Update to the study protocol, including statistical analysis plan, for the multicentre, randomised controlled OuTSMART trial: a combined screening/treatment programme to prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies.

Dominic StringerLeanne M GardnerJanet L PeacockIrene Rebollo-MesaRachel HiltonOlivia ShawRichard BakerBrendan ClarkRaj C ThuraisinghamMatthew BucklandMichael PictonJudith WorthingtonRichard BorrowsDavid BriggsSapna ShahKin Yee ShiuKeith McCulloughMysore PhanishJanet HegartyJohn StovesAimun AhmedWaqar AyubRobert HornePaul McCroneJoanna KellyCaroline MurphyAnthony Dorling

Published in: Trials (2019)

ISRCTN registry, ID: ISRCTN46157828 . Registered on 26 March 2013; EudraCT 2012-004308-36 . Registered on 10 December 2012.

Keyphrases

study protocol
randomized controlled trial
clinical trial
open label
double blind
placebo controlled
phase iii
phase ii
cross sectional
drug induced