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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 : Recruiting
First Posted : September 4, 2015
Last Update Posted : January 1, 2018
Information provided by (Responsible Party):

Study Description
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4800 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 : September 29, 2019
Estimated Study Completion Date : October 28, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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 and 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-creatine ratio (UCAR) from baseline to month 4 [ Time Frame: Baseline to Month 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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

Contact: Bayer Clinical Trials Contact +49 30 300139003 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Show 1082 Study Locations
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
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: January 1, 2018
Last Verified: December 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