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

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ClinicalTrials.gov Identifier: NCT02540993
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : July 19, 2021
Last Update Posted : July 24, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 2, 2015
First Posted Date  ICMJE September 4, 2015
Results First Submitted Date  ICMJE April 5, 2021
Results First Posted Date  ICMJE July 19, 2021
Last Update Posted Date July 24, 2023
Actual Study Start Date  ICMJE September 17, 2015
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2021)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2015)		 Time to the first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of estimated glomerular filtration rate ( eGFR) ≥ 40% from baseline over at least 4 weeks and renal death. [ Time Frame: Time to total Follow up (Up to 39 months) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
  • Time to first occurrence of the composite endpoint: cardiovascular death or non-fatal cardiovascular events (myocardial infarction, stroke, hospitalization for heart failure) [ Time Frame: Time to total Follow up (Up to 39 months) ]
  • Time to all-cause mortality [ Time Frame: Time to total Follow up (Up to 39 months) ]
  • Time to all-cause hospitalizations [ Time Frame: Time to total Follow up (Up to 39 months) ]
  • Time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR) of ≥ 57% from baseline over at least 4 weeks or renal death. [ Time Frame: Time to total Follow up (Up to 39 months) ]
  • Change in urinary albumin-to-creatine ratio (UCAR) from baseline to month 4 [ Time Frame: Baseline to Month 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Finerenone (BAY94-8862)
    Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
    Intervention: Drug: Finerenone (BAY94-8862)
  • Placebo Comparator: Placebo
    Participants received matching placebo once daily in addition to standard of care therapy
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2018)		 5734
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2015)		 4800
Actual Study Completion Date  ICMJE April 14, 2020
Actual Primary Completion Date April 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   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,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries Czech Republic,   Saudi Arabia
 
Administrative Information
NCT Number  ICMJE NCT02540993
Other Study ID Numbers  ICMJE 16244
2015-000990-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bayer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bayer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP