20-HMedIdeS-19

14 evidence topics · 2 sources

Objective

Post-authorization efficacy objective

“one‑year graft failure‑free survival” (opens the source at this quote in a new tab)

Location and study date

Recruitment and geographic coverage

Study characteristic	Quoted record
First participant enrolled	“May 2022”
Participating transplant centers	“22”
Participating countries	“11”

Study design

Reference-group design

“Non-comparative concurrent” (opens the source at this quote in a new tab)

Eligibility criteria

Recipient eligibility

Criterion	Quoted value
Recipient age range, years	“18-75”
Sensitization threshold	“≥95%”

Treatment

Pretreatment before transplantation

“Idefirix pre‑treatment” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using graft failure-free survival at one year as the primary endpoint

Primary endpoint result

“The 1-year graft failure-free survival was 90%” (opens the source at this quote in a new tab)

Validation against a randomized comparator

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

European post-authorization efficacy study: enrollment

“A total of 51 patients were enrolled” (opens the source at this quote in a new tab)

Description of analysis sets

Analysis sets in the sponsor presentation

Population	Imlifidase	Concurrent reference
Safety analysis set	“51 (100)”	“63 (100)”
Intention-to-treat analysis set	“50 (98.0)”	“63 (100)”

Results

Participant disposition

Trial completion in the sponsor presentation

Disposition	Imlifidase	Concurrent reference
Completed trial	“48 (94.1)”	“57 (90.5)”

Baseline characteristics

Baseline age in the sponsor presentation

Characteristic	Imlifidase	Concurrent reference
Mean age, years	“50.1”	“55.6”

Efficacy results

European post-authorization efficacy study: one-year outcomes

“The 1-year graft failure-free survival was 90%” (opens the source at this quote in a new tab)
“graft survival was 92%, and patient survival was 98%.” (opens the source at this quote in a new tab)

One-year kidney function in the results announcement

Outcome	Quoted value
Mean eGFR, mL/min/1.73 m²	“52.4”

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Serious treatment-emergent adverse events in the sponsor presentation

Population	Participants
Imlifidase safety population with serious treatment-emergent adverse events	“28 (54.9)”

Study limitations

Summary

The presentation distinguishes a safety population of 51 imlifidase-treated participants from an intention-to-treat population of 50. Its concurrent reference cohort is explicitly non-comparative, so the reported outcomes do not constitute a randomized comparative-effectiveness estimate. Forty-eight imlifidase-treated participants completed the trial. The one-year results do not resolve longer-term graft outcomes.