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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540993
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Finerenone (BAY94-8862) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5734 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : April 14, 2020
Actual Study Completion Date : April 14, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Count of participants and time from randomization to the first occurrence of the primary renal composite outcome, onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.


Secondary Outcome Measures :
  1. 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 ]
    Count of participants and time from randomization to the first occurrence of the key secondary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.

  2. 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 ]
    Count of participants and time from randomization until death due to any cause were evaluated. Number of participants with outcome death is reported as descriptive result and hazard ratio is reported as statistical analysis. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.

  3. 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 ]
    Count of participants and time from randomization to the first occurrence of a hospitalization event were evaluated. Number of participants with the event is reported as descriptive result and hazard ratio is reported as statistical analysis.

  4. Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 [ Time Frame: From baseline up until Month 4 ]
    First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change.

  5. 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 ]
    Count of participants and time from randomization to the first occurrence of the secondary renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540993


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] February 26, 2019
Statistical Analysis Plan  [PDF] February 14, 2020

More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02540993    
Other Study ID Numbers: 16244
2015-000990-11 ( EudraCT Number )
First Posted: September 4, 2015    Key Record Dates
Results First Posted: July 19, 2021
Last Update Posted: July 19, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
CKD
Diabetic Kidney Disease
Type 2 Diabetes
Kidney diseases
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes
Diabetes Complications