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Terminated Phase 3 Interventional Results available

Rituximab to Prevent Recurrence of Proteinuria

ClinicalTrials.gov ID: NCT01164098

Public ClinicalTrials.gov record NCT01164098. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 20, 2026, 9:00 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01164098
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
George W. Burke
Other
Enrollment
30 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
7 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2012
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016
Last update posted
Sep 19, 2018

2012 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Miami Miami Florida 33136

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01164098, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 19, 2018 · Synced Sep 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01164098 live on ClinicalTrials.gov.

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