A large international study has found that the kidney disease drug Filenone may benefit far more patients than current treatment guidelines recommend.
Researchers reported that the drug helps protect kidney function, lower the risk of cardiovascular complications, and improve survival for patients with chronic kidney disease (CKD). This effect was seen not only in diabetic patients but also in patients with non-diabetic CKD and certain glomerular diseases.
The findings were presented at the European Society of Nephrology Congress in Glasgow, UK, and simultaneously published in three major medical journals: lancet, New England Medical Journaland Japan Automobile Manufacturers Association. Achieving publication in all three journals simultaneously is an unusual milestone in clinical research.
Finerenone shows promise beyond diabetes
Finerenone is a nonsteroidal mineralocorticoid receptor antagonist currently approved for the treatment of CKD associated with type 2 diabetes. Overactivation of mineralocorticoid receptors contributes to inflammation and scarring in many kidney diseases, so researchers are increasingly interested in whether the drug can help patients with a wider range of kidney diseases.
To investigate this possibility, scientists at the George Institute for Global Health have begun a series of studies examining finerenone in populations outside of its current approval.
FIND-CKD study slowed decline in kidney function
The FIND-CKD trial, led by Professor Hid Hairpink of the George Institute and Professor Vlad Perković of UNSW Sydney, enrolled 1,584 people with non-diabetic CKD from 24 countries.
Patients who received finerenone in addition to standard therapy had a significantly slower decline in kidney function than those who received standard therapy alone. The study also found that finerenone reduced the combined risk of kidney failure, worsening of CKD, heart failure, and cardiovascular death by 23%.
The results of the FIND-CKD study are New England Medical Journal.
Benefits seen in glomerular diseases
The second analysis was led by George Institute Associate Professor Brendon Noyen. Japan Automobile Manufacturers Associationfocused on participants with glomerular disease. These conditions involve immune-related damage to the kidney’s filtration unit and often have limited treatment options.
In these patients, Filenone reduced the risk of kidney failure or CKD progression by 26% compared to placebo. The drug also reduced albuminuria, a measure of protein in the urine and a key sign of kidney damage, by 42% after 12 months.
Reduced kidney failure, heart risk, and death
In a third study published in lancetResearchers combined data from the FIND-CKD trial with two earlier phase III studies in patients with diabetic CKD.
The pooled analysis included 14,574 participants with both diabetic and non-diabetic chronic kidney disease. Compared to placebo, finerenone reduced the risk of kidney failure or disease progression by 24%.
The drug also lowered the risk of hospitalization for heart failure or cardiovascular death by 20% and the risk of death from any cause by 12%.
The researchers reported that these benefits were consistent regardless of whether the patient had diabetes, type of kidney disease, or level of kidney function.
Associate Professor Brendon Nguyen, Head of Global Clinical Trials at the George Institute, said the study results supported finerenone as a cornerstone therapy for CKD.
“Diabetes is the single most common cause of chronic kidney disease worldwide, but most people living with CKD do not have diabetes and there are currently few effective treatment options. It is important to address this unmet need because improving outcomes in non-diabetic CKD has the potential to significantly reduce the global burden of kidney disease.”
potentially impacting millions of people
In all three studies, finerenone was generally well tolerated. Increased blood potassium levels (hyperkalemia) occurred more frequently in patients receiving the drug than in patients receiving a placebo. However, treatment discontinuation and hospitalization related to hyperkalemia were rare.
Chronic kidney disease affects 1 in 10 people worldwide, or approximately 850 million people. Already a leading cause of illness and death, CKD is predicted to become the fifth leading cause of premature death worldwide by 2040.
As the disease progresses, the risk of hospitalization, cardiovascular complications, and death rapidly increases, making early and effective treatment increasingly important.
“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 in millions of people around the world,” said Professor A/Neuen.
