Back to resultsRituximab to Prevent Recurrence of Proteinuria
Primary Purpose
FSGS, Proteinuria
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Sponsored by
About this trial
This is an interventional treatment trial for FSGS
Eligibility Criteria
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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Rituximab
No rituximab
Arm Description
Participants will receive Rituximab post within 24 of Kidney Transplant
Participants will not receive Rituximab within 24 hours of Kidney Transplant
Outcomes
Primary Outcome Measures
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.
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
Maximum of the Urine Protein/Creatinine Ratio Observed Between 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)
Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula
Full Information
NCT ID
NCT01164098
First Posted
July 15, 2010
Last Updated
September 18, 2018
Sponsor
George W. Burke
Collaborators
Genentech, Inc., National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01164098
Brief Title
Rituximab to Prevent Recurrence of Proteinuria
Official Title
The Use of Rituximab to Prevent Recurrence of Proteinuria in Patients Receiving Kidney Transplant for FSGS
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Voluntarily terminated by PI due to lack of feasibility.
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
George W. Burke
Collaborators
Genentech, Inc., National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FSGS, Proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
Participants will receive Rituximab post within 24 of Kidney Transplant
Arm Title
No rituximab
Arm Type
No Intervention
Arm Description
Participants will not receive Rituximab within 24 hours of Kidney Transplant
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
Induction therapy
Primary Outcome Measure Information:
Title
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.
Description
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.
Time Frame
between post-transplant day 3 and day 30
Secondary Outcome Measure Information:
Title
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12
Description
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.
Time Frame
Post-Transplant Months 3-12
Title
Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)
Description
Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula
Time Frame
12 months post-transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessia Fornoni, M.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George W. Burke, M.D.
Organizational Affiliation
University of Miami
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Rituximab to Prevent Recurrence of Proteinuria
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