Rituximab to Prevent Recurrence of Proteinuria

Phase 3

Terminated

• Conditions: FSGS; Proteinuria
• Interventions: Drug: Rituximab

• Registration Number: NCT01164098
• Lead Sponsor: George W. Burke

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 Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Study Start: 2012-02
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Disposition First Submitted: 2017-08-16
• Disposition First Submitted QC: 2017-08-18
• Disposition First Posted: 2017-08-22
• Results First Submitted: 2018-08-22
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-18
• Last Update Submitted: 2018-09-18
• Results First Posted: 2018-09-20
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituximab	Rituximab	Participants will receive Rituximab post within 24 of Kidney Transplant

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12	Post-Transplant Months 3-12	Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 will be compared between the two treatment arms using an intent-to-treat approach.
Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)	12 months post-transplant	Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States