Bayer Reports Broad CKD Benefits with Finerenone in INFINITY Analysis

Finerenone reduced the risk of kidney failure or major kidney function decline by 24% and lowered cardiovascular events by 20% across a broad chronic kidney disease (CKD) population, according to results from Bayer’s INFINITY pooled analysis presented at the European Renal Association (ERA) Congress 2026 and simultaneously published in The Lancet.

The findings extend evidence for finerenone beyond CKD associated with type 2 diabetes and support its potential use across a wider range of kidney diseases.

Broad Patient Population

The prespecified analysis combined data from three completed Phase III trials FIDELIO-DKD (NCT02540993), FIGARO-DKD (NCT02545049), and FIND-CKD (NCT05348733) and included 14,574 adults with diabetic and non-diabetic CKD. Over a median follow-up of three years, finerenone significantly reduced the risk of the primary composite kidney endpoint, defined as kidney failure or a sustained ≥57% decline in estimated glomerular filtration rate (eGFR), compared with placebo (HR 0.76; p<0.0001).

Kidney and Cardiovascular Outcomes

Finerenone lowered the risk of kidney failure alone by 15% (HR 0.85; p=0.03) and reduced the primary cardiovascular composite endpoint, hospitalization for heart failure or cardiovascular death by 20% (HR 0.80; p=0.0006).

The combined kidney–cardiovascular outcome was reduced by 23% (HR 0.77; p<0.0001). Exploratory analyses also suggested reductions in heart failure hospitalization, cardiovascular death, all-cause mortality, and progression to dialysis or kidney transplantation.

Consistent Benefits Across Subgroups

Treatment effects remained consistent across predefined subgroups, including patients with diabetic and non-diabetic CKD, varying levels of albuminuria, different stages of kidney impairment, and concomitant use of SGLT-2 inhibitors.

Brendon L. Neuen, lead global clinical trialist, emphasized that the consistency of benefits across diabetic and non-diabetic disease settings represents an important advance in efforts to protect patients from both kidney failure and cardiovascular complications.

Safety and Tolerability

Finerenone, a selective non-steroidal mineralocorticoid receptor antagonist (nsMRA), blocks mineralocorticoid receptor overactivation, a key driver of inflammation, fibrosis, kidney damage, and cardiovascular complications. The therapy’s tolerability profile remained favorable, with hyperkalemia incidence consistent with prior studies and no new safety signals observed.

Global Burden of CKD

CKD affects an estimated 850 million people worldwide and is the ninth leading cause of death, responsible for 1.5 million deaths annually, one every 20 seconds. Despite standard therapies, many patients continue to experience progressive kidney function loss, increasing risks of dialysis, transplantation, heart failure, and premature death.

Expanding Role of Finerenone

Christian Rommel, Global Head of Research and Development for Bayer’s Pharmaceuticals Division, said the findings reinforce the growing body of evidence supporting finerenone across high-risk CKD populations. He emphasized that results from more than 14,500 patients underscore the therapy’s potential to improve multiple kidney and cardiovascular outcomes regardless of the underlying cause of kidney disease.

FINEOVATE Program

The INFINITY analysis forms part of Bayer’s extensive FINEOVATE program, the largest nsMRA clinical program in CKD and heart failure. Ongoing studies are evaluating finerenone in pediatric CKD and additional cardiovascular indications, underscoring Bayer’s commitment to advancing kidney and heart health globally.

Reference

Finerenone significantly reduced the risk of kidney disease progression and cardiovascular outcomes in broad patient populations with CKD