Table 2 Study endpoints
Primary outcome | Safety and tolerability (every visit) |
Secondary outcomes | Every visit |
PK/PD of clazakizumab (antibody levels, CRP suppression) | |
Kidney function (eGFR) | |
Urinary protein excretion (protein/creatinine ratio) | |
Biopsy-proven acute rejection necessitating rejection treatment | |
Graft loss, death | |
Day 0, week 12, and week 52 | |
PK of pantoprazole | |
Cytokines and markers of endothelial activation/injury (serum, urine) | |
Effect on leukocyte subsets in peripheral blood | |
Effect on IL-6 and IL-6R gene expression in peripheral blood cells | |
DSA characteristics | |
DSA-MFI | |
Number of DSA | |
Broadness of sensitization (virtual panel-reactive antibody levels) | |
Ig classes (IgG, IgA, IgM) and IgG subclasses (IgG1, 2, 3, 4) | |
TTV load | |
Week 11 and week 51 | |
Protocol biopsy results | |
ABMR category | |
Microcirculation inflammation (glomerulitis, peritubular capillaritis) | |
Transplant glomerulopathy and interstitial fibrosis/tubular atrophy | |
Molecular ABMR score | |
Archetype analysis of gene expression profiles |