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

DINKY

8 evidence topics · 2 sources

Objective
Location and study date
Study design
Eligibility criteria
Treatment
Study outcomes
Rationale for using crossmatch conversion as the primary endpoint
Statistical analysis description
Number of participants (Planned and analyzed)
Planned enrollment in the research summary
PopulationParticipants
Planned“10”
Description of analysis sets

No evidence found.

Results
Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations
Summary

The research summary describes a single-arm pediatric trial with planned enrollment of 10 participants aged 1 to 17 years. This design does not provide a randomized comparator. No study results are included in this report, so the planned study cannot establish pediatric efficacy or safety here.