FDA Approves Kerendia for Adults With Type 1 Diabetes and Chronic Kidney Disease
The U.S. Food and Drug Administration (FDA) has approved Kerendia (finerenone) for adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). The new indication allows Kerendia to be used to reduce urinary albumin-to-creatinine ratio (UACR), a marker of kidney damage that is associated with the progression of chronic kidney disease.
The approval expands the role of finerenone, a non-steroidal mineralocorticoid receptor antagonist, in kidney and cardiovascular disease. Kerendia was previously approved for certain adults with CKD associated with type 2 diabetes and for adults with heart failure and a left ventricular ejection fraction of at least 40%.
According to Bayer, the manufacturer of Kerendia, the new approval addresses a long-standing treatment gap for people with T1D and CKD. The FDA decision followed a Priority Review of the company's supplemental New Drug Application.
What Is Kerendia?
Kerendia contains finerenone, which blocks overactivation of the mineralocorticoid receptor. This receptor is involved in processes affecting the heart and kidneys.
In people with certain forms of chronic kidney disease, excessive mineralocorticoid receptor activity may contribute to inflammation and fibrosis. Finerenone is designed to interfere with this pathway.
The medication is taken orally once daily. The newly expanded indication applies specifically to adults with CKD associated with type 1 diabetes.
Importantly, the FDA indication for T1D-associated CKD focuses on reducing UACR. The expectation is that lowering UACR may help reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR) and end-stage kidney disease.
Evidence From the FINE-ONE Trial
The FDA decision was supported by results from the Phase III FINE-ONE trial, which evaluated finerenone in adults with type 1 diabetes and chronic kidney disease.
The randomized, double-blind, placebo-controlled study enrolled 242 adults. Participants had CKD, albuminuria and an eGFR between 25 and less than 90 mL/min/1.73 m². They were receiving treatment with an ACE inhibitor or angiotensin receptor blocker and were randomly assigned to finerenone or placebo.
The primary outcome was the change in UACR over six months.
Published results showed that UACR decreased more substantially among participants receiving finerenone than among those receiving placebo. At six months, UACR decreased by approximately 34% from baseline with finerenone, compared with approximately 12% with placebo. The difference corresponded to a 25% greater reduction with finerenone compared with placebo.
The study also found a change in eGFR during treatment. At six months, the average change was approximately -5.6 mL/min/1.73 m² with finerenone and -2.7 mL/min/1.73 m² with placebo. The researchers noted that eGFR values moved toward baseline during the washout period.
These findings were published in the New England Journal of Medicine in March 2026.
What Does UACR Tell Us?
Urinary albumin-to-creatinine ratio measures the amount of albumin in urine relative to creatinine. Elevated urinary albumin can indicate damage to the kidney's filtering system.
Monitoring UACR is therefore an important part of assessing kidney health, particularly in people with diabetes.
The FINE-ONE trial was designed primarily to measure the effect of finerenone on UACR rather than to directly establish a long-term reduction in kidney failure events. The FDA indication consequently describes the reduction in UACR and states that this reduction is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease.
That distinction is important when interpreting the research. A reduction in a biomarker such as UACR is not identical to directly demonstrating fewer cases of kidney failure in a clinical trial.
Hyperkalemia Is an Important Safety Consideration
Finerenone can increase blood potassium levels, a condition known as hyperkalemia.
In the FINE-ONE study, hyperkalemia occurred in 10.1% of participants receiving finerenone compared with 3.3% of those receiving placebo. Two participants, or 1.7% of the finerenone group, discontinued treatment because of hyperkalemia.
Because of this risk, potassium and kidney function need to be assessed before treatment and monitored during therapy. The FDA prescribing information includes specific recommendations for dosing and monitoring based on serum potassium and eGFR.
Kerendia is contraindicated in people taking strong CYP3A4 inhibitors and in patients with adrenal insufficiency. The prescribing information also contains warnings concerning drug interactions and kidney function.
Patients should not start, stop or change finerenone without discussing treatment with their healthcare professional.
Kerendia's Other Approved Uses
The new T1D indication adds to several existing uses for finerenone.
For adults with CKD associated with type 2 diabetes, Kerendia is approved to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure.
Kerendia is also approved for adults with heart failure and a left ventricular ejection fraction of at least 40%. In that setting, the drug is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits.
These indications are based on different clinical evidence and should not be considered interchangeable.
What the New Approval Means
For adults living with both type 1 diabetes and chronic kidney disease, the approval provides another treatment option specifically addressing kidney disease associated with T1D.
The clinical evidence demonstrates a significant reduction in UACR compared with placebo over six months. However, longer-term outcomes remain important when considering how changes in UACR translate into individual risks of kidney failure and other complications.
The broader finerenone research program continues to examine kidney and cardiovascular outcomes in different patient populations. For example, the FIDELIO-DKD and FIGARO-DKD trials studied people with CKD associated with type 2 diabetes, while other research has examined finerenone in populations without diabetes.
A June 2026 correspondence in the New England Journal of Medicine also highlighted an important limitation of the FINE-ONE study: participants were not receiving SGLT2 inhibitors or GLP-1 receptor agonists, making it difficult to determine the incremental benefit of finerenone alongside those contemporary therapies.
For that reason, clinicians will need to consider the full clinical picture, including kidney function, potassium levels, existing medications, cardiovascular risk and other individual factors.
The Bottom Line
The FDA's September 2026 approval expands the use of finerenone to adults with CKD associated with type 1 diabetes.
The FINE-ONE trial found that finerenone produced a greater reduction in UACR than placebo over six months. At the same time, hyperkalemia occurred more frequently with finerenone, reinforcing the importance of appropriate laboratory monitoring.
The approval represents an expansion of available treatment options for a population with significant kidney disease risk. It does not mean that finerenone is appropriate for every person with type 1 diabetes or CKD. Treatment decisions should be individualized and made with a qualified healthcare professional.
Sources
- U.S. Food and Drug Administration. Kerendia (finerenone) Prescribing Information, 2026.
- Heerspink HJL, Birkenfeld AL, Cherney DZI, et al. Finerenone in Type 1 Diabetes and Chronic Kidney Disease. New England Journal of Medicine. 2026;394:947-957.
- Heerspink HJL, et al. Finerenone in Persons with Chronic Kidney Disease without Diabetes. New England Journal of Medicine. 2026;395:533-545.
Medical disclaimer: This article is intended for general educational and informational purposes only. It is not medical advice, does not replace consultation with a physician or other qualified healthcare professional, and should not be used to diagnose, treat, cure or prevent any disease. Medication indications, dosing recommendations, contraindications and safety information can change. Always consult the current FDA prescribing information and your healthcare professional before starting, stopping or changing a medication.