Phase III Clinical FINE-ONE Study Will Evaluate the Efficacy and Safety of Finerenone Versus Placebo in Slowing Disease Progression in Adult Patients with Type 1 Diabetes (T1D)-Related Chronic Kidney Disease (CKD).
Up to 40% of Type 1 Diabetes Patients Are Affected by Chronic Kidney Disease
One-quarter of patients with type 1 diabetes-related chronic kidney disease will progress to end-stage renal disease.
Patients with chronic kidney disease associated with type 1 diabetes have limited treatment options, and no new therapies have been approved for nearly 30 years.
Bayer Announces Initiation of FINE-ONE Study, a Global Multi-Center, Randomized, Placebo-Controlled, Double-Blind Parallel Group Phase III Clinical Trial Aimed at Evaluating the Efficacy and Safety of Finerenone Compared to Placebo in Adult Patients with Chronic Kidney Disease Associated with Type 1 Diabetes. The primary objective of this study is to demonstrate the superiority of finerenone over placebo in reducing the Urinary Albumin-to-Creatinine Ratio (UACR) within 6 months.
Finerenone has been approved in more than 70 countries worldwide for the treatment of chronic kidney disease associated with type 2 diabetes. Type 2 diabetes is primarily a chronic metabolic disorder, while type 1 diabetes is considered to be related to genetic and environmental factors, with the insulin-secreting cells in the pancreas being destroyed. Although type 1 diabetes typically occurs during childhood or adolescence, it can also develop in adults. Chronic kidney disease affects up to 40% of people with type 1 diabetes. The incidence of chronic kidney disease caused by type 1 diabetes increased by 58.2% from 1990 to 2007, and by 21.7% from 2007 to 2017.
"Beyond diabetes and hypertension management, there are currently very limited treatment options available to slow disease progression in patients with chronic kidney disease associated with type 1 diabetes," said Professor Janet McGill, a professor of medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University and co-chair of the Executive Committee for the study. "Despite advances in reducing risks for people with type 2 diabetes, research on chronic kidney disease associated with type 1 diabetes remains insufficient. There is a significant unmet need to reduce the risk of end-stage renal disease and cardiovascular events in this population. We need new strategies to slow the decline in kidney function, which is why this important study is a welcome development for both patients with chronic kidney disease related to type 1 diabetes and the clinical community."
The clinical characteristics of chronic kidney disease in patients with type 1 diabetes are increased albuminuria, which is the first sign of kidney damage, and may later progress to significant albuminuria and a decline in eGFR. Although guidelines recommend methods for controlling hyperglycemia, hypertension, and albuminuria in patients with type 1 diabetes, residual risk remains high, with up to one-quarter of patients progressing to end-stage renal disease. Chronic kidney disease is a leading cause of death in patients with type 1 diabetes.
"Despite the harm caused by long-term kidney complications in people with type 1 diabetes, there has been very little research into the high residual risk of disease progression among those with type 1 diabetes-related chronic kidney disease," said Dr. Sanjoy Dutta, Chief Scientific Officer of JDRF, the world's leading type 1 diabetes research organization. "We are pleased that Bayer is conducting a pivotal clinical study to evaluate the efficacy of finerenone in improving kidney outcomes for patients with chronic kidney disease associated with type 1 diabetes, with the aim of submitting the results to regulatory authorities for approval. JDRF is committed to collaborating with Bayer to help make this critical study a success."
Christian Rommel, PhD, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of Research and Development, said: "For nearly three decades, there has been no innovative treatment approved to address the high risk of kidney disease progression in adults with chronic kidney disease associated with type 1 diabetes. We are excited about the prospect of being able to help this population. Given that the underlying causes of chronic kidney disease in both types of diabetes are the same, albuminuria is closely linked to the progression of kidney disease, and there is substantial evidence showing the efficacy of finerenone in patients with chronic kidney disease associated with type 2 diabetes, we anticipate that finerenone will also reduce kidney disease progression in adult patients with chronic kidney disease associated with type 1 diabetes."
The study plans to enroll approximately 220 adults with type 1 diabetes-related chronic kidney disease (CKD) to compare finerenone with placebo on top of standard therapy. Patients will be randomized 1:1 to receive either finerenone or placebo, in addition to standard therapy including renin-angiotensin system (RAS) blockade therapies such as angiotensin-converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB). In the FINE-ONE study, whether finerenone can slow CKD progression will be demonstrated by reductions in albuminuria, with the primary endpoint being the change from baseline in the urine albumin-to-creatinine ratio (UACR) (ratio to baseline) over six months compared to placebo. UACR is planned as a biomarker to demonstrate delayed CKD progression. In the pre-specified FIDELITY pooled analysis of the pivotal Phase III FIDELIO-DKD and FIGARO-DKD studies conducted in patients with type 2 diabetes-related CKD, finerenone reduced the risk of CKD progression, fatal and non-fatal cardiovascular events, and showed a sustained reduction in UACR of more than 30% compared to placebo. Secondary endpoints of this study include evaluating the safety of finerenone, including the number of treatment-emergent adverse events (TEAEs), serious adverse events (TESAEs), and hyperkalemia (an adverse event of special interest).