Clinical Trial Details
| Trial ID: | L4786 |
| Source ID: | NCT00754143 |
| Associated Drug: | Fg-3019 |
| Title: | Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus|Diabetic Nephropathy |
| Interventions: | DRUG: FG-3019|DRUG: FG-3019|DRUG: FG-3019 |
| Outcome Measures: | Primary: Safety and tolerability of FG-3019, 34 weeks | Secondary: Pharmacokinetic parameters, 34 weeks|Change from baseline in first morning urinary albumin creatinine ratio (ACR), 6 weeks (10 mg/kg) or 10 weeks (5 mg/kg) |
| Sponsor/Collaborators: | Sponsor: FibroGen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 38 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-03 |
| Completion Date: | 2009-12 |
| Results First Posted: | |
| Last Update Posted: | 2019-08-02 |
| Locations: | Birmingham, Alabama, United States|Tempe, Arizona, United States|La Mesa, California, United States|Torrance, California, United States|Kissimmee, Florida, United States|Atlanta, Georgia, United States|Springfield, Massachusetts, United States|Omaha, Nebraska, United States|Flushing, New York, United States|New York, New York, United States|Chapel Hill, North Carolina, United States|Cleveland, Ohio, United States|Portland, Oregon, United States|Hershey, Pennsylvania, United States|Dallas, Texas, United States|Houston, Texas, United States|San Antonio, Texas, United States|Fairfax, Virginia, United States |
| URL: | https://clinicaltrials.gov/show/NCT00754143 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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