Transplant Trial Watch

Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study.

Aubert, O., et al.

BMJ Open 2021; 11(10): e052138.


Aims
The aim of this study was to apply a validated integrative risk-prognostication system integrative Box (iBox) tool to predict long-term kidney graft survival in de novo kidney transplant recipients from the TRANSFORM Study.

Interventions
Patients in the TRANSFORM study were randomly assigned to receive either everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) or mycophenolic acid with standard-exposure CNI (MPA +sCNI).

Participants
2037 de novo kidney transplant recipients from the TRANSFORM study.

Outcomes
The main outcomes of interest were the projection of long-term death-censored graft survival and the comparison of the mean projected graft survival between the two treatment arms.

Follow-up
11 years post-transplantation.

CET Conclusions
This proof of concept study applied the iBox tool to predict long-term graft survival in the population from the TRANSFORM randomised controlled trial. The authors present proof-of-concept to predict survival to 11 years-post transplant using data collected from the study at 1 year, demonstrating long-term non-inferiority in graft survival. Clearly, this does not represent true validation of the iBox for this purpose, as there are no actual measured survival metrics for comparison. However, the iBox has been validated in other studies and shown to perform well across a variety of populations. It is, therefore, a very interesting approach to long-term outcome assessment for future studies.

Trial registration
ClinicalTrials.gov -NCT01950819

Funding source
Industry & non-industry funded