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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03373786 | A Study of RG-012 in Subjects With Alport Syndrome | PHASE1 | COMPLETED | 4 | — | — | Dec 22, 2017 | May 20, 2019 | Apr 25, 2022 | 7 | United States |
Incidence and severity of adverse events
Change in miR-21 expression in renal tissue
| Arm | Type | Description |
|---|---|---|
| RG-012 Single Dose | EXPERIMENTAL | 1.5 mg/kg RG012 subcutaneous injection |
| RG012 Every Other Week | EXPERIMENTAL | 1.5 mg/kg RG012 subcutaneous injections every other week |
| Name | Type | Description |
|---|---|---|
| RG012 | DRUG | RG012 in 0.3% sodium chloride |
Inclusion Criteria: 1. Males or females, ages 18 to 65 years 2. Confirmed diagnosis of Alport syndrome 3. eGFR between 40 and 90 mL/min/1.73m2 4. Proteinuria of at least 300 mg protein/g creatinine 5. For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable for at least 3...