• The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA^® (finerenone) in adults with chronic kidney disease (CKD) without diabetes who were also receiving background standard of care.
• More than 37 million adults in the U.S. have CKD, a progressive condition that can lead to cardiovascular complications and kidney failure.ⁱ An estimated 50% to 70% of people with CKD do not have diabetes,ⁱⁱ and among those who progress to end-stage kidney disease in the U.S., 63% do not have diabetes.ⁱ

Bayer announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for KERENDIA^® (finerenone), which is being investigated for the treatment of adults with chronic kidney disease (CKD) without diabetes who are receiving background standard of care.

Key Facts

• The sNDA was supported by results from the Phase III FIND-CKD trial investigating KERENDIA in adults with CKD without diabetes who were also receiving background standard of care.ⁱⁱⁱ
  • KERENDIA met the primary endpoint, showing a significant reduction in the rate of kidney function decline, as measured by estimated glomerular filtration rate (eGFR) slope (mean annual change from baseline to month 32), compared with placebo.
  • KERENDIA also showed a statistically significant reduction versus placebo in the risk of a secondary composite kidney-cardiovascular endpoint, which included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure or cardiovascular death.
• The safety profile of KERENDIA was consistent with prior Phase III studies. The incidence of serious adverse events was similar between the KERENDIA and placebo groups (20.9% and 21.2%, respectively).
• KERENDIA is approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes (T2D).^iv
• KERENDIA is also approved by the FDA to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with type 1 diabetes (T1D).^iv
• In addition, KERENDIA is approved by the FDA to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.^iv

What the sNDA Acceptance Means for Adults with CKD Without Diabetes

“As many as 70% of people with chronic kidney disease do not have diabetes, and even though this population is at high risk for progressive loss of kidney function and adverse cardiovascular outcomes, treatment advances have disproportionately centered on those people with chronic kidney disease and type 2 diabetes,”^ii,iii,v said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “If approved for this new indication, KERENDIA has the potential to help physicians slow kidney function decline and reduce the risk of kidney and cardiovascular complications.”

FIND-CKD Clinical Trial Designⁱⁱⁱ

FIND-CKD (NCT05047263) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III trial that investigated KERENDIA versus placebo in 1,584 adults with CKD without diabetes. Reflecting the diverse etiologies of CKD without diabetes, 56% of patients in the FIND-CKD trial who received KERENDIA had underlying glomerular disease, such as IgA nephropathy and focal segmental glomerulosclerosis, while 30% had hypertensive/ischemic nephropathy. Excluding type 2 diabetes, these are the two most common etiologies of CKD.^vi

Participants were randomized to receive either KERENDIA or placebo in addition to standard of care, which included maximally tolerated labeled doses of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB).

FIND-CKD Clinical Trial Resultsⁱⁱⁱ

• KERENDIA met the primary efficacy endpoint by showing a statistically significant improvement in eGFR slope compared with placebo.
  • The mean annual rate of eGFR decline from baseline to month 32 was −3.3 mL/min/1.73 m²/year with KERENDIA and −4.0 mL/min/1.73 m²/year with placebo, corresponding to a between-group difference of 0.7 mL/min/1.73 m²/year (95% CI, 0.3 to 1.1; p<0.001).
  • eGFR slope is a surrogate endpoint increasingly used to assess drug efficacy in CKD trials.
• As a key secondary endpoint, KERENDIA showed a statistically significant reduction in the risk of a prespecified composite kidney-cardiovascular outcome compared with placebo (hazard ratio 0.77; 95% CI, 0.60 to 0.99; p=0.04).
  • The composite outcome included kidney failure, sustained eGFR decrease ≥57%, hospitalization for heart failure, or cardiovascular death.
• 56% of patients in FIND-CKD who received KERENDIA had underlying glomerular disease, including IgAN and FSGS.
• The incidence rate of treatment-emergent adverse events (TEAEs) was 68.3% with KERENDIA and 65.4% with placebo. The rate of treatment-emergent serious adverse events (TESAEs) was 20.9% with KERENDIA and 21.2% with placebo. Hyperkalemia, an adverse event of special interest (AESI), was observed more frequently with KERENDIA (17%) compared to placebo (13.3%). The rate of serious hyperkalemia events and hyperkalemia leading to hospitalization or permanent discontinuation was ˂1% and ˂2%, respectively.

Detailed FIND-CKD trial results were published in the New England Journal of Medicine and presented at the 63rd European Renal Association (ERA) Congress.

KERENDIA’s Approved Indications^iv

Since 2021, KERENDIA has been approved to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with T2D.

In July 2025, KERENDIA received FDA approval to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.

In September 2026, KERENDIA was also approved by the FDA to reduce UACR, which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease in adults with CKD associated with T1D.