A groundbreaking Phase 3 clinical trial has demonstrated that finerenone, marketed as Kerendia by Bayer, significantly reduces kidney damage in patients with type 1 diabetes and chronic kidney disease. The results, presented at the American Society of Nephrology conference in Houston, mark the first therapeutic advancement for this patient population in over 30 years.
The FINE-ONE study, led by clinical pharmacologist Hiddo Lambers Heerspink of the University Medical Center Groningen, showed that finerenone reduced protein excretion in urine (albuminuria) by approximately 25% in 242 patients over six months. This reduction in proteinuria indicates decreased kidney damage and suggests the drug provides protective effects on kidney function.
Addressing a Critical Treatment Gap
Type 1 diabetes patients with kidney complications have been largely excluded from clinical trials due to safety concerns, leaving them with treatment options that date back more than three decades. Current management relies primarily on blood pressure-lowering drugs, specifically ACE inhibitors and ARBs, along with lifestyle modifications and blood sugar control.
"For people with type 1 diabetes and chronic kidney disease, treatment options have remained largely unchanged for over three decades," said Dr. Carolina Aldworth, Bayer's executive medical director. "The FINE-ONE results show the potential of Kerendia to address this unmet medical need."
While numerous therapeutic advances have emerged for type 2 diabetes kidney disease, patients with type 1 diabetes have been left behind. Heerspink noted that physicians often tell type 1 diabetes patients that treatments proven effective for type 2 diabetes cannot be used because their efficacy and safety haven't been rigorously evaluated in type 1 diabetes populations.
Study Design and Mechanism of Action
Finerenone works by blocking receptors for aldosterone, a hormone produced in the adrenal glands that regulates salt and water balance to maintain blood pressure. The drug had previously demonstrated positive effects in type 2 diabetes patients, slowing kidney function decline and providing cardiovascular protection.
The international study involved 82 hospitals across nine countries in Asia, Europe, and North America. Researchers chose protein loss in urine as the primary endpoint because previous research by Heerspink showed albuminuria serves as the best indicator of early, measurable kidney protection. Traditional endpoints like dialysis initiation and kidney transplantation occur too late in disease progression and would require impractically large, long-term studies in the smaller type 1 diabetes population.
Clinical Significance and Safety Profile
The drug was generally well-tolerated, with only slightly elevated potassium levels in the blood noted as a side effect. The reduction in proteinuria is expected to translate to decreased kidney failure rates in these patients, according to researchers.
Chronic kidney disease affects 30-40% of type 1 diabetes patients, putting them at increased risk of kidney failure and cardiovascular disease. Research indicates that more than one-third of patients with severe albuminuria develop kidney failure within 15 years of onset.
Growing Disease Burden
The study's importance is underscored by the increasing global burden of type 1 diabetes. The International Diabetes Federation Atlas reported that the disease affected approximately 9 million people globally last year, including more than 1.5 million children—a 13% increase from 2021's figure of 8.4 million. More than 500,000 new diagnoses were reported worldwide in the past year alone.
Type 1 diabetes is an autoimmune condition where the body attacks insulin-producing cells in the pancreas. Unlike type 2 diabetes, it requires insulin treatment and carries significant long-term complications, particularly progressive kidney function decline among patients who survive into middle and old age with modern insulin therapy.
Future Implications
Heerspink expressed optimism about the clinical impact: "We are very glad that the primary clinical trial endpoint has been met, as finerenone is already available for clinical use and we hope to be able to implement these findings in clinical practice very soon."
The results are expected to support finerenone's inclusion in treatment guidelines for type 1 diabetes, potentially offering the first new therapeutic option for kidney protection in this vulnerable patient population in three decades. The findings also encourage further research into new medications for type 1 diabetes patients at high risk of kidney and cardiovascular diseases.
