Safety and efficacy of high dose ATG bolus administration on rewascularization in kidney graft patients--long term results.

BACKGROUND: Various preparations of ALG/ATG have been used in clinical transplantation for more than 30 years. In recent years the number of high immunological risk patients has increased and biological agents are being used as induction therapy. The aim of this prospective, randomized study was to asses the safety and efficacy of a single high dose of antithymocyte globulin (9 mg/kg ATG Fresenius S) in cadaveric renal transplantation. The maintenance immunosuppressive regimen consisted of steroids, mycophenolate mofetil (converted after the fourth month to azathioprine), and cyclosporine. MATERIAL/
METHODS: Between November 1997 and April 1999, 79 recipients were included into the study. Patients were randomized to ATG (n=40) or the standard treatment group (n=39) with a follow up period of 5 years.
RESULTS: The incidence of acute rejection was lower in the ATG group--9 patients (22.5%) compared to 14 in the control group (35.9%) (p=NS). The total number of all acute rejections episodes in the ATG group was 11 and 23 in the control group. Steroid resistant rejections occurred in 4 (10%) and 8 (20.5%) patients respectively. The number of infectious complications was similar in both groups (65% - ATG, 67.5% - control, p=NS). Graft survival was 70% for the ATG and 69.23% for the control group. Death censored graft survival was 85% in the ATG and 74.43% in the control group (p=NS).
CONCLUSIONS: Induction Therapy with high single dose of ATG seems to be safe and efficacious in kidney transplantation.

RCT Entities:   Population Interventions Outcomes