drugset / Trial / NCT03897205

An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

NCT03897205

Phase 2 Completed 30 enrolled Hansa Biopharma AB
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

EvaluationDrugModalityDoseRoute
Subject Imlifidase Protein / enzyme biologic 0.25 mg/kg Intravenous

Indications