OUH recruits 100th patient on major international kidney trial

The hundredth Oxford University Hospitals (OUH) patient has been recruited to a major international clinical trial investigating whether a potential new treatment can help slow the progression of chronic kidney disease (CKD) and reduce cardiovascular events.

The EASi-KIDNEY™ trial is evaluating whether the drug vicadrostat/empagliflozin improves clinical outcomes in people living with CKD.

The trial is running in 20 countries and is aiming to recruit around 11,000 people. Currently, OUH’s Churchill Hospital, which recruited its first participant in August 2024, is the trial’s second highest recruiting site globally. 

The Local Lead Investigator for EASi-KIDNEY in Oxford, Consultant Nephrologist Dr Ben Storey, said: “Oxford is making a substantial contribution to the recruitment efforts for this trial. We are delighted we have reached this milestone and to be playing such a key role in global kidney research. It reflects the strong collaborative efforts between our research and clinical teams, but also, the enthusiasm among our patients to take part.”

CKD is often a progressive condition that can lead to the need for kidney dialysis or a transplant and increases the risk of cardiovascular disease. It affects about one in 10 adults worldwide and is a leading cause of death globally.

A previous CKD trial, called EMPA-KIDNEY, led by researchers at Oxford Population Health, demonstrated that another drug, empagliflozin, reduced the risk of kidney disease progression or death from cardiovascular disease by 28% in patients with CKD with and without diabetes. 

Although empagliflozin is now recommended as a treatment for CKD in many countries, there are many people with CKD who still experience worsening disease and an increased risk of cardiovascular events.

The EASi-KIDNEY trial is looking at whether vicadrostat/empagliflozin reduces the risk of kidney disease progression, hospitalisation for heart failure or death from cardiovascular disease in people with CKD compared with empagliflozin, when added on top of standard medical care.

Half the participants are randomly allocated to receive vicadrostat/empagliflozin, while the other half will be randomly allocated a placebo.

This investigational therapy brings together empagliflozin, a well established treatment for chronic kidney disease, and vicadrostat, which inhibits aldosterone synthesis—an additional pathway believed to contribute to kidney and cardiovascular damage. Vicadrostat/empagliflozin showed promising results in an earlier Phase II study and is being developed by Boehringer Ingelheim, the sponsor of the trial.

Dr Parminder Judge, Associate Professor at Oxford Population Health, Honorary Consultant Nephrologist in OUH, and Co-Principal Investigator, said: "We saw very promising results from the earlier Phase II trial of this new treatment. We hope that this pivotal trial – which will be one of the largest trials ever conducted in this population - will have equally encouraging findings and lead to real clinical improvements for people living with CKD. 

“We’re extremely grateful to the participants, the local site staff, regional coordinating centre staff, and all members of EASi-KIDNEY committees, without whom this would not be possible.”