We conducted a prospective randomized trial in renal transplant recipients of two 6mg/kg rATG dosing protocols, single vs. 4 divided doses. We present 167 patients (single dose n = 83, divided dose n = 84) after a mean follow-up of 26.7 ± 14.3 months. There were no signiﬁcant differences in adverse events related to rATG infusion, patient and graft survival, and acute rejection. Estimated glomerular ﬁltration rate (eGFR) on day 4 was signiﬁcantly higher in the single-dose group than in the divided-dose group (50.0 ± 24.8 vs. 41.2 ± 25.7ml/min/1.73, p = 0.05). Importantly, for the ﬁrst 24 months post-transplantation single-dose recipients showed signiﬁcantly better renal function (p = 0.013), with recipients of kidneys from deceased donors showing the greatest beneﬁt (p = 0.0004). The incidence of chronic allograft nephropathy was lower in the single-dose group (p < 0.05). A composite endpoint (cancer, BK nephropathy, death) strongly trended toward worse outcome in the divided-dose group (p = 0.06). Administration of 6mg/kg rATG as a single 24-hour infusion is safer and is associated with better early and long-term renal function than conventional administration in divided doses.
Available at: http://works.bepress.com/lucile_wrenshall/47/