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.
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.
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.
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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