Participants with stage IV-V chronic kidney disease or end stage renal disease Participants with stage V chronic kidney disease or end stage renal disease History of end-stage renal disease requiring dialysis Subjects with end-stage kidney disease and/or grade II liver dysfunction End-stage renal disease (i.e., any patient requiring or advised to undergo dialysis) Has hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score >12. End-stage liver disease unrelated to tumor End-stage renal disease: requiring hemodialysis Patients with acute hepatitis or end stage liver disease Subject has end stage renal disease and requires chronic dialysis Patients with end-stage disease, severe dementia and/or life expectancy of less than one year Patients with end-stage renal disease defined as creatinine clearance of < 15mL/min and/or diagnosed with stage 5 chronic kidney disease End stage renal disease (ESRD) Participants with end-stage liver disease (cirrhosis) Patients with end-stage disease, severe dementia and/or life expectancy of less than one year Have end stage renal disease Patients with end stage renal disease (ESRD) and/or on dialysis Have end-stage renal disease End Stage Renal Disease (ESRD) Model for end-stage liver disease (MELD) > 20 End stage renal disease with hemodialysis Has end-stage renal impairment End-stage liver disease unrelated to tumor End-stage renal disease (ESRD) on hemodialysis or CrCl ? 75 mL/min Current diagnosis of cancer, unstable cardiovascular disease, end-stage liver or kidney disease, or other major medical illness