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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05521191 | A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease | PHASE1 | COMPLETED | 68 | — | — | Oct 6, 2022 | Mar 27, 2025 | Jun 3, 2025 | 21 | United States |
Incidence of adverse events over time
Change from baseline in PC1, PC2, NGAL, and KIM-1 urine biomarkers
| Arm | Type | Description |
|---|---|---|
| RGLS8429 | EXPERIMENTAL | The randomized,double blind part of the study (Part A) will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). * Cohort 1: first dose level of RGLS8429 or placebo * Cohort 2: second dose level of RGLS8429 or placebo * Cohort 3: third dose level of RGLS8429 or placebo |
| Placebo | EXPERIMENTAL | The randomized double blind part of the study (Part A) will consist of three sequential cohorts of approximately 12 subjects each randomized centrally to receive RGLS8429 or placebo by subcutaneous injection every other week (Q2W) x 7 doses (36 subjects total). * Cohort 1: first dose level of RGLS8429 or placebo * Cohort 2: second dose level of RGLS8429 or placebo * Cohort 3: third dose level of RGLS8429 or placebo |
| Open Label Fixed Dose RGLS8429 | EXPERIMENTAL | The open-label fixed dose part of the study (Part B and Cohort 4) will consist of a single cohort of up to 30 subjects each receiving 300 mg RGLS8429. |
| Name | Type | Description |
|---|---|---|
| RGLS8429 | DRUG | Solution for subcutaneous injection |
| Placebo | DRUG | Solution for subcutaneous injection |
Key Inclusion Criteria: 1. Male or female ADPKD patients, 18 to 70 years old 2. Class 1C, 1D, or 1E Mayo Imaging Classification of ADPKD (based upon either the MRI obtained during screening, or a prior MRI obtained within 5 years of screening with documented Mayo classification) 3. eGFR between 30 ...