NCT03897205
12 evidence topics · 1 source
Objective
Trial indication
Location and study date
Multinational trial sites
| Characteristic | Quoted count |
|---|---|
| Transplant centers | “14” |
Study design
Eligibility criteria
Treatment
Randomized treatments
| Arm | Quoted treatment |
|---|---|
| Enzyme therapy | “imlifidase” |
| Active comparator | “PLEX” |
Study outcomes
Rationale for using donor-specific antibody reduction within five days as the primary endpoint
Statistical analysis description
Number of participants (Planned and analyzed)
Randomized population
| Population | Participants |
|---|---|
| Randomized | “Thirty” |
Description of analysis sets
Primary-endpoint analysis model
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
Post-transplant antibody-mediated rejection treatment, not pretransplant desensitization
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study limitations
Summary
This randomized study addressed treatment of established antibody-mediated rejection after transplantation, not pretransplant desensitization. Thirty participants were randomized, and the trial was open label. Greater donor-specific antibody reduction with imlifidase did not establish clinical benefit; four graft losses occurred in the imlifidase arm and one in the plasma-exchange arm. These findings should not be pooled as direct evidence for the pretransplant indication.