A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

September 30, 2014

Conditions
Chronic Kidney Disease
Interventions
DRUG

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.

DRUG

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.

Trial Locations (4)

78215

Clinical Advancement Center, PLLC, San Antonio

80230

Denver Nephrology, Denver

85284

Southwest Clinical Research Institute, LLC, Tempe

91942

California Institute of Renal Research, La Mesa

All Listed Sponsors
lead

La Jolla Pharmaceutical Company

INDUSTRY

NCT01843790 - A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease | Biotech Hunter | Biotech Hunter