StudyFinder
PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
Recruiting
PRI-VENT FSGS is a phase III, multicenter, randomized, open label, clinical trial to test the hypothesis that plasmapheresis plus rituximab prior to kidney transplantation can prevent recurrent FSGS in children and adults.
Not specified
Inclusion Criteria:
• 1 to 65 years old
• biopsy proven diagnosis of primary focal segmental glomerulosclerosis (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
• 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
Exclusion Criteria:
• known genetic cause of FSGS
• FSGS secondary to another condition (obesity, viral infection, medications, etc.)
• received rituximab within 1 year prior to transplant
• women who are pregnant, lactating, or refuse use of birth control
• additional medical or mental health diagnosis (study staff will review)
Kidney, Prostate & Urinary
Focal Segmental Glomerulosclerosis
Michelle Rheault - rheau002@umn.edu
Michelle Rheault
STUDY00004388
22836
See this study on ClinicalTrials.gov