University of Hertfordshire

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Description

ReMIND Clinical Trial:
This is a study designed to investigate the ability of Rituximab (a chemotherapy drug) to allow a reduction in maintenance immunosuppression in living donor renal transplantation. This is a five year randomised controlled trial (phase IV randomised, open label trial) that has already started in 2014. Again our role will be to undertake a series of interim analyses and also the formal end of trial analysis, potentially this trial is ongoing until August 2019.
The trial design is an open label, randomised, controlled trial of patients undergoing living donor renal transplantation. The patients will be randomised to either: 1) Rituximab plus standard care regimen and 1 week of steroid therapy or 2) Current standard care regimen. In order to allow for early stopping and monitoring of the study, Guy’s and St Thomas’s NHS Foundation Trust have employed a group sequential design with 9 interim analyses, each analysis occurring after recruitment of every 60 participants to the trial, a total of 600 patients to be recruited. The study design comprises stopping rules under the null hypothesis (inferiority), and under the alternative hypothesis (non-inferiority), with expected sample sizes of 299 under the null hypothesis, and 394 under the alternative, suggesting a high probability of early termination of the study. It is stated that it is expected that the sample size needed will be recruited by 31/11/2018. The primary trial outcome measure stated is improvement of eGFR at 1 year. Secondary trial outcomes are related to: biopsy proven acute rejection, graft and patient survival at 1 year,
Short titleReMIND
AcronymReMIND
StatusFinished
Period1/05/161/09/19

ID: 10149799