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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 : Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

Condition or disease Intervention/treatment Phase
Diabetic 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
Estimated Primary Completion Date : April 26, 2020
Estimated Study Completion Date : May 25, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BAY94-8862
Finerenone tablet
 Drug: Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily.
Placebo Comparator: Placebo
Matching placebo
 Drug: Placebo
Matching placebo to be taken orally, once daily.


Outcome Measures
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Primary Outcome Measures :
  1. 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 or renal death. [ Time Frame: Time to total Follow up (Up to 48 months) ]

Secondary Outcome Measures :
  1. 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 48 months) ]
  2. Time to all-cause mortality [ Time Frame: Time to total Follow up (Up to 48 months) ]
  3. Time to all-cause hospitalizations [ Time Frame: Time to total Follow up (Up to 48 months) ]
  4. 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 48 months) ]
  5. Change in urinary albumin-to-creatinine ratio (UACR) from baseline to month 4 [ Time Frame: Baseline to Month 4 ]

Eligibility Criteria
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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
  • Subjects with Type 2 diabetes mellitus as defined by the American Diabetes Association
  • Diagnosis of diabetic kidney disease (DKD) with persistent high albuminuria or persistent very high albuminuria at the Run-in and Screening visits:
  • Pretreated with either angiotensin-converting enzyme inhibitor(ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
  • Serum potassium <=4.8 mmol/L.

Exclusion Criteria:

  • Confirmed 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)
  • 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 antagonist (MRAs)
  • Dialysis for acute renal failure within 12 weeks of run in visit
  • Renal allograft in place or scheduled kidney transplant within next 12 months
  • Glycated hemoglobin HbA1c > 12%.
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


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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02540993     History of Changes
Other Study ID Numbers: 16244
2015-000990-11 ( EudraCT Number )
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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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:
Type 2 Diabetes
Kidney diseases
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications