Title
Effects of PINTA 745 in End Stage Renal Disease (ESRD) Patients Who Require Hemodialysis and Have Protein Energy Wasting
A Randomized, Double-blind, Pilot Study of PINTA 745, an Anti-myostatin Peptibody, in Patients With End Stage Renal Disease Who Require Maintenance Hemodialysis and Have Protein Energy Wasting
Phase
Phase 1/Phase 2Lead Sponsor
Pinta BiotherapeuticsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
End Stage Renal Disease Kidney Disease Protein Energy WastingIntervention/Treatment
pinta 745 ...Study Participants
51This 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).
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.
PINTA 745 will be administered once weekly by IV infusion. Cohort dose schedules: 3mg/kg weekly for 12 weeks 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks
Placebo will be administered once weekly by IV infusion. Cohort dose schedules: 3mg/kg weekly for 12 weeks 3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks 6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks
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
