drugset / Trial / NCT04935177
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
RandomizedParallel-groupOpen-labelTreatment
Summary
An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care
Timeline
- Start
- 2021-10-14
- Primary completion
- 2025-06-20
- Completion
- 2025-06-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imlifidase | Protein / enzyme biologic | 0.25 mg/kg | Intravenous |
| Background | Eculizumab | Monoclonal antibody | — | — |
| Background | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Intravenous |
| Background | Rituximab | Monoclonal antibody | — | — |
Indications
No indication recorded.