Major trials show finerenone preserves kidney function beyond diabetes

A series of major studies has shown that finerenone preserves kidney function, reduces cardiovascular risk, and improves survival across a much broader range of patients with chronic kidney disease (CKD) than it is currently recommended for. These benefits extend beyond diabetes to non-diabetic CKD and glomerular diseases.

The findings were presented today at the European Renal Association Congress in Glasgow, UK and simultaneously published in three of the world's leading medical journals The Lancet, The New England Journal of Medicine and JAMA – a rare achievement in clinical research.

Finerenone is a non-steroidal mineralocorticoid receptor antagonist currently approved for the treatment of CKD associated with type 2 diabetes. Overactivation of the mineralocorticoid receptor drives inflammation and fibrosis across many forms of kidney disease, prompting researchers at The George Institute for Global Health to evaluate its potential in a broader population of patients with CKD than currently indicated.

The FIND-CKD trial, led by The George Institute's Professor Hiddo Heerspink and UNSW Sydney's Professor Vlado Perkovic, assessed finerenone in 1,584 patients with non-diabetic CKD from 24 countries. When added to standard care, finerenone significantly slowed kidney function decline. The trial also showed that finerenone reduced the risk of kidney failure, CKD progression, heart failure, or cardiovascular death by 23%. These results were published in The New England Journal of Medicine.

A second study, led by The George Institute's Associate Professor Brendon Neuen and published in JAMA, focused on a subset of patients in the FIND-CKD trial who had glomerular diseases - a group of conditions characterised by immune-mediated kidney damage for which few treatment options are available. In these patients, finerenone reduced the risk of kidney failure or CKD progression by 26% compared with placebo and lowered albuminuria, or protein in the urine - a key marker of kidney damage - by 42% at 12 months.

In a third analysis, also led by A/Prof Neuen and published in The Lancet, researchers pooled data from FIND-CKD with two prior phase III trials in diabetic CKD. In this study of 14,574 patients with diabetic and non-diabetic CKD, finerenone reduced the risk of kidney failure or CKD progression by 24% versus placebo. Finerenone also reduced the risk of hospitalization for heart failure or cardiovascular death by 20%, and all-cause death by 12% versus placebo. These effects were consistent regardless of diabetes status, underlying kidney disease, or kidney function.

Associate Professor Brendon Neuen, Lead Global Clinical Trialist at The George Institute, said the findings support finerenone as a foundational therapy for CKD.

"Although diabetes is the single most common cause of chronic kidney disease worldwide, most people living with CKD do not have diabetes and currently have few effective treatment options. Addressing this unmet need is critical, as improving outcomes in non-diabetic CKD has the potential to substantially reduce the global burden of kidney disease."

Across all three studies, finerenone was generally well tolerated. Hyperkalaemia (high blood potassium levels) occurred more frequently with finerenone compared to placebo, but rates of treatment discontinuation and hospitalization due to hyperkalemia were low.

CKD affects around one in ten people globally, or approximately 850 million individuals. Already a leading cause of death and disability, it is projected to become the fifth largest contributor of premature death by 2040. Once CKD progresses to advanced stages, the risks of hospitalization, cardiovascular events, and death escalate dramatically, underscoring the urgency of early and effective intervention.

A/Prof Neuen said, "Taken together, these findings suggest that expanding the use of finerenone in patients with CKD has the potential to meaningfully reduce kidney failure and cardiovascular complications for millions of people worldwide."