TABLE 1.
Component measures of the full and abbreviated iBOX.
| iBOX component measures | Detailed information on the iBOX measures |
|---|---|
| Time of posttransplant risk assessment (fixed time points) | Phase 2/proof-of-concept iBOX assessment: 6 months |
| Phase 3 iBOX assessment: 1 year, 2 years | |
| Kidney function (eGFR and UPCR proteinuria) | eGFR, where eGFR is measured in mL/min/1.73 m2 |
| Log transformed (UPCR value a ), where UPCR is measured in gram per gram (g/g) | |
| Immunological status (anti-HLA DSA MFI) | Anti-HLA DSA using a qualitative binary MFI cutoff |
| • MFI <1,400 (References group) | |
| • MFI ≥1,400 | |
| Kidney damage assessment b (kidney allograft biopsy histopathology using Banff lesion scores) | Banff lesion score, interstitial fibrosis/tubular atrophy (IFTA score): Categorical variable with 3 levels |
| • IFTA score = 0–1 (References group) | |
| • IFTA score = 2 | |
| • IFTA score = 3 | |
| Microcirculation inflammation (Banff lesion score, glomerulitis [g score] and Banff lesion score, peritubular capillaritis [ptc score]): Categorical variable with 3 levels | |
| • g and ptc score = 0–2 (References group) | |
| • g and ptc score = 3–4 | |
| • g and ptc score = 5–6 | |
| Banff lesion score, interstitial inflammation (i score) and Banff lesion score, tubulitis (t score): Categorical variable with 2 levels | |
| • i score and t score = 0–2 (References group) | |
| • i score and t score ≥3 | |
| Banff lesion score, presence/extent of glomerular base membrane double contours; transplant glomerulopathy (cg score): Categorical variable with 2 levels | |
| • cg score = 0 (References group) | |
| • cg score = ≥1 |
DSA, donor-specific antibody; eGFR, estimated glomerular filtration rate; HLA, human leukocyte antigen; MFI, mean fluorescence intensity; UPCR, urine protein-to-creatinine ratio.
For proteinuria values below 0.05 g/g are replaced by 0.05 g/g before log-transformation.
Omitted from abbreviated iBOX.