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.
Patients in each cohort will receive a single dose of GC1008 infusion at 1, 2, 4 or 0.3 mg/kg body weight. The higher dose cohort will not start until the first 28 days safety data for the lower dose cohort have been reviewed by the independent Data Monitoring Committee (DMC). Cohort C and D will run concurrently with patients randomised to receive either a 4 or 0.3 mg/kg body weight dose, respectively. After receiving the infusion of GC1008 on Day 0, patients will be monitored for the 24 hours following the infusion. Patients will return periodically over the following 112 days for safety evaluations and clinical outcome assessments. Blood samples will be collected to evaluate the pharmacokinetics of single dose administration of GC1008 as well as for evaluation of markers of clinical efficacy
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
1 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
2 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
4 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
Unnamed facility
San Francisco, California, United States
Unnamed facility
Rochester, Minnesota, United States
Unnamed facility
New Hyde Park, New York, United States
Unnamed facility
Chapel Hill, North Carolina, United States
To determine Safety and tolerability of single dose infusions of GC1008 in patients with treatment resistant idiopathic FSGS and nephrotic range proteinuria
Time frame: up to 2 years
Pharmacokinetics of GC1008 following a single dose infusion
Time frame: up to 2 years
To investigate Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy.
Time frame: up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0.3 mg/kg, IV infusion on Day 0 and monitored over 24 hours. Post infusion for safety up to 112 days.
Unnamed facility
Berlin, Germany
Unnamed facility
Düsseldorf, Germany
Unnamed facility
Solingen, Germany
Unnamed facility
Bergamo, Italy
Unnamed facility
Cambridge, United Kingdom