Status:
COMPLETED
PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
United States Department of Defense
Conditions:
Focal Segmental Glomerulosclerosis
Eligibility:
All Genders
1-65 years
Phase:
EARLY_PHASE1
Brief Summary
This is a pilot/feasibility, multicenter, randomized, open label, clinical trial to test that hypothesis that plasmapheresis plus rituximab prior to or at the time of kidney transplantation can preven...
Detailed Description
Recurrent FSGS is a risk factor for graft lost: Recurrence of FSGS can occur rapidly, within minutes of transplantation, and can lead to immediate onset of proteinuria and graft dysfunction. Recurrent...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Age 1-65 years at the time of kidney transplant
- Biopsy proven diagnosis of primary FSGS or minimal change disease
- History of nephrotic syndrome (proteinuria, edema, hypoalbuminemia)
- First kidney transplant or second or third transplant with a history of recurrent FSGS in the first or second kidney transplant.
- The patient (if ≥18 years old) or the child's parent or guardian must be able and willing to give written informed consent and comply with the requirements of the study protocol. Patient assent if \<18 years old will be required per local IRB requirements.
- Negative urine pregnancy test prior to randomization (for females who are post-menarche).
- Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment with rituximab.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1\. Known genetic cause of FSGS 2. Patients with FSGS secondary to another condition (obesity, viral infection, medications, etc.) 3. 4. Received rituximab within 1 year prior to transplant 5. Known hypersensitivity to rituximab, to any of its excipients, or to murine proteins 6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies 7. Known active bacterial, viral (e.g. HIV, hepatitis B, hepatitis C), fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening visit.
- 8\. Participation in another therapeutic trial within 30 days of enrollment or 5 half-lives of the investigational drug (whichever is longer) 9. ANC \< 1.5 x 103 10. Hemoglobin: \< 8.0 gm/dL 11. Platelets: \< 100,000/mm 12. AST or ALT \>2.5 x Upper Limit of Normal at the local institution's laboratory 13. History of drug, alcohol, or chemical abuse within 6 months prior to screening visit.
- 14\. Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential 15. Concomitant malignancies or previous malignancies 16. History of psychiatric disorder that would interfere with normal participation in this protocol 17. History of significant cardiac (including arrhythmias) or pulmonary disease (including obstructive pulmonary disease) 18. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications 19. Inability to comply with study and follow-up procedures
Exclusion
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03763643
Start Date
July 1 2019
End Date
February 7 2025
Last Update
September 10 2025
Active Locations (12)
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1
University of Alabama
Tuscaloosa, Alabama, United States, 35487
2
University of California at Davis
Davis, California, United States, 95616
3
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
4
University of Iowa
Iowa City, Iowa, United States, 52242