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

Trials
Dominic StringerAnthony Dorling

Abstract

Chronic rejection is the single biggest cause of premature kidney graft failure. HLA antibodies (Ab) are an established prognostic biomarker for premature graft failure so there is a need to test whether treatment decisions based on the presence of the biomarker can alter prognosis. The Optimised TacrolimuS and MMF for HLA Antibodies after Renal Transplantation (OuTSMART) trial combines two elements. Firstly, testing whether a routine screening programme for HLA Ab in all kidney transplant recipients is useful by comparing blinding versus unblinding of HLA Ab status. Secondly, for those found to be HLA Ab+, testing whether the introduction of a standard optimisation treatment protocol can reduce graft failure rates. OuTSMART is a prospective, open-labelled, randomised biomarker-based strategy (hybrid) trial, with two arms stratified by biomarker (HLA Ab) status. The primary outcome was amended from graft failure rates at 3 years to time to graft failure to increase power and require fewer participants to be recruited. Length of follow-up subsequently is variable, with all participants followed up for at least 43 months up to a maximum of 89 months. The primary outcome will be analysed using Cox regression adjusting for stratifi...Continue Reading

References

Dec 1, 2004·Statistics in Medicine·Ian R White, Simon G Thompson
Feb 25, 2005·Transplantation·Christopher DudleyUNKNOWN Mycophenolate Mofetil Creeping Creatinine Study Group
May 9, 2014·Journal of Nuclear Cardiology : Official Publication of the American Society of Nuclear Cardiology·Brandon GeorgeInmaculada Aban

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Methods Mentioned

BETA
PCR

Software Mentioned

R
OuTSMART
Statistical Analysis Plan
Stata
East
MACRO
Cytel

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