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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I, Multicentre, Open-label, Dose-escalating Study of Single Doses of GC1008 in Patients With Treatment Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSG

Brief 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.

Detailed Summary: 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
Sponsor: Genzyme, a Sanofi Company

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • Safety and tolerability of single dose infusions of GC1008
  • Pharmacokinetics of GC1008 following a single dose infusion


Current Secondary Outcome: To investigate Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy. [ Time Frame: up to 2 years ]

Original Secondary Outcome: Effect of single dose infusions of GC1008 on biomarkers of clinical efficacy.

Information By: Sanofi

Dates:
Date Received: April 20, 2007
Date Started: May 2007
Date Completion:
Last Updated: March 17, 2014
Last Verified: March 2014