Single-bolus high-dose ATG for prophylaxis of rejection in renal transplantation--a prospective, randomized study.

Currently, most centers use antithymocyte globulin (ATG) for induction or treatment of acute rejection. In the literature, postponement of introduction of cyclosporine or delay in acute rejection following ATG induction are well documented [1-4]. In contrast, data are very scant on the reduction of incidence of rejection or improvement of graft survival following ATG prophylaxis [5, 6]. The objective of this study was to compare the efficacy and safety of ATG high-dose single-bolus therapy with that of a standard cyclosporine-based protocol in prophylaxis of acute rejection in renal transplantation in an adult population. Rabbit ATG (Fresenius, Oberursel) was administered intraoperatively (before revascularization) to 19 renal transplant recipients as a single intravenous injection in a dose of 9 mg/kg body weight (high dose, single bolus). Treatment results were compared with those of a control group comprising 19 recipients receiving the same cyclosporin-Neoral-based protocol as the study group. In all patients concomitant medication consisted of steroids and azathioprine. The incidence of acute rejection in the high-dose ATG bolus group was 26%, compared with 58% in controls (P < 0.05). In the ATG treated group no grafts were lost to acute rejection in both high- and low-risk recipients, versus compared with a loss of 37% of rejecting grafts in controls. Though the observed difference in 1-year graft survival between study and control groups (84.2% vs 73.6%) did not reach statistical significance, the same trend was also observed in patients (n = 9 and n = 12 respectively) who, at he time of this report, had completed a 2nd post-transplantation year. The bolus and control groups had a similar incidence of complications and comparable renal function. We conclude that a single-bolus high-ATG protocol is efficient and safe in prophylaxis of renal allograft rejection.

RCT Entities:   Population Interventions Outcomes