ConfIdeS

15 evidence topics · 4 sources

Objective

Kidney function objective

“12-month kidney function” (opens the source at this quote in a new tab)

Location and study date

Participating sites

“25 U.S. sites” (opens the source at this quote in a new tab)

Study design

ConfIdeS, NCT04935177: design

“pivotal Phase 3 open label, randomized, controlled trial” (opens the source at this quote in a new tab)

Randomization ratio

“1:1” (opens the source at this quote in a new tab)

Eligibility criteria

Crossmatch eligibility

“positive crossmatch against a deceased donor” (opens the source at this quote in a new tab)

Treatment

ConfIdeS, NCT04935177: control-arm treatments

“any combination of PLEX, IVIG, anti-CD20, eculizumab, or waiting a more compatible organ” (opens the source at this quote in a new tab)

Immunosuppression in the imlifidase arm

“rabbit anti-thymocyte globulin induction” (opens the source at this quote in a new tab)
“corticosteroids, mycophenolic acid, and tacrolimus” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using estimated glomerular filtration rate at 12 months as the primary endpoint

Primary endpoint

“eGFR at 12 months” (opens the source at this quote in a new tab)

Validation of the primary endpoint as a surrogate for long-term clinical benefit

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

ConfIdeS, NCT04935177: randomized population

“64 highly sensitized (cPRA ≥99.9%)” (opens the source at this quote in a new tab)

Description of analysis sets

No evidence found.

Results

Participant disposition

Timing of transplantation

Disposition	Participants
Imlifidase arm: transplanted at randomization	“28”
Control arm: transplanted at randomization	“3”
Control arm: additional later transplants	“12”

Baseline characteristics

No evidence found.

Efficacy results

ConfIdeS, NCT04935177: primary endpoint results

“At 12 months, mean eGFR was 51.5 mL/min/1.73m[2] in the imlifidase arm versus 19.3 mL/min/1.73m[2] in the control arm” (opens the source at this quote in a new tab)
“p<0.0001” (opens the source at this quote in a new tab)

ConfIdeS, NCT04935177: dialysis dependence

“Dialysis dependence was greater in the control arm (56% vs 16%; p=0.0007).” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

ConfIdeS, NCT04935177: antibody-mediated rejection

“16/28 patients in the imlifidase arm (57%)” (opens the source at this quote in a new tab)
“6/13 in the control arm (46%)” (opens the source at this quote in a new tab)

Treatment-emergent adverse events and patient survival

Outcome	Quoted result
Treatment-emergent adverse events, total events	“386”
Patient survival: imlifidase	“97%”
Patient survival: control	“100%”

Study limitations

Summary

ConfIdeS randomized 64 participants but was open label, and its control arm allowed several desensitization approaches or continued waiting. The comparison therefore does not isolate imlifidase against one standardized active regimen. The rejection counts use denominators of 28 and 13 rather than the complete randomized population, so they should not be interpreted as randomized-population rejection risks. The reported primary comparison concerns kidney function at 12 months, not a demonstrated long-term survival benefit.