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

ABSTRACT:

Objectives

Development of pharmaceutical agents in transplantation is currently limited by long waits for hard endpoints. We applied a validated integrative risk-prognostication system integrative Box (iBox) as a surrogate endpoint to the TRANSFORM Study, a large randomised controlled trial, to project individual patient long-term kidney allograft survival from 1 year to 11 years after randomisation.

Design

Post-hoc analysis of a randomised open-label controlled trial.

Setting

Multicentre study including 186 centres in 42 countries worldwide.

Participants

2037 de novo kidney transplant recipients.

Intervention

Participants were randomised (1:1) to receive everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) or mycophenolic acid with standard

SUBMITTER: Aubert O 

PROVIDER: S-EPMC8499283 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature