EVITRA Study
Research type
Research Study
Full title
Study to compare once-daily Extended Release Tacrolimus Versus twice-daily Immediate Release Tacrolimus following renal allograft failure to Reduce the risk of Allosensitisation
IRAS ID
241759
Contact name
Michelle Willicombe
Contact email
Sponsor organisation
Imperial College London
Eudract number
2018-000652-18
Duration of Study in the UK
4 years, 11 months, 27 days
Research summary
There is no evidence on how to appropriately manage the anti-rejection medications in kidney transplant patients once their transplant has failed and they return to dialysis (kidney replacement therapy). Current options are usually doctor lead, and include transplant removal, or more commonly, leaving the transplant in-situ, with or without remaining on anti-rejection treatment. The management is likely to depend on the suitability of the patient to receive another transplant, as such patients will benefit from the treatment which is less likely to reduce in the development of new ‘HLA’ antibodies. HLA antibodies are antibodies which are detectable in the blood of people if they are exposed to another person’s HLA proteins, this is usually following pregnancies, blood transfusions or transplantation. The presence of HLA antibodies in kidney patients with ESKD makes it more difficult to find an appropriately compatible kidney transplant, and these patients often have to wait much longer for a transplant and some die whilst waiting.
The aim of this study is to prospectively monitor patients with failed transplants on dialysis who are awaiting a further kidney transplant. The study will compare two different preparations of tacrolimus, an anti-rejection tablet. Half of the patients will take once-daily extended release tacrolimus and the other half will take twice-daily immediate release tacrolimus. Both medications are licensed and used to prevent rejection. The study aims to compare the rate of new HLA antibodies in both groups, along with determining quality of life and adherence by means of questionnaires. The hypothesis is that a simpler anti-rejection treatment regimen may improve adherence, target levels of medication in the blood and reduce the formation of antibodies. The study will take place in kidney dialysis units in the UK and all study procedures will coincide with dialysis sessions, avoiding additional hospital visits for patients.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/1199
Date of REC Opinion
27 Jul 2018
REC opinion
Favourable Opinion