EFFICACY END-POINTS CONFERENCE ON ACUTE REJECTION IN KIDNEY-TRANSPLANTATION - SUMMARY REPORT OF THE DATABASE

An international database of rejection episodes and their characterist ics with regard to definition and follow-up parameters was developed t o improve the approach to protocol development far clinical trials. Ni neteen North American, European, and Australian centers uniformly repo rted on 50 consecutive transplant rejection episodes. Data collected i ncluded patient demographic parameters, induction and maintenance immu nosuppression therapies, rejection agents (drug, dose, duration), clin ical signs (50% decrease in urine, fever), serum creatinine (nadir, at rejection, dairy during antirejection therapy to 15 days, and days 30 , 90, 180, and 365 after rejection date), histopathological findings, morbidity, recurrence of rejection, and function at 1 year. The center s contributed a total of 953 presumed rejection episodes, of which 842 were confirmed as acute rejection episodes. The majority of cases wer e first rejections (81%), and rejection occurred 119 +/- 345 days foll owing transplantation. The Banff Schema of histological grading was us ed in 38% of biopsy-proven rejection episodes (2% Borderline, 42% Grad e I, 38% Grade II, 18% Grade III). Only 30% of all rejections showed c linical signs that were most likely to occur in Grade II rejection epi sodes (P < 0.006), The serum creatinine response was well below the re jection creatinine level by day 15 following initiation of antirejecti on therapy in the majority of cases. A significant number of the cases (34%) reported in this database experienced a recurrent rejection app roximately 85 days following the first rejection. Graft survival 1 yea r following the rejection episode was good (83%). These findings will facilitate development of clinical trial design and beneficially impac t approaches to antirejection therapies for kidney allograft recipient s. (C) 1998 by the National Kidney Foundation, Inc.