Rituximab to Prevent Recurrence of Proteinuria

Part of paid clinical trials in Miami, Florida.

Sponsor
George W. Burke
Study ID
NCT01164098
Phase
PHASE3
Status
Terminated

Conditions

  • FSGS
  • Proteinuria

Eligibility Criteria

Sex
ALL
Age
7 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 29, 2012
Status verified
Sep 2018
Primary completion
Oct 31, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab
    Participants will receive Rituximab post within 24 of Kidney Transplant
  • No Intervention: No rituximab
    Participants will not receive Rituximab within 24 hours of Kidney Transplant

Primary Outcome Measure

Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30. [ Time Frame: between post-transplant day 3 and day 30 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-

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By research site
University of Miami· Miami, FL

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