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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.
Verified November 2017 by Bayer
Sponsor:
ClinicalTrials.gov Identifier:
NCT02540993
First Posted: September 4, 2015
Last Update Posted: November 21, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
September 2, 2015
September 4, 2015
November 21, 2017
September 17, 2015
September 29, 2019   (Final data collection date for primary outcome measure)
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) ]
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) ]
Complete list of historical versions of study NCT02540993 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Kidney Disease
  • Drug: Finerenone (BAY94-8862)
    10 mg or 20 mg Finerenone tablet to be given orally, once daily.
  • Drug: Placebo
    Matching placebo to be taken orally, once daily.
  • Experimental: BAY94-8862
    Finerenone tablet
    Intervention: Drug: Finerenone (BAY94-8862)
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4800
October 28, 2019
September 29, 2019   (Final data collection date for primary outcome measure)

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%.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
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
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,   Saudi Arabia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine,   United Kingdom,   United States,   Vietnam
Czech Republic
 
NCT02540993
16244
2015-000990-11 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2017

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