Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts

Phase 3 Completed 113 enrolled Hansa Biopharma AB

Non-randomizedParallel-groupOpen-labelTreatment

Summary

An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease (ESRD) patients with positive crossmatch (XM) against a deceased donor prior to desensitized with imlifidase and subsequent kidney transplantation. Two non-comparative reference cohorts are included to assess the impact of differences in post-transplantation management and outcome in less sensitized patients.

Timeline

Start: 2022-04-19
Primary completion: 2026-04-21
Completion: 2026-04-21

Outcome

Met primary endpoint

release “ConfIdeS trial, where imlifidase met its primary endpoint of eGFR at 12 months in kidney transplantation.” hansabiopharma.com ↗

Publications

Vo A, Ammerman N, Jordan SC. New Therapies for Highly Sensitized Patients on the Waiting List. Kidney360. 2024 Aug 1;5(8):1207-1225. doi: 10.34067/KID.0000000000000509. Epub 2024 Jul 12.

Drugs

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

Indications

No indication recorded.