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| Sponsor: | FibroGen |
|---|---|
| Information provided by: | FibroGen |
| ClinicalTrials.gov Identifier: | NCT00754143 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Diabetic Nephropathy |
Drug: FG-3019 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study of Safety, Pharmacokinetics and Pharmacodynamics of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy on Background ACEi and/or ARB Therapy |
| Estimated Enrollment: | 36 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Placebo Comparator
Placebo
|
Drug: FG-3019
Placebo every 2 weeks IV for all infusions
|
|
B: Experimental
FG-3019 5 mg/kg
|
Drug: FG-3019
FG-3019 5 mg/kg every 2 weeks IV for all infusions
|
|
C: Experimental
FG-3019 10 mg/kg
|
Drug: FG-3019
FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Tempe, Arizona, United States | |
| United States, California | |
| La Mesa, California, United States | |
| Torrance, California, United States | |
| United States, Florida | |
| Kissimmee, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| United States, Massachusetts | |
| Springfield, Massachusetts, United States | |
| United States, Nebraska | |
| Omaha, Nebraska, United States | |
| United States, New York | |
| Flushing Queens, New York, United States | |
| New York, New York, United States | |
| United States, North Carolina | |
| Chapel Hill, North Carolina, United States | |
| United States, Ohio | |
| Cleveland, Ohio, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| San Antonio, Texas, United States | |
| Dallas, Texas, United States | |
| United States, Virginia | |
| Fairfax, Virginia, United States | |
More Information
| Responsible Party: | FibroGen, Inc. ( Sandy Liaw, Senior Clinical Program Manager ) |
| Study ID Numbers: | FGCL-3019-029 |
| Study First Received: | September 15, 2008 |
| Last Updated: | July 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00754143 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Type 1 or Type 2 diabetes proteinuria |
|
Metabolic Diseases Diabetic Nephropathies Urologic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Kidney Diseases Glucose Metabolism Disorders Diabetes Complications |