Bayer has announced the initiation of FINE-ONE, a global, multicentre, randomised, placebo-controlled, double-blind, parallel-group Phase III study to evaluate the efficacy and safety of a new investigational use of finerenone versus placebo in adults with chronic kidney disease (CKD) and type 1 diabetes. The primary objective of the study is to demonstrate efficacy of finerenone over placebo in reducing urine albumin to creatinine ratio (UACR) over 6 months.
Finerenone is marketed as Kerendia and approved for the treatment of adults with CKD associated with type 2 diabetes (T2D) in more than 70 countries worldwide, including the USA. CKD affects up to 40% of people with type 1 diabetes, states a Bayer press release, while “the prevalence of CKD due to type 1 diabetes increased by 58.2% from 1990 to 2007 and by 21.7% from 2007 to 2017”.
“Apart from diabetes and hypertension management, there are currently limited treatment options to slow kidney disease progression in people with CKD and type 1 diabetes,” said Janet McGill (Washington University, St Louis, USA) and co-chair of the study’s executive committee. “Despite progress in risk reduction in type 2 diabetes, CKD in type 1 diabetes remains understudied, leaving a huge unmet need for this population. New strategies are needed to slow their rate of decline in kidney function, which is why this important study comes as welcome news for people with CKD and type 1 diabetes and the clinical community alike.”
The press release goes on to detail that clinical course of CKD in people with type 1 diabetes is characterised by an increased urinary albumin excretion rate, which is the first sign of kidney damage and may progress to macroalbuminuria and decrease in estimated glomerular filtration rate (eGFR) in later stages. “Despite guideline-recommended therapies to control hyperglycaemia, hypertension, and albuminuria in patients with type 1 diabetes,” it adds, “residual risk remains high with up to a quarter progressing to end-stage kidney disease.”
“Despite the toll that long-term kidney complications take on people with type 1 diabetes, the research conducted to address the high residual risk of kidney disease progression in those living with type 1 diabetes and CKD is extremely scarce,” said Sanjoy Dutta, chief scientific officer of the Juvenile Diabetes Research Foundation (JDRF; London, UK). “JDRF is thrilled that Bayer is pursuing a pivotal clinical trial investigating finerenone in adults with CKD associated with type 1 diabetes with the goal of submission to regulatory agencies for consideration. JDRF is committed to collaborating to help this critical trial succeed.”
The planned study will investigate finerenone compared to placebo in addition to standard of care in approximately 220 adults with CKD and type 1 diabetes. Individuals will be randomized in a 1:1 ratio to receive either finerenone (10mg or 20mg once daily depending on their eGFR level) or placebo in addition to standard of care, consisting of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB).
The efficacy of finerenone in delaying kidney disease progression in the FINE-ONE study will be evaluated based on a reduction of albuminuria, with the primary endpoint being a change in UACR from baseline (ratio to baseline) over 6 months compared to placebo. UACR is planned to be used as a marker for the delay of kidney disease progression. Secondary endpoints will assess the safety of finerenone and include the number of individuals with treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs) and hyperkalaemia (adverse event of special interest).