INTRODUCTION: Desensitization protocols (DES) for HS patients are primarily aimed at living-donor recipients. The efficacy of various DES is not established, especially for DD recipients. These include plasma exchange (PLEX) + low dose IVIG, high dose (HD)-IVIG or HD-IVIG + rituximab (anti-CD20). Here, we explored the efficacy and outcomes of two DES for HS DD candidates. METHODS: From 2/11-6/12, candidates were randomized to IVIG + Placebo v. IVIG + rituximab (IVIG 2gm/kg i.v. weeks 1 & 4; rituximab 1gm or placebo week 2). Total enrollment was planned for 90 patients. End points included rates of transplantation, ABMR, SCr, protocol biopsies at 1 year, patient & graft survival and DSA assessments. RESULTS: Briefly, 15 HS-DDs were randomized and 11(73%) transplanted. However, we discontinued study entry after 4 SAEs were observed (3, ABMR and 2 graft losses). By protocol, the study was unblinded and the attribution of patients to the two protocol arms was noted (IVIG N=5, IVIG + rituximab N=6) (Table 1). No significant differences between treatment groups were seen on PRA or CMXs. All ABMR episodes occurred in the IVIG + Placebo arm and required intense therapy including PLEX + rituximab and eculizumab (anti-C5) (p=0.02). The 2 graft losses were in the placebo group (1ABMR, 1BKAN). Both IVIG and IVIG + rituximab reduced DSA levels to a range permissible for transplantation, but assessment over 6Ms showed significant rebound in the IVIG group which was associated with severe ABMR in 3/5 (60%) patients. 3/6 patients in the IVIG + rituximab arm had protocol biopsies, none with ABMR.

CONCLUSIONS: Based on limited assessment of this placebo controlled trial, both IVIG and IVIG + rituximab are effective in reducing DSA and CMXs to a level allowing transplantation of HS DD recipients. However, IVIG + rituximab was more effective in preventing DSA rebound, ABMR episodes & graft losses. NCT01178216.

Jordan, S.: Grant/Research Support, Genentech, Inc. CSL Behring.

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