- Patient has liver function tests > 3.0 times the upper limit of normal, serum creatinine > 1.8 mg/dL for females and >2.0 mg/dL for males and a eGFR value <30 mL/min/1.73 m2. Enrollment of patients with eGFR values of between 30 and 59 mL/min/1.73 m2 will be left to the discretion of the investigator. Patients with abnormal laboratory values which are deemed clinically significant by the investigator will not be enrolled.