- The patient has adequate renal function as defined by serum creatinine ≤ 1.5 x the institutional ULN or creatinine clearance ≥ 60 mL/min for patients with creatinine levels above the ULN, as well as urine protein ≤ 1+ on urine dipstick or routine urinalysis (if urine dipstick/routine UA indicates ≥ 2+ protein, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study)