Bayer’s Finerenone Delivers Positive Phase III Results in Non-Diabetic CKD

Share on Social Media

Am Bayer-Standort Basel sind der Hauptsitz der globalen Division Consumer Health und verschiedene Bereiche der Division Pharmaceuticals sowie der Schweizer Landesgesellschaft unter einem Dach vereint.  

At the Bayer location in Basel the Consumer Health Headquarters as well as different units of the Pharmaceuticals Division and the Swiss country operation are consolidated.
Bayer

Bayer’s Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline and reduces cardiorenal outcomes in non-diabetic CKD, supporting global regulatory submissions and expanding its potential beyond diabetes-associated disease.

Written By: Shaikh Yasmeen, PharmD

Reviewed By: Pharmacally Editorial Team

Bayer has reported positive results from the pivotal Phase III FIND-CKD trial (NCT05047263), presented as a late-breaking study at the European Renal Association (ERA) Congress 2026 and published in the New England Journal of Medicine. The study enrolled over 1,500 patients with non-diabetic chronic kidney disease (CKD) across diverse etiologies and showed that finerenone significantly slowed kidney function decline and reduced cardiovascular-kidney complications compared with placebo on top of standard care.

Primary Endpoint Achieved

The trial met its primary endpoint, demonstrating a statistically significant improvement in annualized estimated glomerular filtration rate (eGFR) slope. Patients on placebo experienced an annual decline of 4.0 mL/min/1.73 m² versus 3.3 mL/min/1.73 m² with finerenone, translating into a slower decline of 0.7 mL/min/1.73 m² per year (95% CI, 0.3–1.1; p<0.001). Exploratory analysis of the chronic eGFR slope showed an even greater benefit, with finerenone slowing kidney function loss by 1.24 mL/min/1.73 m² per year from Month 3 onward. Effects were consistent across prespecified subgroups representing multiple non-diabetic CKD causes.

Secondary Outcomes Reinforce Benefit

Finerenone reduced the composite risk of kidney failure, sustained ≥57% eGFR decline, heart failure hospitalization, or cardiovascular death by 23% versus placebo (HR 0.77; 95% CI, 0.60–0.99; p=0.04). Sustained reductions in albuminuria were observed, with a maximum 39% decrease in urine albumin-to-creatinine ratio at Month 12. The ≥57% threshold aligns with FDA guidance for CKD progression endpoints.

 Benefits Across Glomerular Disease Subtypes

A prespecified subgroup analysis, published in JAMA, focused on patients with glomerular diseases, including immunoglobulin A nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS), who comprised approximately 60% of the study population. Finerenone consistently slowed kidney function decline, reduced albuminuria by 42% at Month 12, and lowered the risk of kidney failure or sustained kidney function loss by 26% compared with placebo (HR 0.74; 95% CI, 0.57–0.97). Benefits were consistent regardless of disease subtype or baseline SGLT2 inhibitor use.

Safety Profile Remains Consistent

No new safety signals were identified. Overall adverse event rates were similar between groups. Hyperkalemia occurred more frequently with finerenone (17.0% vs. 13.3%), but serious events, hospitalizations, and discontinuations were uncommon, and no fatal cases were reported. Investigators emphasized hyperkalemia was manageable with routine monitoring, consistent with prior finerenone studies.

Expanding Beyond Diabetes-Associated CKD

Finerenone, a selective non-steroidal mineralocorticoid receptor antagonist (nsMRA), blocks receptor overactivation driving inflammation, fibrosis, kidney disease progression, and cardiovascular damage. Already approved in over 100 countries for CKD associated with type 2 diabetes and for heart failure with mildly reduced or preserved ejection fraction, FIND-CKD highlights its potential in non-diabetic CKD, which accounts for more than half of the estimated 850 million global cases.

Clinical Implications and Path Forward

Professor Hiddo Lambers Heerspink, co-chair of the study’s Executive Committee, noted that finerenone preserved kidney function and reduced cardiovascular-kidney outcomes across diverse etiologies. Bayer’s Global Head of R&D, Christian Rommel, emphasized the unmet need in non-diabetic CKD and the therapy’s broad applicability.

FIND-CKD is the largest Phase III study in non-diabetic CKD and the first to demonstrate consistent kidney and cardiovascular benefits of an nsMRA in this population. It marks the fifth positive Phase III program for finerenone. Bayer plans global regulatory submissions, potentially expanding the drug’s cardiorenal franchise beyond diabetes-associated CKD and offering a new option for a large underserved patient population.

Reference

Bayer’s finerenone significantly reduced kidney function decline and a composite of cardiovascular-kidney outcomes versus placebo in patients with non-diabetic chronic kidney disease

About the Writer

Shaikh Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.


Share on Social Media
Scroll to Top