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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to assess the safety, pharmacokinetics and effectiveness of PINTA 745 or placebo in treating protein energy wasting (PEW) in patients receiving maintenance hemodialysis (MHD).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pinta Biotherapeutics

Criteria

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