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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01665391 | A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS) | PHASE2 | COMPLETED | 36 | — | — | Aug 1, 2012 | Nov 1, 2014 | Aug 26, 2015 | 32 | United States, Brazil +3 |
| Arm | Type | Description |
|---|---|---|
| fresolimumab 1 mg/kg total body weight | EXPERIMENTAL | - |
| fresolimumab 4 mg/kg total body weight | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| fresolimumab | DRUG | 1 mg/kg total body weight administered intravenous (IV) |
| Placebo | DRUG | Placebo administered to match active treatment group |
Inclusion Criteria: * The patient's renal biopsy is consistent with the diagnosis of primary Focal Segmental Glomerulosclerosis (FSGS) including all histological subtypes. * The patient has an eGFR ≥ 30 mL/min/1.73 m2 * The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg crea...