TABLE 6.
Study | Trial ID | Design | Clinical scenario | Target population | n | Time post-transplant (y) of risk score evaluation median, IQR | Follow-up time post-transplant (y) median, IQR | Risk score C-stat |
---|---|---|---|---|---|---|---|---|
CERTITEM (64) | NCT 01079143 | Prospective, randomized, open‐label, multicentre trial | Immuno-suppressive drug minimization | Recipients of renal transplants from a living or deceased donor | 194 | 0.94 | 6.62 | 0.88 |
0.92–0.98 | 2.82–7.34 | |||||||
RITUX ERAH (63) | EudraCT 2007-003213-13 | Prospective, randomized, multicentre, double-blind, placebo-controlled trial | AMR treatment (pre-existing DSA) | Recipients of renal transplants from a living or deceased donor with diagnosis of aAMR | 38 | 0.74 | 6.63 | 0.77 |
0.53–1.10 | 4.03–7.69 | |||||||
BORTEJECT (62) | NCT 01873157 | Prospective, randomized, placebo-controlled, double-blind, single-center trial | AMR treatment (dnDSA) | Recipients of renal transplants from a living or deceased donor with post-transplant dnDSA detection | 44 | 6.61 | 7.75 | 0.94 |
4.04–15.41 | 5.32–16.41 |
A, acute/active; AMR, antibody-mediated rejection; dn, de novo; DSA, donor-specific antibodies; IQR, interquartile range.