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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

Positive-crossmatch deceased-donor real-world cohort

11 evidence topics · 1 source

Objective
Location and study date
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 size
PopulationParticipants
Transplanted cohort“9”
Description of analysis sets

No evidence found.

Results
Participant disposition

No evidence found.

Baseline characteristics
Baseline calculated panel-reactive antibody
CharacteristicQuoted value
Lower reported sensitization category“99%”
Higher reported sensitization category“100%”
Efficacy results
Kidney function and observation period
OutcomeQuoted value
Mean eGFR at last follow-up, mL/min/1.73 m²“56 ± 22”
Mean follow-up, months“7 ± 2.8”
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results
Study limitations
Summary

This clinical-practice cohort comprised 9 transplanted participants with at least 3 months of follow-up. The mean reported follow-up was 7 months. Crossmatch conversion occurred after one imlifidase injection, but 4 participants developed at least one infection. The small cohort and short follow-up do not establish comparative effectiveness or long-term graft survival.