Nuffield Department of Population Health, University of Oxford

ILD88

Empagliflozin is a medication used to treat type 2 diabetes by helping the kidneys remove sugar from the blood. The EMPA-KIDNEY trial consisted of 6000 participants with chronic kidney disease (CKD), with or without type 2 diabetes. At least 1000 of these were recruited from the UK. The participants were randomised to empagliflozin 10mg once daily or a matching placebo. Post-trial studies allowed assessment of the impacts of empagliflozin on patients with CKD and has suggested that intensive glucose-lowering may have a long-term benefit on the risk of reaching end stage kidney disease (ESKD). We would like to use UK Renal Registry (UKRR) data to follow up on the EMPA-KIDNEY trial for several years after the trial period ends, at least until the end of 2025. During this time, participants will not be issued with any study treatment. This would provide valuable information on the longer-term effects of empagliflozin in people with CKD. We will assess outcomes of kidney disease progression through UKRR data on date of starting dialysis or receiving transplantation. We will also look at data on cardiovascular death. Long-term data from EMPA-KIDNEY would be particularly invaluable for health-economic assessments, as dialysis and kidney transplantation are expensive and empagliflozin has the potential to substantially delay and perhaps even prevent development of ESKD, as well as reduce death. Follow-up through the UKRR would reduce the burden on local clinical teams reporting data and reduce any need for follow-up of participants directly.

16/03/2021