Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00754143 | Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy | PHASE1 | COMPLETED | 38 | — | — | Mar 1, 2008 | Dec 1, 2009 | Aug 2, 2019 | 18 | United States |
| NCT00102297 | Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 20 | — | — | Jan 1, 2005 | Jun 1, 2007 | Dec 12, 2007 | 5 | United States |
| Arm | Type | Description |
|---|---|---|
| A | PLACEBO_COMPARATOR | Placebo |
| B | EXPERIMENTAL | FG-3019 5 mg/kg |
| C | EXPERIMENTAL | FG-3019 10 mg/kg |
| Name | Type | Description |
|---|---|---|
| FG-3019 | DRUG | Placebo every 2 weeks IV for all infusions |
Inclusion Criteria: 1. Age 18-80 years, inclusive 2. Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria 3. First morning urinary ACR \>0.200 g/g 4. Receiving stable doses of ACEi and/or ARB therapy prior to Screening 5. Estimated glomerular filtration r...