drugset / Trial / NCT00464321
Safety Study of GC1008 in Patients With Focal Segmental Glomerulosclerosis (FSGS) of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic FSGS
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study will investigate whether GC1008, an antibody which neutralizes TGF-beta, is safe in treating patients with the disease called focal segmental glomerulosclerosis (FSGS). The highest dose without excessive side effects will be investigated. Tests will determine how long GC1008 is in the body and how it is excreted.
Timeline
- Start
- 2007-05
- Primary completion
- 2010-01
- Completion
- 2010-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fresolimumab | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Subject | Fresolimumab | Protein / enzyme biologic | 4 mg/kg | Intravenous |