BENEFICIAL-EFFECTS OF TREATMENT OF EARLY SUBCLINICAL REJECTION - A RANDOMIZED STUDY

The prevalence of subclinical rejection, by the Banff criteria, is app roximately 30% in the first 3 mo in renal transplant recipients. A ran domized study was performed to determine whether the treatment of subc linical rejection with corticosteroids was associated with improved ou tcomes in these patients. Seventy-two patients, stratified by donor so urce, were randomized to biopsies at 1, 2, 3, 6, and 12 mo (Biopsy gro up), or to 6- and 12-mo biopsies only (Control group). Patients were a nalyzed by ''intent to treat'' and were followed for a minimum of 2 yr . Patients in the Biopsy arm of the study had a significant decrease i n early (months 2 and 3) and late (months 7 to 12) acute rejection epi sodes, a reduced chronic tubulointerstitial score at 6 mo, and a lower serum creatinine at 24 mo than did patients in the Control arm. There was a trend toward an increase in infectious morbidity, but no increa se in mortality, in the patients randomized to the Biopsy group. The r esults of this study suggest that early protocol biopsies and the trea tment of subclinical rejection with corticosteroids may lead to better histologic and functional outcomes in renal transplant recipients.