Abstract
INTRODUCTION: Plasmapheresis (PP) and IVIg treatment of antibody mediated rejection (AMR) produces variable outcomes. We hypothesized that plasma derived C1 esterase inhibitor (C1 INH) would reduce injury during AMR protecting the graft from transplant glomerulopathy (tg). METHODS: This was a multi-center, prospective, randomized trial in 18 kidney transplant recipients with AMR. Subjects were randomized to receive C1 INH or placebo every other day for 2 weeks as add-on therapy to standard of care (SOC = plasmapheresis, IVIg and/or anti-CD20). Endpoints included safety, PK, and effect on renal function and histopathology at day 20 (n=18) and 3-6 months post treatment (n=14). RESULTS: No related serious adverse events were reported. Based on histopathology at 20 days, no differences were observed between treatment groups. Three of seven placebo and none of the C1 INH subjects (0/7) developed new tg at 3-6 months after treatment. Renal function trended towards more sustained improvement in the C1 INH cohort.Figure: No Caption available.The placebo subjects with long-term tg had C1 INH antigenic levels below baseline at end of study drug therapy although no corresponding association was seen on a chromogenic assay for C1 INH activity.Figure: No Caption available.CONCLUSIONS: Human plasma derived C1 INH is well tolerated and may be a useful adjunct to SOC for the prevention of tg after AMR. A larger scale randomized clinical trial is warranted. DISCLOSURE:Montgomery, R.: Grant/Research Support, Alexion, Genzyme, ViroPharma, Other, Astellas, Advisory Board, Gambro, Advisory Board, iPerian, Inc., Advisory Board. Racusen, L.: Grant/Research Support, ViroPharma. Shah, T.: Grant/Research Support, ViroPharma. Woodle, E.: Grant/Research Support, ViroPharma. Sommerer, C.: Grant/Research Support, ViroPharma. Fitts, D.: Employee, ViroPharma. Rockich, K.: Employee, ViroPharma. Uknis, M.: Employee, ViroPharma.
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