Clinical Trial: Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).
Detailed Summary:
Sponsor: FibroGen
Current Primary Outcome: Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications [ Time Frame: 32 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Standard plasma and urinary PK parameters [ Time Frame: 32 weeks ]
- Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: FibroGen
Dates:
Date Received: October 27, 2008
Date Started: April 2008
Date Completion: March 2011
Last Updated: July 14, 2009
Last Verified: July 2009
