Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-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: NCT02545049
Recruitment Status : Active, not recruiting
First Posted : September 9, 2015
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE September 2, 2015
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE September 17, 2015
Estimated Primary Completion Date June 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2017)
Time to the first occurrence of the composite endpoint of cardiovascular death and non-fatal cardiovascular events (myocardial infarction, stroke, or hospitalization for heart failure) [ Time Frame: Time to total follow up (Up to 53 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2015)
Time to the first occurrence of the composite endpoint of cardiovascular death and non-fatal cardiovascular events (myocardial infarction, stroke, or hospitalization for heart failure) [ Time Frame: Time to total Follow up (Up to 36 months) ]
Change History Complete list of historical versions of study NCT02545049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2017)
  • Time to first occurrence of the following composite endpoints: onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR)of ≥40% from baseline over at least 4 weeks and renal death [ Time Frame: Time to total Follow up (Up to 53 months) ]
  • Time to all-cause mortality [ Time Frame: Time to total Follow up (Up to 53 months) ]
  • Time to all-cause hospitalization [ Time Frame: Time to total Follow up (Up to 53 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 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 53 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2015)
  • Time to first occurrence of the following composite endpoints: onset of kidney failure, a sustained decrease in estimated glomerular filtration rate (eGFR)of ≥40% from baseline over at least 4 weeks and renal death [ Time Frame: Time to total Follow up (Up to 36 months) ]
  • Time to all-cause mortality [ Time Frame: Time to total Follow up (Up to 36 months) ]
  • Time to all-cause hospitalization [ Time Frame: Time to total Follow up (Up to 36 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 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 36 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Kidney Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: BAY94-8862
    Finerenone tablet
    Intervention: Drug: Finerenone (BAY94-8862)
  • Placebo Comparator: Placebo
    Matching placebo
    Intervention: Drug: Placebo
Publications * Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filippatos G, Nowack C, Kolkhof P, Joseph A, Mentenich N, Pitt B; FIGARO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 17, 2019)
7437
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2015)
6400
Estimated Study Completion Date  ICMJE July 21, 2021
Estimated Primary Completion Date June 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women ≥18 years of age
  • Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
  • Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
  • 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 or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean 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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02545049
Other Study ID Numbers  ICMJE 17530
2015-000950-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2019

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