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Imlifidase

Kidney transplantation in highly sensitized patients

Manufacturer
Hansa Biopharma
Regulatory submission
BLA submitted December 2025
Last updated
85 sources

Clinical evidence

High-strength donor-specific antibody single-center cohort

10 evidence topics · 1 source

Objective
Location and study date

No evidence found.

Study design
Eligibility criteria
Treatment
Study outcomes
Rationale for using crossmatch conversion as the primary endpoint

Not applicable.

Statistical analysis description
Number of participants (Planned and analyzed)
Reported cohort
PopulationParticipants
Transplant candidates“7”
Description of analysis sets

No evidence found.

Results
Participant disposition

No evidence found.

Baseline characteristics
Baseline sensitization and donor type
CharacteristicQuoted value
Calculated panel-reactive antibody range“cPRA98-100%”
Deceased donors“5”
Living donors“2”
Efficacy results
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results
Study limitations
Summary

This single-center report describes 7 participants, including 5 deceased-donor and 2 living-donor transplant recipients. All had functioning grafts at a median follow-up of 235 days, but 3 experienced antibody rebound and antibody-mediated rejection. The small series does not provide a randomized comparator. Its participants should not be assumed to be independent of other trial or follow-up publications without confirmation of participant overlap.