Background: For patients with end stage renal disease (ESRD) due to primary focal segmental glomerulosclerosis (FSGS), there is a significantly increased risk for disease recurrence and poor graft survival. The aim of this study was to assess the efficacy of rituximab prophylaxis for FSGS recurrence in adult kidney transplant recipients with primary FSGS.

Methods: All patients with primary FSGS who received their first renal transplant between January 2011 and November 2017 at a single center were included (n=55). After September 2015, those at high risk for FSGS recurrence, identified based on age ≤25 at diagnosis of primary FSGS, proteinuria ≥ 5 g/day, and progressions to ESRD ≤ 5-7 years, received a single-dose of rituximab 375 mg/m² BSA (max dose 1000 mg) at the time of transplant. Primary outcome was incidence of recurrent FSGS. Recurrence was diagnosed by proteinuria and transplant kidney biopsy. A historical control included patients with similar criteria who were transplanted between January 2011 and September 2015 and did not receive rituximab. Both groups received the same standard immunosuppression regimen with tacrolimus, mycophenolate, and steroids. Outcomes between the historical control and intervention arm were compared using Chi-square, Fisher's exact test, and T test.

Results: Fifty five patients were included in the analysis. Recipients were 44 years old, 64% were male, and 64% were Caucasian. There were a total of nine graft loses, three were death with functioning graft, and four deaths. All four deaths were in the group prior to the pre-transplant rituximab protocol. Graft loss was similar in both groups, with one (14%) in the rituximab group and eight (17%) in the group transplanted prior to the rituximab protocol. There was also no difference in the urine protein to creatinine ratio (1.3 vs. 3.3, p=0.5) and creatinine at 3 months (1.8mg/dL vs. 2.1mg/dL, p=0.4) between the two groups. FSGS recurred in 6 (12.5%) of the group that did not and in 4 (57%) of the group that did receive pre-transplant rituximab (p = 0.02).

Conclusions: Administration of rituximab prior to transplantation was not associated with improved patient or graft survival. Larger studies need to be performed to identify patients who would benefit from the different treatment modalities.

CITATION INFORMATION: Lu Y., Lyons J., Tischer S., Woodside K., Park J. Efficacy and Safety of a Single-Dose Rituximab for Prevention of Focal Segmental Glomerulosclerosis Recurrence after Kidney Transplant Am J Transplant. 2017;17 (suppl 3).

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