drugset / Trial / NCT03897205
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an active or chronic active antibody mediated rejection (AMR) after being kidney transplanted. The purpose was also to investigate and compare safety for these two treatments.
Timeline
- Start
- 2019-04-30
- Primary completion
- 2022-05-28
- Completion
- 2022-11-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imlifidase | Protein / enzyme biologic | 0.25 mg/kg | Intravenous |