Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (FIDELIO-DKD)

Bayer

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: Finerenone (BAY94-8862)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02540993

16244

2015-000990-11 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

Enrollment: 5,734 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women ≥18 years of age

• Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association

• Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:

  • persistent high albuminuria (UACR ≥30 to <300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) ≥25 but <60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
  • persistent very high albuminuria (UACR ≥300 mg/g in 2 out of 3 first morning void samples) and eGFR ≥25 to <75 mL/min/1.73 m² (CKD-EPI)

• Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:

  • For at least 4 weeks prior to the run-in visit, subjects should be treated with either an ACEI or ARB, or both
  • Starting with the run-in visit, subjects should be treated with only an ACEI or ARB
  • For at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment

• Serum potassium ≤4.8 mmol/L at both the run-in and the screening visit

Exclusion criteria

• Known significant non-diabetic renal disease, including clinically relevant renal artery stenosis
• Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run-in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
• Glycated hemoglobin (HbA1c) >12%
• Mean SBP < 90 mmHg at the run-in visit or at the screening visit
• Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association [NYHA] class II - IV) at run-in visit (class 1A recommendation for mineralcorticoid receptor antagonists [MRAs])
• Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
• Dialysis for acute renal failure within 12 weeks of run-in visit
• Renal allograft in place or scheduled within next 12 months from the run-in visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,734 participants in 2 patient groups, including a placebo group

Finerenone (BAY94-8862)

Experimental group

Description:

Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy

Treatment:

Drug: Finerenone (BAY94-8862)

Placebo

Placebo Comparator group

Description:

Participants received matching placebo once daily in addition to standard of care therapy

Treatment:

Drug: Placebo