Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

January 31, 2010

Study Completion Date

February 28, 2010

Conditions
Focal Segmental Glomerulosclerosis
Interventions
BIOLOGICAL

GC1008

1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.

BIOLOGICAL

GC1008

2 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.

BIOLOGICAL

GC1008

4 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.

BIOLOGICAL

GC1008

0.3 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.

Trial Locations (9)

Unknown

San Francisco

Rochester

Chapel Hill

Berlin

Düsseldorf

Solingen

Bergamo

Cambridge

11042-1433

New Hyde Park

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00464321 - Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS | Biotech Hunter | Biotech Hunter