Clinical Trial Details
| Trial ID: | L6609 |
| Source ID: | NCT00913393 |
| Associated Drug: | Fg-3019 |
| Title: | Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus|Diabetic Nephropathy|Diabetic Kidney Disease |
| Interventions: | DRUG: FG-3019|DRUG: FG-3019|DRUG: Placebo |
| Outcome Measures: | Primary: Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo, 6 months | Secondary: Measure: Safety and tolerability of FG-3019 in the study population., 12 months|Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo, 6 months|Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo, 6 months |
| Sponsor/Collaborators: | Sponsor: FibroGen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 46 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2009-02 |
| Completion Date: | 2010-06 |
| Results First Posted: | |
| Last Update Posted: | 2019-02-22 |
| Locations: | Tempe, Arizona, United States|Buena Park, California, United States|Lakewood, California, United States|Sacramento, California, United States|Walnut Creek, California, United States|Whittier, California, United States|Atlanta, Georgia, United States|Evergreen Park, Illinois, United States|Topeka, Kansas, United States|Wichita, Kansas, United States|Kenner, Louisiana, United States|Springfield, Massachusetts, United States|Saint Clair Shores, Michigan, United States|Lincoln, Nebraska, United States|Omaha, Nebraska, United States|Berlin, New Jersey, United States|Buffalo, New York, United States|Flushing, New York, United States|New York, New York, United States|Greenville, North Carolina, United States|Toledo, Ohio, United States|Chattanooga, Tennessee, United States|Knoxville, Tennessee, United States|Dallas, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Fairfax, Virginia, United States|Spokane, Washington, United States |
| URL: | https://clinicaltrials.gov/show/NCT00913393 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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