BioPAsSPoRT: Biomarkers for Patient Assessment and Stratification Post Renal Transplant

Chronic kidney disease affects approximately 10% of the global population and the incidence is increasing annually with the rise in comorbidities. 2-4% of patients with chronic kidney disease are expected to progress to end stage kidney disease requiring renal replacement therapy in the form of dialysis or transplantation. Transplantation is the optimum treatment for end stage kidney disease both in terms of cost savings to the NHS and patient quality of life but organs are scarce. In order to expand the pool of available grafts, extended criteria donations are increasingly being used but these come with increased rates of complications such as delayed graft function. Currently delayed graft function is defined as the need for dialysis in the first week after transplant in the absence of hyperkalaemia. As there are no definitive guidelines on when it is necessary to dialyse a patient post-transplant, diagnosis of delayed graft function is therefore subjective to some extend and governed by the overseeing clinician. Using the innovative multiplexing biochip technology from Randox, BioPAsSPoRT aims to combine the novel Aminoacylase-1 biomarker with other established and potential renal biomarkers to develop an assay that will provide a method to predict the development of delayed graft function early post-renal transplant and provide prognostic information to allow risk-based patient follow-up stratification. An initial cohort of 241 patients was investigated and statistical analysis determined an optimal biomarker panel including ACY-1, sTNFR1, YKL-40 and cystatin C which was then manufactured into a prototype Renal Transplant Array to be validated in a multi-centre independent cohort of a further 320 patients. Statistical modelling determines that the renal transplant array shows promise with regards to early detection of delayed graft function and prognosis with regards to dialysis-free survival with a serum sample taken day 1-3 post-transplant. A further prospective clinical trial will be designed to assess the final array before commercial availability.