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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: End Stage Renal Disease, Kidney Disease, Protein Energy Wasting

In brief

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).

Key facts

Study ID

NCT01958970

Run by

Pinta Biotherapeutics

People needed

51

Starts

2014-01-01

Expected to finish

2016-01-01

Last updated by the study team

2018-04-11

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• DaVita Clinical Research — Lakewood, Colorado, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• DaVita Clinical Research — Minneapolis, Minnesota, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Clinical Advancement Center, PLLC — San Antonio, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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