FINE-START: Efficacy and Safety of Finerenone in Patients With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors

A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Participants With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors

Study to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.

FINE-START is a multicenter, international, randomized, placebo-controlled, double blind parallel-group Phase 3 study in adult participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors. The study will enroll adults (≥18 years) with CKD defined as eGFR ≥25 and <120 mL/min/1.73 m2, urinary albumin-to-creatinine ratio (UACR) ≥100 mg/g (11.3 mg/mmol) to <5000 mg/g (565 mg/mmol) and documentation of elevated albuminuria or proteinuria. A total of 180 participants will be included and randomized with equal allocation (1:1) to Finerenone or placebo. Finerenone or placebo will be administered once daily for approximately 6 months. Change in UACR from baseline over 6 months will be used as a primary endpoint to demonstrate slowing of kidney disease progression. The aim of this study is to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.

Main Inclusion Criteria:

1. Adults (≥18 years) with Chronic Kidney Disease defined as:

   • eGFR ≥25 and <120 mL/min/1.73 m2 using CKD-EPI 2009 formula at the Screening visit.
   • UACR ≥100 mg/g (11.3 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) and documentation of elevated albuminuria or proteinuria.

2. Potassium level ≤5.0 mmol/L at Screening (local assessment).

3. No current or previous (within 8 weeks prior to the Screening visit) treatment with RAS inhibition (ACEi, ARB, or Renin inhibitor (e.g. Aliskiren)).

Main Exclusion Criteria:

1. Participants with an HbA1c>11%.
2. Participants with type 1 diabetes.
3. Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.