Endpoints in Kidney Transplantation: Integrating Biopsy, Biomarkers & Surrogate Tools in Trials
- Combining kidney graft biopsy histology, de novo donor-specific antibodies (dnDSA), eGFR and proteinuria in a single composite biomarker panel for earlier prediction of long-term graft loss
- Positioning iBox, a composite biomarker panel, as a “reasonably likely surrogate endpoint” under FDA’s accelerated approval for immunosuppressive therapies in transplant settings
- Addressing technical and clinical challenges: assay standardization (dnDSA MFI), biopsy variability (Banff classification), and timing of assessment (first year after transplant)
- Evaluating how iBox can accelerate trials of therapies for antibody-mediated rejection and other transplant complications