Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
FibroGen |
---|---|
Information provided by: | FibroGen |
ClinicalTrials.gov Identifier: | NCT00782561 |
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).
Condition | Intervention | Phase |
---|---|---|
Focal Segmental Glomerulosclerosis |
Drug: FG-3019 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 12 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
FG-3019: Experimental
FG-3019 5 mg/kg
|
Drug: FG-3019
FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks
|
Ages Eligible for Study: | 12 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Claro Arzadon | (415) 978-1332 | carzadon@fibrogen.com |
Contact: Sandy Liaw | (415) 978-1346 | sliaw@fibrogen.com |
United States, New York | |
Recruiting | |
New Hyde Park, New York, United States, 11040 | |
United States, North Carolina | |
Recruiting | |
Chapel Hill, North Carolina, United States, 27599-7155 | |
United States, Ohio | |
Recruiting | |
Columbus, Ohio, United States, 43205 |
Responsible Party: | FibroGen, Inc. ( Claro Arzadon, Clinical Research Associate ) |
Study ID Numbers: | FGCL-MC3019-026 |
Study First Received: | October 27, 2008 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00782561 History of Changes |
Health Authority: | United States: Food and Drug Administration |
steroid resistant focal segmental glomerulosclerosis FSGS adolescent focal segmental glomerulosclerosis focal segmental glomerulosclerosis |
Glomerulosclerosis, Focal Segmental Glomerulonephritis Urologic Diseases |
Focal Segmental Glomerulosclerosis Nephritis Kidney Diseases |
Glomerulosclerosis, Focal Segmental Glomerulonephritis Urologic Diseases Nephritis Kidney Diseases |