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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04075916 | A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients | PHASE2 | COMPLETED | 201 | — | — | Jun 22, 2021 | Feb 25, 2026 | Mar 12, 2026 | 11 | United States |
The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR-12; negative HCV RNA 12 weeks after completing Epclusa therapy)/(number of subjects treated with Epclusa post-kidney transplantation)
| Arm | Type | Description |
|---|---|---|
| Epclusa (sofosbuvir/velpatasvir) | EXPERIMENTAL | Epclusa is taken by mouth for 12 weeks as per the FDA label. |
| Name | Type | Description |
|---|---|---|
| Epclusa | DRUG | All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label. |
Inclusion Criteria: * Able to provide informed consent * Active waiting list status for isolated kidney transplant * 18 years of age or older * No living kidney donor * Panel reactive antibody (PRA) ≤97% (most recent cPRA at time of screening). Patients with a PRA of 98-100% at screening can be inc...