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Identification of pathological events in the renal allograft using protocol biopsies at predetermined time intervals may yield useful information and improve outcomes. We examined the influence of decisions taken on the basis of 1 and 3-month protocol biopsies findings on 1-year renal allograft function in a prospective randomized study. Out of 102 living-donor allograft recipients, 52 were randomized to undergo protocol biopsies and 50 controls had only indicated biopsies. All acute rejection episodes (clinical and subclinical) were treated. CNI dose adjustments were made on clinical judgement. Baseline recipient and donor characteristics, immunosuppressive drug usage, HLA matches, and 2-hour cyclosporine levels were similar in both groups. At 1 and 3 months, protocol biopsies revealed borderline changes in 11.5% and 14% patients, acute rejection in 17.3% and 12%, and chronic allograft nephropathy in 3.8% and 10%. The incidence of clinically evident acute rejection episodes was similar in the two groups, but biopsy group had lower serum creatinine at 6-months (P=0.0003) and 1-year (P< 0.0001). The creatinine values were similar in those with normal histology and borderline changes. Protocol biopsies are helpful in detecting subclinical histological changes in the graft; and management decisions based on this information improve short-term renal allograft function. [ABSTRACT FROM AUTHOR]