End Stage Renal Disease Clinical Trial
Official title:
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
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).
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.
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