Study 435 Post-Transplantation Patients with Confirmed Increases in Serum Creatinine ? 0.5 mg/dL from Baseline (n=26)
Concomitant cyclosporine or tacrolimus (n=26)
Pre-existing medical condition placing patient at risk for renal dysfunction (n=11)
Pre-existing renal impairment (CLcr< 50 mL/min) (n=8)
Decompensated cirrhosis at baseline (n=4) or disease progression during treatment (n=6)
Acute intercurrent medical event prior to onset of serum creatinine increase (n=13)
Other concomitant nephrotoxic agents administered just prior to event (n=2)
Through NDA Safety Update