Rituximab to Prevent Recurrence of Proteinuria
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Transplant |
Drug: Rituximab |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS |
- The percentage of patients who develop nephrotic range proteinuria will be compared between the two treatment arms using an intent-to-treat approach. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Primary outcome.
- Determine podocyte SMPDL-3b expression in biopsies of patients with/without recurrence of FSGS. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2016 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Rituximab |
Drug: Rituximab
Induction therapy
Other Name: Rituxan
|
| No Intervention: No rituximab |
Detailed Description:
A total of 60 patients will be enrolled in the study.
Eligibility| Ages Eligible for Study: | 1 Year to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and Females diagnosed with focal segmental glomerulosclerosis (FSGS).
Exclusion Criteria:
- 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 gastrointestinal 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, lymphoproliferative disorders or any malignant disorders.
Contacts and Locations| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: George W. Burke, M.D. 305-355-5315 gburke@med.miami.edu | |
| Contact: Lois Hanson, R.N. 305-355-5315 lhanson2@med.miami.edu | |
| Principal Investigator: Alessia Fornoni, M.D. | |
| Sub-Investigator: George W. Burke, M.D. | |
| Principal Investigator: | Alessia Fornoni, M.D. | University of Miami |
| Study Director: | George W. Burke, M.D. | University of Miami |
More Information
No publications provided
| Responsible Party: | Clinical Research Initiation Services, Alessia Fornoni, MD., University of Miami |
| ClinicalTrials.gov Identifier: | NCT01164098 History of Changes |
| Other Study ID Numbers: | 20100498 |
| Study First Received: | July 15, 2010 |
| Last Updated: | March 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Proteinuria Recurrence Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Disease Attributes Pathologic Processes |
Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013