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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02545049
Registration number
NCT02545049
Ethics application status
Date submitted
2/09/2015
Date registered
9/09/2015
Titles & IDs
Public title
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
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Scientific title
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.
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Secondary ID [1]
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2015-000950-39
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Secondary ID [2]
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17530
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Universal Trial Number (UTN)
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Trial acronym
FIGARO-DKD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetic Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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0
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0
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Kidney disease
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Metabolic and Endocrine
0
0
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Finerenone (BAY94-8862)
Treatment: Drugs - Placebo
Experimental: BAY94-8862 - Finerenone tablet
Placebo comparator: Placebo - Matching placebo
Treatment: Drugs: Finerenone (BAY94-8862)
10 mg or 20 mg Finerenone tablet to be given orally, once daily.
Treatment: Drugs: Placebo
Matching placebo to be taken orally, once daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure.
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Assessment method [1]
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Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.
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Timepoint [1]
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From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
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Secondary outcome [1]
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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.
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Assessment method [1]
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Number of participants with 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 were reported as descriptive result.
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Timepoint [1]
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From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
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Secondary outcome [2]
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All-cause Hospitalization
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Assessment method [2]
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Number of participants with first occurrence of a hospitalization event were reported as descriptive result.
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Timepoint [2]
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From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 months
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Secondary outcome [3]
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All-cause Mortality
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Assessment method [3]
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Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.
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Timepoint [3]
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From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months
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Secondary outcome [4]
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Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4
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Assessment method [4]
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First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change.
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Timepoint [4]
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From baseline up until Month 4
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Secondary outcome [5]
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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
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Assessment method [5]
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Number of participants with first occurrence of the renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of =57% from baseline over at least 4 weeks, or renal death were reported as descriptive result.
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Timepoint [5]
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From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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%
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/09/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/02/2021
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Sample size
Target
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Accrual to date
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Final
7352
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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- Garran
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- Gosford
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- Elizabeth Vale
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2605 - Garran
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2250 - Gosford
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2259 - Kanwal
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2170 - Liverpool
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2305 - New Lambton Heights
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2500 - Wollongong
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4064 - Brisbane
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5000 - Adelaide
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Recruitment postcode(s) [9]
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3065 - Fitzroy
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3081 - Heidelberg
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3052 - Melbourne
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3181 - Prahran
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3073 - Reservoir
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3121 - Richmond
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3021 - St. Albans
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Recruitment postcode(s) [16]
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5112 - Elizabeth Vale
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Recruitment outside Australia
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0
Colombia
Query!
State/province [109]
0
0
Distrito Capital De Bogotá
Query!
Country [110]
0
0
Colombia
Query!
State/province [110]
0
0
Nariño
Query!
Country [111]
0
0
Colombia
Query!
State/province [111]
0
0
Quindío
Query!
Country [112]
0
0
Colombia
Query!
State/province [112]
0
0
Risaralda
Query!
Country [113]
0
0
Colombia
Query!
State/province [113]
0
0
Valle Del Cauca
Query!
Country [114]
0
0
Colombia
Query!
State/province [114]
0
0
Barranquilla
Query!
Country [115]
0
0
Colombia
Query!
State/province [115]
0
0
Bogota
Query!
Country [116]
0
0
Colombia
Query!
State/province [116]
0
0
Floridablanca
Query!
Country [117]
0
0
Colombia
Query!
State/province [117]
0
0
Medellín
Query!
Country [118]
0
0
Czechia
Query!
State/province [118]
0
0
Beroun
Query!
Country [119]
0
0
Czechia
Query!
State/province [119]
0
0
Brandys nad Labem
Query!
Country [120]
0
0
Czechia
Query!
State/province [120]
0
0
Breclav
Query!
Country [121]
0
0
Czechia
Query!
State/province [121]
0
0
Ceska Lipa
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
Cesky Krumlov
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Frydek-Mistek
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Hodonin
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Holesov
Query!
Country [126]
0
0
Czechia
Query!
State/province [126]
0
0
Hranice
Query!
Country [127]
0
0
Czechia
Query!
State/province [127]
0
0
Koprivnice
Query!
Country [128]
0
0
Czechia
Query!
State/province [128]
0
0
Krnov
Query!
Country [129]
0
0
Czechia
Query!
State/province [129]
0
0
Mlada Boleslav
Query!
Country [130]
0
0
Czechia
Query!
State/province [130]
0
0
Olomouc
Query!
Country [131]
0
0
Czechia
Query!
State/province [131]
0
0
Ostrava
Query!
Country [132]
0
0
Czechia
Query!
State/province [132]
0
0
Plzen
Query!
Country [133]
0
0
Czechia
Query!
State/province [133]
0
0
Prague 6
Query!
Country [134]
0
0
Czechia
Query!
State/province [134]
0
0
Praha 2
Query!
Country [135]
0
0
Czechia
Query!
State/province [135]
0
0
Praha 4
Query!
Country [136]
0
0
Czechia
Query!
State/province [136]
0
0
Praha 5
Query!
Country [137]
0
0
Czechia
Query!
State/province [137]
0
0
Vlasim
Query!
Country [138]
0
0
Denmark
Query!
State/province [138]
0
0
Aalborg
Query!
Country [139]
0
0
Denmark
Query!
State/province [139]
0
0
Aarhus N
Query!
Country [140]
0
0
Denmark
Query!
State/province [140]
0
0
Esbjerg
Query!
Country [141]
0
0
Denmark
Query!
State/province [141]
0
0
Gentofte
Query!
Country [142]
0
0
Denmark
Query!
State/province [142]
0
0
Hellerup
Query!
Country [143]
0
0
Denmark
Query!
State/province [143]
0
0
Herlev
Query!
Country [144]
0
0
Denmark
Query!
State/province [144]
0
0
Hillerød
Query!
Country [145]
0
0
Denmark
Query!
State/province [145]
0
0
Holbæk
Query!
Country [146]
0
0
Denmark
Query!
State/province [146]
0
0
Holstebro
Query!
Country [147]
0
0
Denmark
Query!
State/province [147]
0
0
Hvidovre
Query!
Country [148]
0
0
Denmark
Query!
State/province [148]
0
0
Kolding
Query!
Country [149]
0
0
Denmark
Query!
State/province [149]
0
0
København NV
Query!
Country [150]
0
0
Denmark
Query!
State/province [150]
0
0
Odense C
Query!
Country [151]
0
0
Denmark
Query!
State/province [151]
0
0
Svendborg
Query!
Country [152]
0
0
Denmark
Query!
State/province [152]
0
0
Viborg
Query!
Country [153]
0
0
Finland
Query!
State/province [153]
0
0
Jyväskylä
Query!
Country [154]
0
0
Finland
Query!
State/province [154]
0
0
Kajaani
Query!
Country [155]
0
0
Finland
Query!
State/province [155]
0
0
Kerava
Query!
Country [156]
0
0
Finland
Query!
State/province [156]
0
0
Klaukkala
Query!
Country [157]
0
0
Finland
Query!
State/province [157]
0
0
Kuopio
Query!
Country [158]
0
0
Finland
Query!
State/province [158]
0
0
Nurmijärvi
Query!
Country [159]
0
0
Finland
Query!
State/province [159]
0
0
Oulu
Query!
Country [160]
0
0
Finland
Query!
State/province [160]
0
0
Rauma
Query!
Country [161]
0
0
Finland
Query!
State/province [161]
0
0
Seinäjoki
Query!
Country [162]
0
0
Finland
Query!
State/province [162]
0
0
Tampere
Query!
Country [163]
0
0
Finland
Query!
State/province [163]
0
0
Turku
Query!
Country [164]
0
0
Finland
Query!
State/province [164]
0
0
Vantaa
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Bois-guillaume
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Boulogne Sur Mer
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Brest
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
COLMAR Cedex
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
Dijon
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Grenoble Cedex 9
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Le Coudray
Query!
Country [172]
0
0
France
Query!
State/province [172]
0
0
Le Creusot
Query!
Country [173]
0
0
France
Query!
State/province [173]
0
0
Lyon Cedex
Query!
Country [174]
0
0
France
Query!
State/province [174]
0
0
Mulhouse
Query!
Country [175]
0
0
France
Query!
State/province [175]
0
0
NIMES cedex 9
Query!
Country [176]
0
0
France
Query!
State/province [176]
0
0
Paris
Query!
Country [177]
0
0
France
Query!
State/province [177]
0
0
Saint Herblain
Query!
Country [178]
0
0
France
Query!
State/province [178]
0
0
Tourcoing
Query!
Country [179]
0
0
France
Query!
State/province [179]
0
0
Vandoeuvre-les-nancy
Query!
Country [180]
0
0
France
Query!
State/province [180]
0
0
Venissieux
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Baden-Württemberg
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Bayern
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Brandenburg
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Hessen
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Niedersachsen
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Nordrhein-Westfalen
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Rheinland-Pfalz
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Sachsen-Anhalt
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Sachsen
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Thüringen
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Berlin
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Hamburg
Query!
Country [193]
0
0
Greece
Query!
State/province [193]
0
0
Alexandroupolis
Query!
Country [194]
0
0
Greece
Query!
State/province [194]
0
0
Athens
Query!
Country [195]
0
0
Greece
Query!
State/province [195]
0
0
Chaidari
Query!
Country [196]
0
0
Greece
Query!
State/province [196]
0
0
Larissa
Query!
Country [197]
0
0
Greece
Query!
State/province [197]
0
0
Nea Ionia
Query!
Country [198]
0
0
Greece
Query!
State/province [198]
0
0
Thessaloniki
Query!
Country [199]
0
0
Hong Kong
Query!
State/province [199]
0
0
Hong Kong
Query!
Country [200]
0
0
Hong Kong
Query!
State/province [200]
0
0
Shatin
Query!
Country [201]
0
0
Hong Kong
Query!
State/province [201]
0
0
Sheung Wan
Query!
Country [202]
0
0
Hong Kong
Query!
State/province [202]
0
0
Wong Tai Sin
Query!
Country [203]
0
0
Hungary
Query!
State/province [203]
0
0
Baja
Query!
Country [204]
0
0
Hungary
Query!
State/province [204]
0
0
Balatonfured
Query!
Country [205]
0
0
Hungary
Query!
State/province [205]
0
0
Budapest
Query!
Country [206]
0
0
Hungary
Query!
State/province [206]
0
0
Debrecen
Query!
Country [207]
0
0
Hungary
Query!
State/province [207]
0
0
Eger
Query!
Country [208]
0
0
Hungary
Query!
State/province [208]
0
0
Kistarcsa
Query!
Country [209]
0
0
Hungary
Query!
State/province [209]
0
0
Nyiregyhaza
Query!
Country [210]
0
0
Hungary
Query!
State/province [210]
0
0
Papa
Query!
Country [211]
0
0
Hungary
Query!
State/province [211]
0
0
Siofok
Query!
Country [212]
0
0
Hungary
Query!
State/province [212]
0
0
Szeged
Query!
Country [213]
0
0
Hungary
Query!
State/province [213]
0
0
Szekesfehervar
Query!
Country [214]
0
0
Hungary
Query!
State/province [214]
0
0
Szentes
Query!
Country [215]
0
0
Hungary
Query!
State/province [215]
0
0
Szombathely
Query!
Country [216]
0
0
Ireland
Query!
State/province [216]
0
0
Cork
Query!
Country [217]
0
0
Ireland
Query!
State/province [217]
0
0
Dublin
Query!
Country [218]
0
0
Ireland
Query!
State/province [218]
0
0
Galway
Query!
Country [219]
0
0
Israel
Query!
State/province [219]
0
0
Afula
Query!
Country [220]
0
0
Israel
Query!
State/province [220]
0
0
Ashkelon
Query!
Country [221]
0
0
Israel
Query!
State/province [221]
0
0
Beer Sheva
Query!
Country [222]
0
0
Israel
Query!
State/province [222]
0
0
Haifa
Query!
Country [223]
0
0
Israel
Query!
State/province [223]
0
0
Holon
Query!
Country [224]
0
0
Israel
Query!
State/province [224]
0
0
Jerusalem
Query!
Country [225]
0
0
Israel
Query!
State/province [225]
0
0
Kfar Saba
Query!
Country [226]
0
0
Israel
Query!
State/province [226]
0
0
Nahariya
Query!
Country [227]
0
0
Israel
Query!
State/province [227]
0
0
Nazareth
Query!
Country [228]
0
0
Israel
Query!
State/province [228]
0
0
Ramat Gan
Query!
Country [229]
0
0
Israel
Query!
State/province [229]
0
0
Rehovot
Query!
Country [230]
0
0
Israel
Query!
State/province [230]
0
0
Sakhnin
Query!
Country [231]
0
0
Israel
Query!
State/province [231]
0
0
Tel Aviv
Query!
Country [232]
0
0
Israel
Query!
State/province [232]
0
0
Tiberias
Query!
Country [233]
0
0
Israel
Query!
State/province [233]
0
0
Zefat
Query!
Country [234]
0
0
Israel
Query!
State/province [234]
0
0
Zerifin
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Campania
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Emilia-Romagna
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
Liguria
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
Lombardia
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Piemonte
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
Sardegna
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
Sicilia
Query!
Country [242]
0
0
Italy
Query!
State/province [242]
0
0
Toscana
Query!
Country [243]
0
0
Italy
Query!
State/province [243]
0
0
Veneto
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Aichi
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Chiba
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Ehime
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Fukuoka
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Fukushima
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Gifu
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Gunma
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Hiroshima
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Hokkaido
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Hyogo
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Ibaraki
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Ishikawa
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Kagawa
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Kanagawa
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Kumamoto
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Nagasaki
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Oita
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Okinawa
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Osaka
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Saitama
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Shiga
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Shizuoka
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Tochigi
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Tokyo
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Fukui
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Kagoshima
Query!
Country [270]
0
0
Korea, Republic of
Query!
State/province [270]
0
0
Gang''weondo
Query!
Country [271]
0
0
Korea, Republic of
Query!
State/province [271]
0
0
Gyeonggido
Query!
Country [272]
0
0
Korea, Republic of
Query!
State/province [272]
0
0
Seoul Teugbyeolsi
Query!
Country [273]
0
0
Korea, Republic of
Query!
State/province [273]
0
0
Busan
Query!
Country [274]
0
0
Korea, Republic of
Query!
State/province [274]
0
0
Daegu
Query!
Country [275]
0
0
Korea, Republic of
Query!
State/province [275]
0
0
Seoul
Query!
Country [276]
0
0
Lithuania
Query!
State/province [276]
0
0
Kaunas
Query!
Country [277]
0
0
Lithuania
Query!
State/province [277]
0
0
Klaipeda
Query!
Country [278]
0
0
Lithuania
Query!
State/province [278]
0
0
Utena
Query!
Country [279]
0
0
Lithuania
Query!
State/province [279]
0
0
Vilnius
Query!
Country [280]
0
0
Malaysia
Query!
State/province [280]
0
0
Johor Bahru
Query!
Country [281]
0
0
Malaysia
Query!
State/province [281]
0
0
Kelantan
Query!
Country [282]
0
0
Malaysia
Query!
State/province [282]
0
0
Kuala Lumpur
Query!
Country [283]
0
0
Malaysia
Query!
State/province [283]
0
0
Pahang
Query!
Country [284]
0
0
Malaysia
Query!
State/province [284]
0
0
Perak
Query!
Country [285]
0
0
Malaysia
Query!
State/province [285]
0
0
Pulau Pinang
Query!
Country [286]
0
0
Malaysia
Query!
State/province [286]
0
0
Putrajaya
Query!
Country [287]
0
0
Malaysia
Query!
State/province [287]
0
0
Selangor
Query!
Country [288]
0
0
Mexico
Query!
State/province [288]
0
0
Distrito Federal
Query!
Country [289]
0
0
Mexico
Query!
State/province [289]
0
0
Jalisco
Query!
Country [290]
0
0
Mexico
Query!
State/province [290]
0
0
Morelos
Query!
Country [291]
0
0
Mexico
Query!
State/province [291]
0
0
Nuevo Leon
Query!
Country [292]
0
0
Mexico
Query!
State/province [292]
0
0
Querétaro
Query!
Country [293]
0
0
Mexico
Query!
State/province [293]
0
0
Sinaloa
Query!
Country [294]
0
0
Mexico
Query!
State/province [294]
0
0
Veracruz
Query!
Country [295]
0
0
Mexico
Query!
State/province [295]
0
0
Aguascalientes
Query!
Country [296]
0
0
Mexico
Query!
State/province [296]
0
0
Chihuahua
Query!
Country [297]
0
0
Mexico
Query!
State/province [297]
0
0
Durango
Query!
Country [298]
0
0
Netherlands
Query!
State/province [298]
0
0
Alkmaar
Query!
Country [299]
0
0
Netherlands
Query!
State/province [299]
0
0
Almere
Query!
Country [300]
0
0
Netherlands
Query!
State/province [300]
0
0
Amersfoort
Query!
Country [301]
0
0
Netherlands
Query!
State/province [301]
0
0
Amsterdam
Query!
Country [302]
0
0
Netherlands
Query!
State/province [302]
0
0
Apeldoorn
Query!
Country [303]
0
0
Netherlands
Query!
State/province [303]
0
0
Breda
Query!
Country [304]
0
0
Netherlands
Query!
State/province [304]
0
0
Den Haag
Query!
Country [305]
0
0
Netherlands
Query!
State/province [305]
0
0
Eindhoven
Query!
Country [306]
0
0
Netherlands
Query!
State/province [306]
0
0
Geleen
Query!
Country [307]
0
0
Netherlands
Query!
State/province [307]
0
0
Groningen
Query!
Country [308]
0
0
Netherlands
Query!
State/province [308]
0
0
Hoogeveen
Query!
Country [309]
0
0
Netherlands
Query!
State/province [309]
0
0
Zwijndrecht
Query!
Country [310]
0
0
New Zealand
Query!
State/province [310]
0
0
Auckland
Query!
Country [311]
0
0
New Zealand
Query!
State/province [311]
0
0
Christchurch
Query!
Country [312]
0
0
New Zealand
Query!
State/province [312]
0
0
Hamilton
Query!
Country [313]
0
0
New Zealand
Query!
State/province [313]
0
0
Hawkes Bay
Query!
Country [314]
0
0
New Zealand
Query!
State/province [314]
0
0
Palmerston North
Query!
Country [315]
0
0
New Zealand
Query!
State/province [315]
0
0
Tauranga
Query!
Country [316]
0
0
New Zealand
Query!
State/province [316]
0
0
Wellington
Query!
Country [317]
0
0
Norway
Query!
State/province [317]
0
0
Hamar
Query!
Country [318]
0
0
Norway
Query!
State/province [318]
0
0
Kløfta
Query!
Country [319]
0
0
Norway
Query!
State/province [319]
0
0
Kongsvinger
Query!
Country [320]
0
0
Norway
Query!
State/province [320]
0
0
Kristiansand
Query!
Country [321]
0
0
Norway
Query!
State/province [321]
0
0
Levanger
Query!
Country [322]
0
0
Norway
Query!
State/province [322]
0
0
Lierskogen
Query!
Country [323]
0
0
Norway
Query!
State/province [323]
0
0
Oslo
Query!
Country [324]
0
0
Norway
Query!
State/province [324]
0
0
Skedsmokorset
Query!
Country [325]
0
0
Norway
Query!
State/province [325]
0
0
Ålesund
Query!
Country [326]
0
0
Philippines
Query!
State/province [326]
0
0
Iloilo City
Query!
Country [327]
0
0
Philippines
Query!
State/province [327]
0
0
Marikina City
Query!
Country [328]
0
0
Philippines
Query!
State/province [328]
0
0
Pasig City
Query!
Country [329]
0
0
Philippines
Query!
State/province [329]
0
0
Quezon City
Query!
Country [330]
0
0
Poland
Query!
State/province [330]
0
0
Bialystok
Query!
Country [331]
0
0
Poland
Query!
State/province [331]
0
0
Bydgoszcz
Query!
Country [332]
0
0
Poland
Query!
State/province [332]
0
0
Chojnice
Query!
Country [333]
0
0
Poland
Query!
State/province [333]
0
0
Gdansk
Query!
Country [334]
0
0
Poland
Query!
State/province [334]
0
0
Gdynia
Query!
Country [335]
0
0
Poland
Query!
State/province [335]
0
0
Katowice
Query!
Country [336]
0
0
Poland
Query!
State/province [336]
0
0
Krakow
Query!
Country [337]
0
0
Poland
Query!
State/province [337]
0
0
Lodz
Query!
Country [338]
0
0
Poland
Query!
State/province [338]
0
0
Lublin
Query!
Country [339]
0
0
Poland
Query!
State/province [339]
0
0
Poznan
Query!
Country [340]
0
0
Poland
Query!
State/province [340]
0
0
Rzeszow
Query!
Country [341]
0
0
Poland
Query!
State/province [341]
0
0
Skorzewo
Query!
Country [342]
0
0
Poland
Query!
State/province [342]
0
0
Szczecin
Query!
Country [343]
0
0
Poland
Query!
State/province [343]
0
0
Torun
Query!
Country [344]
0
0
Poland
Query!
State/province [344]
0
0
Warszawa
Query!
Country [345]
0
0
Poland
Query!
State/province [345]
0
0
Wroclaw
Query!
Country [346]
0
0
Poland
Query!
State/province [346]
0
0
Zabrze
Query!
Country [347]
0
0
Portugal
Query!
State/province [347]
0
0
Castelo Branco
Query!
Country [348]
0
0
Portugal
Query!
State/province [348]
0
0
Lisboa
Query!
Country [349]
0
0
Portugal
Query!
State/province [349]
0
0
Porto
Query!
Country [350]
0
0
Portugal
Query!
State/province [350]
0
0
Região Autónoma Da Madeira
Query!
Country [351]
0
0
Portugal
Query!
State/province [351]
0
0
Santarém
Query!
Country [352]
0
0
Portugal
Query!
State/province [352]
0
0
Setúbal
Query!
Country [353]
0
0
Portugal
Query!
State/province [353]
0
0
Almada
Query!
Country [354]
0
0
Portugal
Query!
State/province [354]
0
0
Amadora
Query!
Country [355]
0
0
Portugal
Query!
State/province [355]
0
0
Braga
Query!
Country [356]
0
0
Portugal
Query!
State/province [356]
0
0
Faro
Query!
Country [357]
0
0
Portugal
Query!
State/province [357]
0
0
Leiria
Query!
Country [358]
0
0
Portugal
Query!
State/province [358]
0
0
Viana do Castelo
Query!
Country [359]
0
0
Puerto Rico
Query!
State/province [359]
0
0
Cidra
Query!
Country [360]
0
0
Puerto Rico
Query!
State/province [360]
0
0
San Juan
Query!
Country [361]
0
0
Romania
Query!
State/province [361]
0
0
Alba
Query!
Country [362]
0
0
Romania
Query!
State/province [362]
0
0
Bihor
Query!
Country [363]
0
0
Romania
Query!
State/province [363]
0
0
Maramures
Query!
Country [364]
0
0
Romania
Query!
State/province [364]
0
0
Prahova
Query!
Country [365]
0
0
Romania
Query!
State/province [365]
0
0
Timis
Query!
Country [366]
0
0
Romania
Query!
State/province [366]
0
0
Brasov
Query!
Country [367]
0
0
Romania
Query!
State/province [367]
0
0
Bucuresti
Query!
Country [368]
0
0
Romania
Query!
State/province [368]
0
0
Cluj-Napoca
Query!
Country [369]
0
0
Romania
Query!
State/province [369]
0
0
Galati
Query!
Country [370]
0
0
Romania
Query!
State/province [370]
0
0
Iasi
Query!
Country [371]
0
0
Romania
Query!
State/province [371]
0
0
Oradea
Query!
Country [372]
0
0
Romania
Query!
State/province [372]
0
0
Satu Mare
Query!
Country [373]
0
0
Romania
Query!
State/province [373]
0
0
Timisoara
Query!
Country [374]
0
0
Russian Federation
Query!
State/province [374]
0
0
Arkhangelsk
Query!
Country [375]
0
0
Russian Federation
Query!
State/province [375]
0
0
Barnaul
Query!
Country [376]
0
0
Russian Federation
Query!
State/province [376]
0
0
Chelyabinsk
Query!
Country [377]
0
0
Russian Federation
Query!
State/province [377]
0
0
Irkutsk
Query!
Country [378]
0
0
Russian Federation
Query!
State/province [378]
0
0
Izhevsk
Query!
Country [379]
0
0
Russian Federation
Query!
State/province [379]
0
0
Kazan
Query!
Country [380]
0
0
Russian Federation
Query!
State/province [380]
0
0
Kemerovo
Query!
Country [381]
0
0
Russian Federation
Query!
State/province [381]
0
0
Kirov
Query!
Country [382]
0
0
Russian Federation
Query!
State/province [382]
0
0
Krasnodar
Query!
Country [383]
0
0
Russian Federation
Query!
State/province [383]
0
0
Krasnoyarsk
Query!
Country [384]
0
0
Russian Federation
Query!
State/province [384]
0
0
Kursk
Query!
Country [385]
0
0
Russian Federation
Query!
State/province [385]
0
0
Moscow
Query!
Country [386]
0
0
Russian Federation
Query!
State/province [386]
0
0
Nizhny Novgorod
Query!
Country [387]
0
0
Russian Federation
Query!
State/province [387]
0
0
Novosibirsk
Query!
Country [388]
0
0
Russian Federation
Query!
State/province [388]
0
0
Omsk
Query!
Country [389]
0
0
Russian Federation
Query!
State/province [389]
0
0
Orenburg
Query!
Country [390]
0
0
Russian Federation
Query!
State/province [390]
0
0
Perm
Query!
Country [391]
0
0
Russian Federation
Query!
State/province [391]
0
0
Saratov
Query!
Country [392]
0
0
Russian Federation
Query!
State/province [392]
0
0
St. Petersburg
Query!
Country [393]
0
0
Russian Federation
Query!
State/province [393]
0
0
Stavropol
Query!
Country [394]
0
0
Russian Federation
Query!
State/province [394]
0
0
Syktyvkar
Query!
Country [395]
0
0
Russian Federation
Query!
State/province [395]
0
0
Voronezh
Query!
Country [396]
0
0
Russian Federation
Query!
State/province [396]
0
0
Yaroslavl
Query!
Country [397]
0
0
Russian Federation
Query!
State/province [397]
0
0
Yekaterinburg
Query!
Country [398]
0
0
Singapore
Query!
State/province [398]
0
0
Singapore
Query!
Country [399]
0
0
Slovakia
Query!
State/province [399]
0
0
Banska Bystrica
Query!
Country [400]
0
0
Slovakia
Query!
State/province [400]
0
0
Bardejov
Query!
Country [401]
0
0
Slovakia
Query!
State/province [401]
0
0
Nitra
Query!
Country [402]
0
0
Slovakia
Query!
State/province [402]
0
0
Rimavska Sobota
Query!
Country [403]
0
0
Slovakia
Query!
State/province [403]
0
0
Roznava
Query!
Country [404]
0
0
Slovakia
Query!
State/province [404]
0
0
Zilina
Query!
Country [405]
0
0
South Africa
Query!
State/province [405]
0
0
Eastern Cape
Query!
Country [406]
0
0
South Africa
Query!
State/province [406]
0
0
Gauteng
Query!
Country [407]
0
0
South Africa
Query!
State/province [407]
0
0
Kwazulu-Natal
Query!
Country [408]
0
0
South Africa
Query!
State/province [408]
0
0
Mpumalanga
Query!
Country [409]
0
0
South Africa
Query!
State/province [409]
0
0
Western Cape
Query!
Country [410]
0
0
Spain
Query!
State/province [410]
0
0
A Coruña
Query!
Country [411]
0
0
Spain
Query!
State/province [411]
0
0
Barcelona
Query!
Country [412]
0
0
Spain
Query!
State/province [412]
0
0
Cádiz
Query!
Country [413]
0
0
Spain
Query!
State/province [413]
0
0
Lugo
Query!
Country [414]
0
0
Spain
Query!
State/province [414]
0
0
Madrid
Query!
Country [415]
0
0
Spain
Query!
State/province [415]
0
0
Valencia
Query!
Country [416]
0
0
Spain
Query!
State/province [416]
0
0
Córdoba
Query!
Country [417]
0
0
Spain
Query!
State/province [417]
0
0
Granada
Query!
Country [418]
0
0
Spain
Query!
State/province [418]
0
0
Jaén
Query!
Country [419]
0
0
Spain
Query!
State/province [419]
0
0
Málaga
Query!
Country [420]
0
0
Sweden
Query!
State/province [420]
0
0
Göteborg
Query!
Country [421]
0
0
Sweden
Query!
State/province [421]
0
0
Lund
Query!
Country [422]
0
0
Sweden
Query!
State/province [422]
0
0
Rättvik
Query!
Country [423]
0
0
Sweden
Query!
State/province [423]
0
0
Skövde
Query!
Country [424]
0
0
Sweden
Query!
State/province [424]
0
0
Stockholm
Query!
Country [425]
0
0
Sweden
Query!
State/province [425]
0
0
Uppsala
Query!
Country [426]
0
0
Sweden
Query!
State/province [426]
0
0
Örebro
Query!
Country [427]
0
0
Switzerland
Query!
State/province [427]
0
0
Sankt Gallen
Query!
Country [428]
0
0
Switzerland
Query!
State/province [428]
0
0
Solothurn
Query!
Country [429]
0
0
Switzerland
Query!
State/province [429]
0
0
Vaud
Query!
Country [430]
0
0
Switzerland
Query!
State/province [430]
0
0
Bern
Query!
Country [431]
0
0
Switzerland
Query!
State/province [431]
0
0
Genève
Query!
Country [432]
0
0
Taiwan
Query!
State/province [432]
0
0
Changhua
Query!
Country [433]
0
0
Taiwan
Query!
State/province [433]
0
0
Kaohsiung
Query!
Country [434]
0
0
Taiwan
Query!
State/province [434]
0
0
New Taipei City
Query!
Country [435]
0
0
Taiwan
Query!
State/province [435]
0
0
Taichung
Query!
Country [436]
0
0
Taiwan
Query!
State/province [436]
0
0
Taipei
Query!
Country [437]
0
0
Taiwan
Query!
State/province [437]
0
0
Taoyuan
Query!
Country [438]
0
0
Thailand
Query!
State/province [438]
0
0
Bangkok
Query!
Country [439]
0
0
Thailand
Query!
State/province [439]
0
0
Chiangmai
Query!
Country [440]
0
0
Thailand
Query!
State/province [440]
0
0
Khon Kaen
Query!
Country [441]
0
0
Turkey
Query!
State/province [441]
0
0
Ankara
Query!
Country [442]
0
0
Turkey
Query!
State/province [442]
0
0
Antalya
Query!
Country [443]
0
0
Turkey
Query!
State/province [443]
0
0
Aydin
Query!
Country [444]
0
0
Turkey
Query!
State/province [444]
0
0
Istanbul
Query!
Country [445]
0
0
Turkey
Query!
State/province [445]
0
0
Izmir
Query!
Country [446]
0
0
Turkey
Query!
State/province [446]
0
0
Kayseri
Query!
Country [447]
0
0
Turkey
Query!
State/province [447]
0
0
Kocaeli
Query!
Country [448]
0
0
Turkey
Query!
State/province [448]
0
0
Malatya
Query!
Country [449]
0
0
Turkey
Query!
State/province [449]
0
0
Sivas
Query!
Country [450]
0
0
Ukraine
Query!
State/province [450]
0
0
Cherkasy
Query!
Country [451]
0
0
Ukraine
Query!
State/province [451]
0
0
Chernivtsi
Query!
Country [452]
0
0
Ukraine
Query!
State/province [452]
0
0
Dnipro
Query!
Country [453]
0
0
Ukraine
Query!
State/province [453]
0
0
Ivano-Frankivsk
Query!
Country [454]
0
0
Ukraine
Query!
State/province [454]
0
0
Kharkiv
Query!
Country [455]
0
0
Ukraine
Query!
State/province [455]
0
0
Kiev
Query!
Country [456]
0
0
Ukraine
Query!
State/province [456]
0
0
Kyiv
Query!
Country [457]
0
0
Ukraine
Query!
State/province [457]
0
0
Lviv
Query!
Country [458]
0
0
Ukraine
Query!
State/province [458]
0
0
Mykolayiv
Query!
Country [459]
0
0
Ukraine
Query!
State/province [459]
0
0
Ternopil
Query!
Country [460]
0
0
Ukraine
Query!
State/province [460]
0
0
Vinnytsia
Query!
Country [461]
0
0
Ukraine
Query!
State/province [461]
0
0
Zaporizhzhya
Query!
Country [462]
0
0
Ukraine
Query!
State/province [462]
0
0
Zaporozhye
Query!
Country [463]
0
0
United Kingdom
Query!
State/province [463]
0
0
Carmarthenshire
Query!
Country [464]
0
0
United Kingdom
Query!
State/province [464]
0
0
Merseyside
Query!
Country [465]
0
0
United Kingdom
Query!
State/province [465]
0
0
Northamptonshire
Query!
Country [466]
0
0
United Kingdom
Query!
State/province [466]
0
0
Surrey
Query!
Country [467]
0
0
United Kingdom
Query!
State/province [467]
0
0
West Midlands
Query!
Country [468]
0
0
United Kingdom
Query!
State/province [468]
0
0
West Sussex
Query!
Country [469]
0
0
United Kingdom
Query!
State/province [469]
0
0
Bristol
Query!
Country [470]
0
0
United Kingdom
Query!
State/province [470]
0
0
Glasgow
Query!
Country [471]
0
0
United Kingdom
Query!
State/province [471]
0
0
London
Query!
Country [472]
0
0
United Kingdom
Query!
State/province [472]
0
0
Manchester
Query!
Country [473]
0
0
United Kingdom
Query!
State/province [473]
0
0
Middlesborough
Query!
Country [474]
0
0
Vietnam
Query!
State/province [474]
0
0
Ha Noi
Query!
Country [475]
0
0
Vietnam
Query!
State/province [475]
0
0
Ho Chi Minh City
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bayer
Query!
Address
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Summary
Brief summary
The purpose of this study was 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.
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Trial website
https://clinicaltrials.gov/study/NCT02545049
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Trial related presentations / 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. Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28. Filippatos G, Anker SD, Pitt B, Rossing P, Joseph A, Kolkhof P, Lambelet M, Lawatscheck R, Bakris GL, Ruilope LM, Agarwal R. Finerenone and Heart Failure Outcomes by Kidney Function/Albuminuria in Chronic Kidney Disease and Diabetes. JACC Heart Fail. 2022 Nov;10(11):860-870. doi: 10.1016/j.jchf.2022.07.013. Epub 2022 Oct 12. Erratum In: JACC Heart Fail. 2023 Aug;11(8 Pt 1):1034-1035. doi: 10.1016/j.jchf.2023.06.002. Pitt B, Agarwal R, Anker SD, Ruilope LM, Rossing P, Ahlers C, Brinker M, Joseph A, Lambelet M, Lawatscheck R, Filippatos GS; FIDELIO-DKD and FIGARO-DKD Investigators. Association of Finerenone Use With Reduction in Treatment-Emergent Pneumonia and COVID-19 Adverse Events Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Pooled Secondary Analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123. Filippatos G, Anker SD, Agarwal R, Ruilope LM, Rossing P, Bakris GL, Tasto C, Joseph A, Kolkhof P, Lage A, Pitt B; FIGARO-DKD Investigators. Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial. Circulation. 2022 Feb 8;145(6):437-447. doi: 10.1161/CIRCULATIONAHA.121.057983. Epub 2021 Nov 13. Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish. Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022 May 25;37(6):1014-1023. doi: 10.1093/ndt/gfaa294.
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Public notes
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Contacts
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Bayer Study Director
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Bayer
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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What supporting documents are/will be available?
No Supporting Document Provided
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Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/49/NCT02545049/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/49/NCT02545049/SAP_001.pdf
Results publications and other study-related documents
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Citations or Other Details
Journal
Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filipp...
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Journal
Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris ...
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Results not provided in
https://clinicaltrials.gov/study/NCT02545049