Status:
TERMINATED
Rituximab to Prevent Recurrence of Proteinuria
Lead Sponsor:
George W. Burke
Collaborating Sponsors:
Genentech, Inc.
National Institutes of Health (NIH)
Conditions:
FSGS
Proteinuria
Eligibility:
All Genders
7-65 years
Phase:
PHASE3
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 impli...
Detailed Description
A total of 60 patients will be enrolled in the study.
Eligibility Criteria
Inclusion
- Inclusion:
- Patient has been fully informed and has signed a dated IRB-approval informed consent form.
- Age 7-65 years.
- Male and Females diagnosed of FSGS by kidney biopsy. Kidney biopsy report is not required once the physician confirms the diagnosis. Transcribed reports from referring physicians are also valid.
- Exclusion:
- Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C viruses, or Hepatitis B virus antigenemia.
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or carcinoma in situ of the cervix that has been treated successfully.
- Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives.
- Patient is pregnant or lactating.
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in opinion of the investigator, may invalidate communication with the investigator.
- Patients with a defined genetic cause of FSGS.
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01164098
Start Date
February 1 2012
End Date
October 1 2016
Last Update
September 20 2018
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136