17-HMedIdeS-14
13 evidence topics · 6 sources
Objective
Location and study date
Parent-trial treatment period
Study design
Eligibility criteria
Analysis eligibility
Treatment
No evidence found.
Study outcomes
Rationale for using long-term graft survival as the primary endpoint
Kidney function assessment
Surrogate endpoint justification for survival outcomes
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Five-year follow-up extension, NCT03611621: population
Description of analysis sets
Results
Participant disposition
Five-year assessment population
| Population | Participants |
|---|---|
| Functioning grafts with reported five-year eGFR | “24” |
Baseline characteristics
Baseline sensitization
| Characteristic | Quoted value |
|---|---|
| Median cPRA | “99.62%” |
Efficacy results
Five-year follow-up extension, NCT03611621: patient and graft survival
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Five-year follow-up extension, NCT03611621: late antibody-mediated rejection
Study limitations
Summary
This non-interventional follow-up analysis includes 39 crossmatch-positive participants from earlier trials. It is not a new randomized treatment comparison. Five-year kidney-function estimates were available for 24 functioning grafts, so these estimates are conditional on graft function and available follow-up rather than representing all original participants. The three-year, five-year, and correspondence publications concern overlapping follow-up evidence and should not be counted as separate trial populations.