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

This study is currently recruiting participants.
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Verified September 2017 by Bayer
Information provided by (Responsible Party):
Bayer Identifier:
First received: September 2, 2015
Last updated: September 13, 2017
Last verified: September 2017
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 Intervention Phase
Diabetic Kidney Disease Drug: Finerenone (BAY94-8862) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 48 months) ]

Secondary Outcome Measures:
  • 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) ]
  • Time to all-cause mortality [ Time Frame: Time to total Follow up (Up to 48 months) ]
  • Time to all-cause hospitalizations [ Time Frame: Time to total Follow up (Up to 48 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 48 months) ]
  • Change in urinary albumin-to-creatine ratio (UCAR) from baseline to month 4 [ Time Frame: Baseline to Month 4 ]

Estimated Enrollment: 4800
Actual Study Start Date: September 17, 2015
Estimated Study Completion Date: October 28, 2019
Estimated Primary Completion Date: September 29, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02540993

Contact: Bayer Clinical Trials Contact +49 30 300139003
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 1033 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT02540993     History of Changes
Other Study ID Numbers: 16244
2015-000990-11 ( EudraCT Number )
Study First Received: September 2, 2015
Last Updated: September 13, 2017

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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications processed this record on September 21, 2017