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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02540993




Registration number
NCT02540993
Ethics application status
Date submitted
2/09/2015
Date registered
4/09/2015
Date last updated
24/07/2023

Titles & IDs
Public title
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Scientific 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
Secondary ID [1] 0 0
2015-000990-11
Secondary ID [2] 0 0
16244
Universal Trial Number (UTN)
Trial acronym
FIDELIO-DKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Finerenone (BAY94-8862)
Treatment: Drugs - Placebo

Experimental: Finerenone (BAY94-8862) - Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy

Placebo comparator: Placebo - Participants received matching placebo once daily in addition to standard of care therapy


Treatment: Drugs: Finerenone (BAY94-8862)
Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to \< 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR = 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

Treatment: Drugs: Placebo
Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR =40% From Baseline Over at Least 4 Weeks, or Renal Death
Timepoint [1] 0 0
From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months
Secondary outcome [1] 0 0
The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure
Timepoint [1] 0 0
From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months
Secondary outcome [2] 0 0
All-cause Mortality
Timepoint [2] 0 0
From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months
Secondary outcome [3] 0 0
All-cause Hospitalization
Timepoint [3] 0 0
From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months
Secondary outcome [4] 0 0
Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4
Timepoint [4] 0 0
From baseline up until Month 4
Secondary outcome [5] 0 0
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of =57% From Baseline Over at Least 4 Weeks, or Renal Death
Timepoint [5] 0 0
From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months

Eligibility
Key inclusion criteria
* Men or women =18 years of age
* Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
* Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:

* persistent high albuminuria (UACR =30 to <300 mg/g in 2 out of 3 first morning void samples) and estimated glomerular filtration rate (eGFR) =25 but <60 mL/min/1.73 m² (CKD EPI) and presence of diabetic retinopathy or
* persistent very high albuminuria (UACR =300 mg/g in 2 out of 3 first morning void samples) and eGFR =25 to <75 mL/min/1.73 m² (CKD-EPI)
* Prior treatment with angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) as follows:

* For at least 4 weeks prior to the run-in visit, subjects should be treated with either an ACEI or ARB, or both
* Starting with the run-in visit, subjects should be treated with only an ACEI or ARB
* For at least 4 weeks prior to the screening visit, subjects should be treated with the maximum tolerated labeled dose (but not below the minimal labeled dose) of only an ACEI or an ARB (not both) preferably without any adjustments to dose or choice of agent or to any other antihypertensive or antiglycemic treatment
* Serum potassium =4.8 mmol/L at both the run-in and the screening visit
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known 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)
* Glycated hemoglobin (HbA1c) >12%
* Mean SBP < 90 mmHg at the run-in visit or at the screening visit
* 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 antagonists [MRAs])
* Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
* Dialysis for acute renal failure within 12 weeks of run-in visit
* Renal allograft in place or scheduled within next 12 months from the run-in visit

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/04/2020
Sample size
Target
Accrual to date
Final
5734
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
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- Garran
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- Gosford
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- Liverpool
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- New Lambton
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- Wollongong
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- Adelaide
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- Heidelberg
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- Reservoir
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- Richmond
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- St. Albans
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- Box Hill
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- Elizabeth Vale
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2605 - Garran
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2250 - Gosford
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2170 - Liverpool
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2305 - New Lambton
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2500 - Wollongong
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3121 - Richmond
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3021 - St. Albans
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3128 - Box Hill
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5112 - Elizabeth Vale
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Hungary
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Ireland
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Israel
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Israel
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Israel
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Israel
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Israel
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Israel
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Israel
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Israel
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Ramat Gan
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Israel
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Israel
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Israel
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Tel Aviv
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Israel
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Israel
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Israel
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Gunma
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Japan
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Russian Federation
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Spain
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Spain
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Spain
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Spain
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Switzerland
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Taiwan
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Taiwan
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Taiwan
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Thailand
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Turkey
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Turkey
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United Kingdom
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United Kingdom
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United Kingdom
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT02540993