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

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

Outcome

Met primary endpoint

paper Despite meeting the primary endpoint of maximum DSA reduction compared to PLEX PMID 39023092 ↗

release “In the AMR phase 2 trial (16-HMedIdes-12), imlifidase met the primary endpoint” hansabiopharma.com ↗

Publications

Halleck F, Bohmig GA, Couzi L, Rostaing L, Einecke G, Lefaucheur C, Legendre C, Montgomery R, Hughes P, Chandraker A, Wyburn K, Halloran P, Maldonado AQ, Sjoholm K, Runstrom A, Lefevre P, Tollemar J, Jordan S. A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection. Clin Transplant. 2024 Jul;38(7):e15383. doi: 10.1111/ctr.15383.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imlifidase	Protein / enzyme biologic	0.25 mg/kg	Intravenous