FDA Approves Kerendia for Adults With Type 1 Diabetes and Kidney Disease

What Is Kerendia and How Does It Work?

The FDA has approved Kerendia (finerenone) for adults who have chronic kidney disease (CKD) linked to type 1 diabetes.

CKD is a condition where the kidneys slowly lose their ability to filter waste from the blood.

About 30% of adults with type 1 diabetes in the United States develop kidney disease.

Kerendia belongs to a class of medicines called mineralocorticoid receptor antagonists. It works by blocking certain proteins in the body that cause inflammation and tissue scarring in the kidneys. By blocking these harmful effects, Kerendia helps lower protein levels in the urine. Lowering urine protein helps protect kidney function over time. This is expected to slow down kidney damage and lower the risk of kidney failure. Since 2021, this medicine has also been approved for adults with CKD linked to a different type of diabetes (type 2 diabetes).

Why Was Kerendia Approved?

The approval was based on a clinical trial called the FINE-ONE study. The study included 242 adults with type 1 diabetes and CKD. Participants were randomly assigned to take either Kerendia or an inactive pill called a placebo once daily, alongside their usual insulin regimen and blood pressure treatments.

Researchers measured the levels of protein in each person’s urine over six months. High protein in the urine is a primary sign of kidney damage. Over six months, people taking Kerendia had their urine protein levels decrease by about 25% more than those taking placebo. More people taking the medicine also had a meaningful drop in their urine protein levels than people taking placebo.Lowering urine protein is a key milestone that indicates a lower risk of future kidney failure. Larger studies in people with a different type of diabetes (type 2) have shown that the lower urine protein levels seen with Kerendia are connected to long-term kidney benefits.The side effects seen in the FINE-ONE trial were consistent with previous studies in adults with type 2 diabetes. The most common side effects included high potassium levels, low blood pressure, and low sodium levels.

What Should You Know Before Taking It?

Kerendia is an oral tablet taken once a day. You can take it with or without food. If you have trouble swallowing whole tablets, you can crush the tablet and mix it with water or soft food like applesauce right before taking it.

Kerendia can cause high potassium levels. Your healthcare provider will perform blood tests to check your kidney function and potassium levels before you start treatment and during your treatment. High potassium can be dangerous, so your healthcare provider may adjust or pause your treatment if your levels get too high. Always speak with your healthcare provider before taking potassium supplements or using salt substitutes that contain potassium.Avoid eating grapefruit or drinking grapefruit juice while taking Kerendia. Grapefruit can increase the amount of medicine in your body and raise your risk of side effects. Be sure to tell your healthcare provider about all prescription drugs, over-the-counter medicines, and supplements you take. Some medicines can cause serious interactions with Kerendia.Before starting this medicine, let your healthcare provider know if you are pregnant or planning to become pregnant. If you are breastfeeding, you should not breastfeed while taking Kerendia and for one day after your last dose.