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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

January 31, 2016

Conditions
End Stage Renal DiseaseKidney DiseaseProtein Energy Wasting
Interventions
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"

Trial Locations (6)

32809

Orlando Clinical Research Center, Orlando

37232

Vanderbilt University Medical Center, Nashville

55404

DaVita Clinical Research, Minneapolis

78215

Clinical Advancement Center, PLLC, San Antonio

80228

DaVita Clinical Research, Lakewood

98104

University of Washington, Seattle

Sponsors
All Listed Sponsors
lead

Pinta Biotherapeutics

INDUSTRY