20-year follow-up results of a randomized controlled trial comparing antilymphocyte globulin induction to no induction in renal transplant patients.

Background: The purpose of this study was to determine the impact of antilymphocyte globulin (ALG)-induction on long-term outcomes of postrenal transplantation.

Methods: Between January 1985 and January 1986, 123 consecutive renal transplants from deceased donors were performed at a single institution. Patients were randomized into two groups: group 1 (n=63, 40+/-10 year) received cyclosporine (CsA), prednisone, and azathioprine; and group 2 (n=60, 36+/-9 year) received ALG-induction, CsA, and prednisone and delayed initiation (45-90 days posttransplantation) of azathioprine if the CsA dose was less than 4 mg/kg per day. Target CsA trough levels were 150 to 250 ng/mL. Cytomegalovirus prophylaxis was not used. Human leukocyte antigen matching (2.4+/-1.1 vs. 2.6+/-1.2) and cold ischemia time (38+/-8 hr vs. 39+/-9 hr) did not differ.

Results: The incidence of acute rejection was lower in group 2 (28% vs. 75%, P<0.0001). The incidence of cytomegalovirus infection was 10% in group 1 and 18% in group 2 (P=0.41). The incidence of cancer was 22.2% in group 1 and 11.7% in group 2 (P=0.53) and the incidence of lymphoma did not differ (3% vs. 5%, P=0.77). Patient and graft survival in groups 1 and 2 at 1, 10, and 20 years were 100%/79% vs. 100%/93%, 83%/56% vs. 88%/51%, and 64%/43% vs. 54%/47%, respectively (log-rank test, P=0.18 and P=0.078).

Conclusion: The use of ALG-induction resulted in a lower incidence of acute rejection and improved graft survival during the first year postrenal transplantation. Patient and graft survival at 20-year follow-up was not affected by ALG-induction.