Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CXA-10 · 1 trial · 1 indication
overall reduction as measured by percent change from baseline
| Arm | Type | Description |
|---|---|---|
| Regimen 1 - CXA-10 75 mg | EXPERIMENTAL | Subjects in regimen 1 will start at 75 mg and may stay at 75 mg or increase to 150 mg. This treatment arm stays at 75 mg. |
| Regimen 1 - CXA-10 150 mg | EXPERIMENTAL | Subjects in regimen 1 will start at 75 mg and may stay at 75 mg or increase to 150 mg. This treatment arm increases to 150 mg. |
| Regimen 2 - CXA-10 150 mg | EXPERIMENTAL | Subjects in regimen 2 will start at 150 mg and may stay at 150 mg or increase to 300 mg. This treatment arm stays at 150 mg. |
| Regimen 2 - CXA-10 300 mg | EXPERIMENTAL | Subjects in regimen 2 will start at 150 mg and may stay at 150 mg or increase to 300 mg. This treatment arm increases to 300 mg. |
| Name | Type | Description |
|---|---|---|
| CXA-10 | DRUG | CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2) |
Inclusion Criteria: 1. have a diagnosis of primary FSGS confirmed with biopsy. 2. eGFR or 24-hour creatinine clearance ≥ 40 mL/min/1.73 m2 at Screening. 3. The subject has a Up/c ratio ≥ 2 g protein/g creatinine based on a 24 hour urine sample collected during Screening (one 24-hour collection betw...