Background: The treatment of acute humoral rejection (AHR) is currently based on the combination of plasmepheresis (PE), intravenous immune globulin (IVIg) and corticosteroids (CS). Patients and methods: In this phase 3, multicenter, double-blind, placebo-controlled trial, we randomly assigned patients with biopsy-proven AHR, in a 1:1 ratio to receive rituximab (R) (375 mg/m²) or placebo (P). All patients received PE, IVIg, CS, tacrolimus and MMF. From the 12th day all patients could receive 1 or 2 supplementary administration of R or P. Pprimary endpoint was a composite criterion (graft loss or absence of improvement of renal function at day 12). Secondary outcomes included patient and graft survival, renal function, proteinuria, histology, DSA, supplementary administration of R, total number of IVIg and PE. Results. Among the 38 patients included, with a median of AHR appearance of 35.5 days, the primary end point in the R group was 52.6% (10/19) versus 57.9% (11/19), (p=0.744) with no death. Only one graft loss in each group. Supplementary administrations of rituximab were similar in the R and the P groups (31.6% vs 42.1%, p=0.501). The total number of IVIg and PE was not different in the R and P groups (median:7 [6; 9] vs 7 [6 ;10], p=0.76 and 9 [7 ;13] vs 7 [6; 16], p:0.92). There was no difference in serum creatinine (¯o;mol/l) between the 2 groups: at inclusion, 1, 6, and 12 months: 204 [167 ; 324] vs 197 [139 ; 489], 141 [124 ; 190] vs159 [118 ; 201], 144 [123 ; 179] vs 147 [124 ; 201], 158 [129 ; 217] vs 157 [107 ; 224], respectively. Median proteinuria (g/24h) at 12 months was 0.38 [0.21 ; 0.89] in the P group and 0.30 [0.19 ; 2.74] in the R group. The glomerulitis score (mean± SD) in the P and R groups at inclusion, 1 and 6 months were 1.80±0.68 vs 1.89±0.66, 0.47±0.74 vs 0.59±0.71 and 1.08±1.08 vs 0.40±0.91. Changes in DSA will be presented subsequently. Conclusion R was not superior to P in patients receiving PE, IVIG and CS.

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