On Thursday, the FDA approved finerenone (Kerendia) for adults suffering from chronic kidney disease (CKD) associated with type 1 diabetes. This marks the introduction of the first new treatment option for this specific population in over 30 years.
This selective non-steroidal mineralocorticoid receptor antagonist is designed to lower the urinary albumin-to-creatinine ratio (UACR). Reducing UACR is critical as it helps decrease the risk of sustained decline in estimated glomerular filtration rate (eGFR) and the onset of end-stage kidney disease.
Overactive mineralocorticoid receptors can lead to kidney disease progression and heart damage through various mechanisms including inflammatory, fibrotic, metabolic, and hemodynamic pathways.
Dr. Janet McGill from Washington University School of Medicine emphasized, “For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression. The approval of Kerendia to reduce UACR delivers an important new treatment option for a community with substantial unmet needs.”
Despite the availability of standard treatments aimed at glucose and blood pressure control, nearly 30% of adults with type 1 diabetes still develop CKD. This significantly elevates their risk for heart complications and kidney failure, making CKD a leading cause of mortality among this population.
The FDA’s approval of finerenone was supported by results from the phase III FINE-ONE study, which showed that the medication, in conjunction with standard care, led to a 22% reduction in UACR at three months and a 28% reduction at six months compared to placebo.
Furthermore, 68.1% of patients on finerenone achieved at least a 30% reduction in UACR, in contrast to 46.6% of those receiving a placebo. The American Diabetes Association regards this 30% reduction as a critical threshold for slowing CKD progression.
Finerenone’s safety profile for type 1 diabetes largely mirrors findings from studies involving type 2 diabetes-associated CKD, for which the drug was originally approved in 2021. It later received additional indications for treating symptomatic chronic heart failure.
Common adverse reactions (reported in 1% or more of patients) linked to finerenone include hyperkalemia, hypotension, and hyponatremia. The prescribing information advises caution regarding potential worsening of renal function in patients with heart failure. Contraindications for its use include adrenal insufficiency, concurrent use of strong CYP3A4 inhibitors, and hypersensitivity to any of its components.
Disclaimer: This summary is for informational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
Fuente: https://www.medpagetoday.com/nephrology/type1diabetes/123038
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