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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04123613 | Multiple Doses of DM199 in Patients With Chronic Kidney Disease (REDUX) | PHASE2 | COMPLETED | 79 | — | — | Dec 17, 2019 | Mar 16, 2022 | Mar 31, 2022 | 14 | United States |
Incidence, severity, and causality of adverse events
eGFR
UACR change from baseline
Maximum plasma concentration of DM199
| Arm | Type | Description |
|---|---|---|
| 2.0 µg/kg, multiple dose | EXPERIMENTAL | n=45 with 15 Participants from cohort 1, 15 from cohort 2, and 15 from cohort 3 |
| 5.0 µg/kg, multiple dose | EXPERIMENTAL | n=45 with 15 Participants from cohort 1, 15 from cohort 2 and 15 from cohort 3 |
| Name | Type | Description |
|---|---|---|
| DM199 | DRUG | A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug |
Inclusion Criteria: Cohort I * African American * Hypertension as defined by the American Heart Association for Stage I hypertension where systolic blood pressure (BP) ≥130 mmHg or diastolic BP ≥ 80 mmHg or on medication for treatment of hypertension. Cohort II * IgA nephropathy confirmed by med...