Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Finerenone (BAY94-8862)
Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
  • Drug: Finerenone (BAY94-8862)
    Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to < 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR ≥ 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment
Placebo Comparator
Placebo
Participants received matching placebo once daily in addition to standard of care therapy
  • Drug: Placebo
    Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

More Details

Status
Completed
Sponsor
Bayer

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.