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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Kidney Disease | Drug: Finerenone (BAY94-8862) Drug: Placebo | Phase 3 |
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 |

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. |
- 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) ]
- 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-creatinine ratio (UACR) from baseline to month 4 [ Time Frame: Baseline to Month 4 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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%.

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

Study Director: | Bayer Study Director | Bayer |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Type 2 Diabetes Kidney diseases |
Kidney Diseases Diabetic Nephropathies Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Urologic Diseases Diabetes Complications |