120
Participants
Start Date
June 30, 2013
Primary Completion Date
February 28, 2014
Study Completion Date
September 30, 2014
GCS-100
The amount (in mg) of GCS-100 to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The study drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.
Placebo, Saline
The amount (in mg) of drug to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.
Clinical Advancement Center, PLLC, San Antonio
Denver Nephrology, Denver
Southwest Clinical Research Institute, LLC, Tempe
California Institute of Renal Research, La Mesa
Lead Sponsor
La Jolla Pharmaceutical Company
INDUSTRY