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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05092347 | A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA) | PHASE1 | ACTIVE NOT_RECRUITING | 43 | — | — | Aug 2, 2022 | Nov 22, 2027 | Jun 2, 2026 | 10 | United States |
TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)
| Arm | Type | Description |
|---|---|---|
| Vonsetamig | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Vonsetamig | DRUG | Administered by intravenous (IV) infusion |
Key Inclusion Criteria: 1. Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA \>98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist, as defined in the prot...