Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02540993
• Date of registration: 02/09/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease FIDELIO-DKD
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
• Date of first enrolment: September 17, 2015
• Target sample size: 5734
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02540993
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Vietnam

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Intervention(s)

Drug: Finerenone (BAY94-8862)

Drug: Placebo

Primary Outcome(s)

The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR =40% From Baseline Over at Least 4 Weeks, or Renal Death [Time Frame: From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months]

Secondary Outcome(s)

Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 [Time Frame: From baseline up until Month 4]

The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure [Time Frame: From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months]

All-cause Mortality [Time Frame: From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months]

The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of =57% From Baseline Over at Least 4 Weeks, or Renal Death [Time Frame: From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months]

All-cause Hospitalization [Time Frame: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months]

Secondary ID(s)

16244

2015-000990-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/07/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02540993