BioPAsSPoRT - Biomarkers for patient assessment and stratification post-renal transplantation

Chronic kidney disease (CKD) affects 10-15% of the adult population. Progression to end stage kidney disease (ESKD) is a leading cause of morbidity and mortality worldwide with 2.6 million people receiving renal replacement therapy (dialysis or transplantation) in 2010. Numbers continue to increase markedly as a result of the global epidemics of type 2 diabetes and hypertension in particular which are linked with causing CKD. Kidney transplantation is the optimal treatment for ESKD with almost 80,000 transplants annually worldwide, with significantly better survival, major cost savings and quality of life compared with dialysis. Increasingly, to meet demand, kidneys are used from deceased donors after circulatory death and more marginal donors and overall ~80% of kidney transplants in the EU are from deceased donors. However, these have complications such as delayed graft function (DGF; when the transplanted kidney fails to work adequately in the first week following transplant) which affects 30-40% of patients and has a higher risk of mortality, transplant loss and increased hospital stay. Through an academic-industry-clinical partnership, we propose to manufacture and independently clinically validate a renal diagnostic. This post-transplant diagnostic is aimed at allowing earlier diagnosis of DGF and clinical intervention, risk stratification and tailoring of follow-up individually. This would result in major clinical and economic impact, ultimately prolonging transplant life and reducing the need for dialysis whilst improving patient empowerment and quality of life. A parallel health economic evaluation will enable the product to be optimally marketed to healthcare providers.