NCT01958970

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Pinta Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• End Stage Renal Disease
• Kidney Disease
• Protein Energy Wasting

Interventions

Type	Name	Description
DRUG	PINTA 745	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
DRUG	Placebo	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

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2013-10-09
• Last updated: 2018-04-11

Locations

6 sites across 1 country: United States