Rituximab to Prevent Recurrence of Proteinuria
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Endocrine, Nephrology |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 7 - 65 |
| Updated: | 9/22/2018 |
| Start Date: | February 2012 |
| End Date: | October 2016 |
The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS
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.
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.
A total of 60 patients will be enrolled in the study.
Inclusion:
1. Patient has been fully informed and has signed a dated IRB-approval informed consent
form.
2. Age 7-65 years.
3. 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:
1. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C
viruses, or Hepatitis B virus antigenemia.
2. 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.
3. 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.
4. Patient is pregnant or lactating.
5. Patient has any form of substance abuse, psychiatric disorder or a condition that, in
opinion of the investigator, may invalidate communication with the investigator.
6. Patients with a defined genetic cause of FSGS.
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University of Miami A private research university with more than 15,000 students from around the...
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