Previously, the FDA has approved Jardiance (empagliflozin) as a treatment option for adults with heart failure and to manage blood sugar in people ages 10+ with type 2 diabetes. More recently, in September 2023, the FDA approved Jardiance (10mg) for another treatment indication: chronic kidney disease (CKD) in adults. According to reporting from Shawn M. Carter in Healio, the approval follows the release of data from the Phase 3 EMPA-KIDNEY study.

This study sought to understand how Jardiance, an SGLT-2 inhibitor, impacted or halted CKD progression. In particular, researchers wanted to understand whether Jardiance could reduce the risk of cardiovascular death, hospitalization, end-stage kidney disease, and eGFR decline. “eGFR” refers to estimated glomerular filtration rate, a measure of how well your kidneys are functioning.

Altogether, 6,609 adults with CKD enrolled in the study. During the trial, participants were split into two groups. One group received Jardiance while the other was given a placebo. The trial’s primary outcome looked at how Jardiance affected eGFR decline, kidney or cardiovascular death, or disease progression. Results from the study show that Jardiance reduced the risk of eGFR decline or other complications by 28%, as well as significantly reduced the risk of hospitalization. While both groups experienced some adverse reactions, these were typically mild-to-moderate in scope. Results were also fairly consistent in people who had diabetes and those who did not.

Understanding Chronic Kidney Disease (CKD)

Also known as chronic kidney failure, chronic kidney disease is a condition characterized by the gradual and progressive loss of kidney function. Normally, your kidneys help to filter waste and excess fluids from your blood. These wastes and fluids are excreted when you urinate. When the kidneys become damaged, they can’t filter as well. As a result, these fluids and wastes accumulate in the body and cause a number of negative health effects. CKD may result from a number of different causes. These include glomerulonephritis or interstitial nephritis, diabetes, high blood pressure, urinary tract obstruction, vesicoureteral reflux, recurrent kidney infections, or polycystic kidney disease. To diagnose CKD, doctors may use clinical evaluation, patient history, and symptom identification before confirming the diagnosis through blood, urine, imaging, or kidney tissue testing. CKD may be managed with a variety of medications. If someone reaches end-stage kidney disease, they may require a kidney transplant or dialysis.

Symptoms associated with chronic kidney disease may include:

• Anemia (low red blood cell count)
• An enlarged liver and/or spleen
• Fatigue and general weakness
• Jaundice (yellowing of the skin, eyes, and mucous membranes)
• Vitamin deficiencies
• Appetite loss
• High blood pressure
• Dry, itchy skin
• Shortness of breath from fluid buildup in the lungs
• Weakened bones
• Changes in urination (urinating more or less than normal)
• Swollen feet and ankles
• Stunted growth
• Nausea
• Muscle cramping or twitching