METHOD OF PREDICTING WHETHER A KIDNEY TRANSPLANT RECIPIENT IS AT RISK OF HAVING ALLOGRAFT LOSS

摘要

Organ transplantation is currently recognised as the treatment of choice for patients with end-stage renal disease (ESRD), which is an underestimated but increasing burden worldwide. Despite the pressing need for improving patients risk stratification raised by transplant societies as well as regulatory agencies, no risk-stratification system exists that adequately predicts transplant patients' individual risk of allograft loss. This currently represents a limitation for improving patient management, as well as for defining early surrogate end points for clinical trials and development of pharmaceutical agents. The inventors now report the development and validation of an integrative risk prediction score to predict kidney allograft survival of individual patients (NCT03474003). The iBox risk prediction score is the first integrative system validated in several independent populations from Europe & North America as well as across 3 clinical trials (NCT01079143, EudraCT2007-003213-13, NCT01873157) covering distinct clinical scenarios. In particular, the advantages brought by the iBox risk prediction score are i) improved discrimination performance by combining traditional prognostic factors with mechanistically informed parameters, ii) outperformance when compared with currently existing scoring systems, iii) generalisability when assessed in geographically distinct cohorts from Europe and North America, iv) transportability at different times of evaluation post-transplant, v) performance in a variety of clinical scenarios including clinical trials and vi) readily accessible to clinicians and patients by an online tool for patient risk calculation. Thus, the present invention relates to a method of predicting whether a kidney transplant recipient is at risk of having allograft loss by implementing the iBox risk prediction score.