Extrait

Background and study aims Treatment of kidney disease accounts for a significant proportion of NHS spending. Transplantation is the best treatment for kidney failure, in terms of length and quality of life. It is also more cost-effective than dialysis. However, most transplants fail after 10-12 years and patients have to go back onto dialysis, placing a considerable burden on the NHS. Damage by the immune system, called 'chronic rejection' accounts for 50% of failing transplants and it is now possible to identify patients at risk by screening for a biomarker of chronic rejection called HLA antibodies (found in the blood). All transplant units in the UK can do this, but routine screening of patients has not been adopted because it is not clear how best to treat patients with antibodies. This study will test a screening and treatment protocol for HLA antibodies. The aim is to reduce transplant failure rates over 3 years. Who can participate? The trial is open to all kidney transplant recipients aged 18-70 years who have had their transplant for 12 months or more and currently have good kidney function. What does the study involve? Participants with antibodies will be randomly allocated to one of two groups: the biomarker-led (BLC) group or the standard care (SC) group. In the BLC group, test results are revealed and recruits will have their anti-rejection drugs changed to a regime of three drugs, prednisone, tacrolimus and MMF, each already licensed for use in transplant recipients. We have evidence that this treatment will be effective at preventing dysfunction and expect this to feed through to improvements in graft survival. In the SC group, screening results are not made available and participants will remain on their current treatments. Participants without antibodies will be randomly allocated to one of two groups: a group called blinded screening where results will not be given or a group called unblinded screening where results will be given. They will remain on standard treatment. Testing will continue every 8 months. Recruits in the SC group will move into the BLC group if they become antibody positive. What are the possible benefits and risks of participating? As well as the potential impact on transplant failure, the drugs used here are associated with better cholesterol profiles and lower blood pressures than others in common usage. There are potential risks. Tacrolimus is associated with an increased risk of diabetes mellitus and enhanced immunosuppression in general is associated with an increased incidence of infection, especially viral and with an increased risk of malignancy. It is difficult to predict such risks in this study. The incidence of diabetes, infection and malignancy will be monitored carefully on this trial. Where is the study run from? The study is run and coordinated by a team from King's College London, based at Guy's Hospital (UK). When is the study starting and how long is it expected to run for? Recruitment will begin in June 2013 and finish by May 2016. The study is scheduled to finish in May 2019. Who is funding the study? National Institute for Health Research through an EME programme grant (UK) Who is the main contact? Professor Anthony Dorling [email protected]

Critère d'inclusion

• Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal

Liens

• ictrp
• isrctn