 2012
Date Completion:
Last Updated: October 19, 2016
Last Verified: October 2016