Clinical Studies

phase I

FibroGen completed a phase 1 study of FG-3019, a fully human monoclonal antibody against CTGF, in patients with diabetes and microalbuminuria. Results of this open-label study demonstrated FG-3019 to be well tolerated and a rapid decline in albuminuria.1,2 FibroGen has completed the treatment phase of a placebo-controlled phase 1 study in patients with diabetes and macroalbuminuria, an a environment where both fibrosis and proteinuria play key roles in the destruction of the kidney in diabetic patients. Follow-up with patients will be completed by the end of 2009.

References

  1. Schwartz, S., et al. (2007) Phase 1 study of FG-3019, an anti-CTGF monoclonal antibody, in type 1/2 diabetes mellitus with microalbuminuria. Diabetes Vol. 56, Suppl.1; A151.
  2. Adler, S.G., et al. (2006) Dose-escalation phase 1 study of FG-3019, anti-CTGF monoclonal antibody, in patients with type 1/2 diabetes mellitus and microalbuminuria. JASN 17:157A.

phase II

FibroGen has initiated enrollment in a phase 2 clinical trial designed to evaluate the efficacy and safety of FG-3019 in patients with type 2 diabetes and advanced kidney disease.Read more

References

  1. Schwartz, S., et al. (2007) Phase 1 study of FG-3019, an anti-CTGF monoclonal antibody, in type 1/2 diabetes mellitus with microalbuminuria. Diabetes Vol. 56, Suppl.1; A151.
  2. Adler, S.G., et al. (2006) Dose-escalation phase 1 study of FG-3019, anti-CTGF monoclonal antibody, in patients with type 1/2 diabetes mellitus and microalbuminuria. JASN 17:157A.
   

 
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