Rationale and design of a randomised phase III registration trial investigating finerenone in participants with type 1 diabetes and chronic kidney disease: The FINE-ONE trial

PLS Type 1 diabetes is a condition where people have high blood sugar due to insufficient production of a protein called insulin. People with type 1 diabetes can often develop kidney disease. Eventually, their kidneys may stop working, resulting in the need for a procedure called dialysis which removes waste products from the body. In addition, people with type 1 diabetes and kidney disease are at higher risk of heart disease and tend to have a shorter life expectancy than people with type 1 diabetes without kidney disease. Here, the authors describe the design of a study in people with type 1 diabetes with kidney disease, called FINE-ONE. FINE-ONE is studying whether a drug called finerenone can slow down the progression of kidney disease. The FINE-ONE study will look at whether finerenone will reduce the amount of a protein called albumin in the urine. A high level of albumin in the urine is commonly recognized to be a sign of kidney disease. Reducing the amount of urine albumin with finerenone would show that finerenone can protect the kidneys of people with type 1 diabetes with kidney disease. If the study is successful, finerenone could be the first drug for kidney protection available to patients with type 1 diabetes in 30 years. Finerenone is already approved for the treatment of patients with type 2 diabetes and kidney disease. [Display omitted] •Finerenone is indicated for the treatment of chronic kidney disease (CKD) in type 2 diabetes.•The FINE-ONE clinical trial is investigating the effect of finerenone in people with type 1 diabetes and CKD.•The trial is investigating change in albuminuria from baseline over 6 months.•Albuminuria will be used as a bridging biomarker for regulatory approval purposes in type 1 diabetes and CKD.•Finerenone could become a new registered treatment for CKD progression in type 1 diabetes. Despite guideline-recommended treatments, including renin angiotensin system inhibition, up to 40 % of individuals with type 1 diabetes develop chronic kidney disease (CKD) putting them at risk of kidney failure. Finerenone is approved to reduce the risk of kidney failure in individuals with type 2 diabetes. We postulate that finerenone will demonstrate benefits on kidney outcomes in people with type 1 diabetes. FINE-ONE (NCT05901831) is a randomised, placebo-controlled, double-blind phase III trial of 7.5 months’ duration in ∼220 adults with type 1 diabetes, urine albumin/creatinine ratio (UACR) of ≥ 200–< 5000 mg/g (≥ 22.6–< 565 m