Evicenter
P&T meetings

Imlifidase

Kidney transplantation in highly sensitized patients

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

Clinical evidence

Lupus nephritis retransplantation case report

8 evidence topics · 1 source

Objective
Location and study date

No evidence found.

Study design
Eligibility criteria

Not applicable.

Treatment
Study outcomes
Rationale for using donor-specific antibody reduction as the primary endpoint

Not applicable.

Statistical analysis description
Number of participants (Planned and analyzed)
Description of analysis sets

Not applicable.

Results
Participant disposition

No evidence found.

Baseline characteristics
Baseline features
CharacteristicQuoted record
Underlying kidney disease“lupus nephritis”
Sensitization“cPRA>99 %”
Efficacy results
Maximum reported total IgG depletion at 36 hours
OutcomeQuoted value
Total IgG reduction from baseline“-75 %”
Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations
Summary

The report concerns one 51-year-old woman with lupus nephritis undergoing retransplantation. The absence of donor-specific antibody rebound at six months is an individual observation, not an estimate of response probability. The case does not establish comparative efficacy or safety in other highly sensitized transplant candidates.