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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04536688 | A Study of RGLS4326 in Patients With Autosomal Dominant Polycystic Kidney Disease | PHASE1 | COMPLETED | 19 | — | — | Oct 13, 2020 | Nov 12, 2021 | Dec 15, 2021 | 12 | United States |
Changes in polycystin-1 (PC-1) and polycystin-2 (PC-2) protein levels in urinary exosomes from baseline to Day 44
| Arm | Type | Description |
|---|---|---|
| RGLS4326 1 mg/kg Q2W | EXPERIMENTAL | Eligible participants will receive subcutaneous injection of 1 mg/kg of RGLS4326 every other week for 4 doses |
| RGLS4326 0.3 mg/kg Q2W | EXPERIMENTAL | Eligible participants will receive subcutaneous injection of 0.3 mg/kg of RGLS4326 every other week for 4 doses |
| RGLS4326 0.1 or 0.5 mg/kg Q2W | EXPERIMENTAL | Eligible participants will receive subcutaneous injection of 0.1 or 0.5 mg/kg of RGLS4326 every other week for 4 doses |
| Name | Type | Description |
|---|---|---|
| RGLS4326 | DRUG | Solution for subcutaneous injection |
Inclusion Criteria: * Male or female ADPKD patients 18 to 70 years old * Class 1C, 1D, or 1E Mayo Imaging Classification of ADPKD (based upon prior MRI or CT Scan or MRI obtained during screening) * Estimated GFR at Screening between 30 to 90 mL/min/1.73 m\^2 calculated by the investigator using th...