Effect of antilyphocyte-globulin potency on survival of cadaver renal transplants. Prospective randomised double-blind trial.
71 recipients of cadaver primary and secondary renal transplants were investigated in a prospective randomised double-blind study. Patients were given one of two rabbit antilymphocyte globulin (A.L.G.) preparations made by similar techniques but differing in potency as measured by skin-graft prolongation in rhesus monkeys. Patient selection and management were otherwise similar. A statistically significant difference (P less than 0-05) in graft survival (78% vs. 42%) developed between the two groups at a mean follow-up of 18-4 months and patient entry into the study was terminated. After a 3-5 year interval from the start of the trial the double-blind code was broken. It was found that the high-potency-A.L.G. group had better graft survival and fewer rejection episodes (P less than 0-05) than the moderate-potency group. The results suggest that preclinical testing of A.L.G. by the primate skin graft test can be a valid indicator of the potential efficacy of an A.L.G. preparation in renal-transplant recipients. It is suggested that quality-control standards may improve the clinical results of A.L.G. therapy.
D000293:Adolescent; D000328:Adult; D000818:Animals; D000961:Antilymphocyte Serum / Q000592:standards* / Q000627:therapeutic use; D002102:Cadaver; D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival; D000882:Haplorhini; D006801:Humans; D016030:Kidney Transplantation; D008253:Macaca mulatta; D008875:Middle Aged; D011446:Prospective Studies; D011786:Quality Control; D011817:Rabbits; D012712:Serum Globulins / Q000592:standards* / Q000627:therapeutic use; D013997:Time Factors; D014184:Transplantation, Homologous
D000961:Antilymphocyte Serum; D012712:Serum Globulins