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). It is the first new treatment approved for people with T1D-related CKD in more than 30 years.

Finerenone helps protect the kidneys by lowering 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.

The expanded approval applies specifically to adults with CKD associated with T1D. Kerendia was first approved in 2021 for adults with CKD related to type 2 diabetes.

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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 or reverses kidney disease in people with T1D. However, lowering UACR is expected to reduce the risk of kidney function getting worse over time.

What Did the Study Find?

The approval was based on FINE-ONE, a phase 3 clinical trial that included 242 adults with T1D, CKD, and high levels of albumin in their urine. Participants were also receiving insulin and a stable dose of an ACE inhibitor or ARB.

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

At six months, UACR had fallen by 34 percent among people taking finerenone and by 12 percent among those taking the placebo. The study’s primary analysis found a 25 percent reduction with finerenone compared with a placebo.

Lowering albumin in the urine is important because high levels are linked to a greater risk of CKD getting worse. However, FINE-ONE measured changes in UACR. It didn’t directly test whether finerenone prevents kidney failure.

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 CKD?

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 continue to have high levels of albumin in their urine despite standard kidney care.

Approaches to lowering UACR and slowing CKD progression in people with diabetes have included managing blood glucose and blood pressure and using ACE inhibitors or ARBs when appropriate. Finerenone works differently and can be added to standard care for some adults with T1D and CKD.

The evidence in T1D also has an important limitation. The clinical trial 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.

Your kidney care team can help you understand which treatments may be appropriate based on the cause and stage of your CKD, your kidney function, other health conditions, and your current medicines. Don’t start, stop, or change a treatment without talking with a healthcare professional.