Table 2B.
Immunological Risk stratification in test and validations cohorts.
| Group | Number patients | Low % patients |
Standard % patients |
High % patients |
|---|---|---|---|---|
| Total patients used from KALIBRE study | ||||
| KTRs (all) | 248 | 26.6 | 56.9 | 16.5 |
| Rejectors (all) | 66 | 22.7 | 63.6 | 13.6 |
| Signature development patients (KALIBRE study) | ||||
| Rejectors (TCMR) | 27 | 37.0 | 55.6 | 7.4 |
| Stable (Discovery)* | 27 | 33.3 | 66.7 | 0 |
| BKVN* | 7 | 14.3 | 85.7 | 0 |
| Cross-sectional validation patients (KALIBRE study) | ||||
| Category 1 | 8 | 50.0 | 37.5 | 12.5 |
| Category 3 | 33 | 27.3 | 57.6 | 15.2 |
| Category 5 | 10 | 30.0 | 60.0 | 10.0 |
| Category 6 | 38 | 42.1 | 50.0 | 7.9 |
| Rejectors (Mixed-type) | 9 | 0 | 88.9 | 11.1 |
| Stable (Validation)* | 17 | 29.4 | 58.8 | 11.8 |
| Rejectors (Rituximab/Alemtuzumab) | 10 | 0 | 60·0 | 40.0 |
| Longitudinal validation patients (KALIBRE study) | ||||
| Rejectors (TCMR + Mixed) | 51 | 27.5 | 64.7 | 7.8 |
| Stable (Validation) + Non-rejectors (Basiliximab) | 52 | 34.6 | 57.7 | 7.8 |
| Non-rejectors (Basiliximab) | 35 | 37.1 | 57.1 | 5.7 |
| Non-rejectors (Alemtuzumab) | 9 | 0 | 11.1 | 88.9 |
| Non-rejectors (Rituximab) | 18 | 0 | 50.0 | 50.0 |
| External validation patients (EMPIRIKAL trial) | ||||
| Rejectors (TCMR + Mixed) | 9 | N/A | ||
| Non-rejectors (External) | 15 | N/A | ||
Percent of patients assigned to each immunological risk level per group within the cohorts. As per local centre protocol patients deemed to be of Low immunological risk were: recipients without HLA antibodies or recipients receiving a first transplant kidney from a HLA identical sibling. Standard immunological risk: recipients with HLA antibodies; and the following groups (regardless of presence or absence of HLA antibodies): Husband to Wife, Child to Mother, Second or subsequent kidney transplant, Black recipient. High immunological risk: recipients who are cross match negative by flow-cytometry but who have a current or historic antibody which is directed against the new organ, and has arisen following exposure to this antigen from a previous solid organ transplant or pregnancy. Recipients who are cross-match positive by flow-cytometry are deemed HLA Antibody Incompatible (HLAi) and receive Alemtuzumab (Campath®) induction and may also undergo pre-operative antibody removal.
The induction agent for patients in the KALIBRE study was Basiliximab, unless otherwise specified. Patients in the EMPIRIKAL study all received induction with Basiliximab, and 2/3 of the donor grafts would have been treated with an experimental complement inhibitor right before transplantation (unblinding had not been available at the time of submission).