The first participants in a new clinical trial for a potential chronic kidney disease (CKD) treatment have been recruited at Oxford University Hospitals (OUH).
The trial, named EASi-KIDNEY, will assess whether the new treatment, vicadrostat (also known as BI 690517), can improve outcomes for CKD patients when combined with existing treatments.
The trial will take place in 15 to 20 countries, with around 11,000 expected participants.
Patrick Wallace, one of the first to join the trial at the Oxford Kidney Unit at OUH, said: "I wanted to participate in the trial as I am conscious of the vital importance of clinical trials in improving our knowledge of conditions such as chronic kidney disease.
"It is important to me to contribute towards providing robust evidence for new treatments even if vicadrostat (BI 690517) won't be available to people outside the trial for several years."
CKD is a progressive condition that can lead to 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.
The trial will investigate whether the combination of vicadrostat and the existing treatment, empagliflozin, reduces the risk of kidney disease progression, hospitalisation for heart failure, or death from cardiovascular disease in people with CKD.
William Herrington, professor of clinical trials and epidemiology of kidney disease at Oxford Population Health and chief investigator for EASi-KIDNEY, said: "It is estimated that there are about 850 million people around the world living with chronic kidney disease, which currently has no cure.
"Additional treatments are urgently required to lessen the often devastating impact of kidney failure on quality of life and reduce the risk of cardiovascular disease and premature death."
The new compound, vicadrostat, has been developed by Boehringer Ingelheim, who are sponsoring the trial.
It was tested in an earlier phase II trial, which showed promising results.
Dr Ioannis Sapountzis, head of global therapeutic areas at Boehringer Ingelheim, said: "We are tremendously encouraged by the promising results of our previous trial.
"By advancing into a global phase III trial programme, we're taking a crucial step forward in chronic kidney disease care."
Adults with CKD who are eligible to participate in the trial will be contacted by their family doctor or hospital consultant.
Participants are asked to stay in the study for three to four years.
It is hoped that full results will be available in 2028 or 2029.
The trial will be the first to use the new clinical trial management platform developed by Protas, called 'Cantata'.
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