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FDA Expands Kidney-Protecting Treatment Option to Type 1 Diabetes

Written by Ted Samson
Posted on October 6, 2026

The U.S. Food and Drug Administration (FDA) has expanded the approval of finerenone (Kerendia) to include adults with chronic kidney disease (CKD) related to type 1 diabetes (T1D). CKD is a common complication of type 1 diabetes. It is the first new treatment approved for people with T1D-related CKD in more than 30 years.

Finerenone lowers the amount of the protein albumin in the urine. In a clinical trial, people who took finerenone had a greater decrease in their urine albumin-to-creatinine ratio (UACR), a measure used to check for kidney damage, than those who took a placebo (inactive treatment). Higher levels of albumin in urine can be a sign of kidney damage.

Kerendia was first approved in 2021 for adults with CKD related to type 2 diabetes. The new approval means adults with T1D-related CKD now have another treatment option.

🗳️ Have you been screened for chronic kidney disease (CKD) while living with type 1 diabetes?
Yes, and screening showed signs of kidney disease.
Yes, and screening did not show signs of kidney disease.
No, but I’d consider getting screened.
No, and I’m not considering screening right now.

The FDA based the new approval on the reduction in UACR seen in the trial. The study didn’t directly show that Kerendia prevents kidney failure in people with T1D, but lowering UACR is expected to reduce the risk of kidney function getting worse over time.

What Is Kerendia and How Does It Work?

Finerenone is a type of medicine called a nonsteroidal mineralocorticoid receptor antagonist. It blocks mineralocorticoid receptors, which help control how the body handles salt and fluid. When overactivated, they can also contribute to inflammation and scarring in the kidneys.

Finerenone blocks these receptors. This may help reduce inflammation and scarring processes that contribute to kidney damage.

Finerenone doesn’t replace insulin. In the study that led to its approval, participants continued using insulin and an ACE inhibitor or ARB as part of their usual kidney treatment.

Kerendia is taken once daily as a tablet by mouth.

What Did the Study Find?

FINE-ONE, a phase 3 study, included 242 adults with T1D, CKD, and high levels of albumin in their urine. Participants continued taking insulin and an ACE inhibitor or angiotensin-receptor blocker (ARB) as part of their usual kidney treatment.

Participants received finerenone or a placebo for six months. Dosing was based on kidney function.

After six months, UACR decreased by 34 percent in people taking finerenone and by 12 percent in those taking the placebo. Overall, finerenone led to a 25 percent greater reduction in UACR compared with placebo.

What Should People Know About Safety?

The main safety concern with finerenone is hyperkalemia, which means having too much potassium in the blood. In FINE-ONE, hyperkalemia occurred in about 10 percent of people taking finerenone compared with about 3 percent taking placebo.

The prescribing information recommends checking blood potassium levels and kidney function before starting the treatment and checking potassium again four weeks after treatment begins.

Before starting any new treatment, make sure to ask your doctor about potential side effects and interactions with other medications.

What Does This Mean for People With T1D?

For people whose CKD is related to type 1 diabetes, the approval adds another treatment option aimed at protecting kidney health. It may be particularly relevant for people who still have high levels of albumin in their urine despite receiving standard kidney care.

Approaches to lowering UACR and protecting kidney function in people with T1D have focused largely on managing blood glucose and blood pressure and using ACE inhibitors or ARBs when appropriate. Finerenone works in a different way and can be added to this standard care for some adults with T1D and CKD.

At the same time, the evidence has an important limitation. The study showed that finerenone lowered a marker associated with kidney damage. It didn’t directly establish that finerenone prevents kidney failure or cardiovascular events in people with T1D.

If you have T1D and CKD, your diabetes or kidney care team can help you understand your treatment options based on your kidney function, other health conditions, and current medicines. Don’t start, stop, or change a treatment without talking with a healthcare professional.

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