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

Pinta Biotherapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Protein Energy Wasting

End Stage Renal Disease

Kidney Disease

Treatments

Drug: PINTA 745

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01958970

745-201

Details and patient eligibility

About

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).

Full description

This is a randomized (participants will be assigned by chance to study treatments), double-blind (participants and study personnel will not know the identity of the study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in patients who receive maintenance hemodialysis. Three participants will receive PINTA 745 for every participant that receives placebo. PINTA 745 or placebo will be taken intravenously once per week following dialysis.

The study period will consist of screening, treatment for 12 weeks, and follow up for 8 weeks. Evaluations will be performed to assess the safety, pharmacokinetics (study of what the body does to a drug), pharmacodynamics (study of what a drug does to the body) and effectiveness in treating protein energy wasting (such as increasing muscle size and muscle function) throughout the study.

Enrollment

51 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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