Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting

Inclusion Criteria: * ESRD patient and on outpatient maintenance hemodialysis for ≥ 6 months * Adequate dialysis with Kt/V ≥ 1.2 on two occasions within 12 weeks of enrollment * Undergoing dialysis at least 3 times per week, on average * Serum albumin ≤ 3.8g/dL within 60 days of enrollment * Able and willing to provide Informed consent Exclusion Criteria: * Presence of an indwelling central vascular catheter * Current medical condition that would interfere with ability to perform physical function tests * Active infection requiring hospitalization or antibiotics within the past month * Major surgery within past 3 months, minor surgery within the past 4 months * Dialysis access revision/angioplasty/replacement within the past 2 weeks * History of renal transplant, whether or not functional, within 2 years (however, if graft has been removed, patient will be considered eligible) or plans to undergo renal transplantation within 6 months * History of neoplasia, except non-melanoma skin cancers, with a 30% probability of recurrence within 12 months * Current treatment with appetite stimulants, anabolic steroids or growth hormone * Clinically significant heart disease * Difficulty swallowing food or liquid * If female, currently breast feeding * If female, pregnant * If female or male, unwilling to use a highly effective method of contraception