Polyomavirus BK nephropathy is a new complication among renal transplant patients. We studied 664 cadaver renal transplant recipients from February 1998 to February 2005, divided into two periods: 448 (group A, February 1998 to July 2003) and 176 (group B, August 2003 to February 2005). Twenty patients (3%) developed biopsy-confirmed polyomavirus BK nephropathy; 13 (2.9%) in group A after worsening renal function and 7 (3.9%) in group B after a prospective cytologic study in urine, examining for decoy cells, and a qualitative polymerase chain reaction (PCR) assay in urine and blood. The mean time to diagnosis was higher among group A (15.0 +/- 1.6 versus 7.2 +/- 4.0 months), as was the serum creatinine (2.5 +/- 0.7 versus 2.0 +/- 0.6 mg/dL). After 12 months the serum creatinine was 2.7 +/- 1.3 versus 1.7 +/- 0.2 mg/dL, respectively. Poor prognostic factors were a persistently positive PCR in blood and viral inclusions in the control biopsy.