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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02065791
Registration number
NCT02065791
Ethics application status
Date submitted
17/02/2014
Date registered
19/02/2014
Date last updated
5/12/2019
Titles & IDs
Public title
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
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Scientific title
A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
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Secondary ID [1]
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2013-004494-28
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Secondary ID [2]
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CR103517
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Universal Trial Number (UTN)
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Trial acronym
CREDENCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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0
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Diabetic Nephropathy
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Metabolic and Endocrine
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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 - Canagliflozin
Treatment: Drugs - Placebo
Experimental: Canagliflozin 100 mg - Each participant will receive 100 mg of canagliflozin once daily
Placebo comparator: Placebo - Each participant will receive matching placebo once daily
Treatment: Drugs: Canagliflozin
One 100 mg over-encapsulated tablet orally once daily
Treatment: Drugs: Placebo
One matching placebo capsule orally (by mouth) 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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Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death
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Assessment method [1]
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Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (\<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented.
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Timepoint [1]
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Up to 4.6 years
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Secondary outcome [1]
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Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)
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Assessment method [1]
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The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented.
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Timepoint [1]
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Up to 4.6 years
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Secondary outcome [2]
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Major Adverse Cardiac Event (MACE)
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Assessment method [2]
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The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
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Timepoint [2]
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Up to 4.6 years
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Secondary outcome [3]
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Hospitalized Heart Failure (HHF)
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Assessment method [3]
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Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented.
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Timepoint [3]
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Up to 4.6 years
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Secondary outcome [4]
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Renal Composite Endpoint
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Assessment method [4]
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The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of \<15 mL/min/1.73 m\^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.
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Timepoint [4]
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Up to 4.6 years
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Secondary outcome [5]
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Cardiovascular (CV) Death
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Assessment method [5]
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CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented.
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Timepoint [5]
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Up to 4.6 years
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Secondary outcome [6]
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All-cause Mortality
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Assessment method [6]
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Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented.
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Timepoint [6]
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Up to 4.6 years
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Secondary outcome [7]
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CV Composite Endpoint
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Assessment method [7]
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The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented.
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Timepoint [7]
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Up to 4.6 years
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Eligibility
Key inclusion criteria
* Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=) 6.5 percent (%) and less than or equal to (<=) 12.0%, with an estimated glomerular filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less than (<) 90 mL/min/1.73 m^2
* Participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to randomization
* Must have a urine albumin to creatinine ratio (UACR) of greater than (>) 300 milligram (mg)/gram (g) and <= 5000 mg/g
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Minimum age
30
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
* History of diabetic ketoacidosis or type 1 diabetes mellitus
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
* Renal disease that required treatment with immunosuppressive therapy
* Known significant liver disease
* Current or history of New York Heart Association (NYHA) Class IV heart failure
* Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening
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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 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
17/02/2014
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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
30/10/2018
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Sample size
Target
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Accrual to date
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Final
4401
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Recruitment in Australia
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- Cairns
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- Concord
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- Darlinghurst
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- Elizabeth Vale
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- Heidelberg
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- Elizabeth Vale
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- Sydney
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Recruitment postcode(s) [16]
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- Woolloongabba
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Recruitment outside Australia
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0
0
Bulgaria
Query!
State/province [97]
0
0
Plovdiv
Query!
Country [98]
0
0
Bulgaria
Query!
State/province [98]
0
0
Sofia
Query!
Country [99]
0
0
Bulgaria
Query!
State/province [99]
0
0
Varna
Query!
Country [100]
0
0
Canada
Query!
State/province [100]
0
0
Alberta
Query!
Country [101]
0
0
Canada
Query!
State/province [101]
0
0
British Columbia
Query!
Country [102]
0
0
Canada
Query!
State/province [102]
0
0
Manitoba
Query!
Country [103]
0
0
Canada
Query!
State/province [103]
0
0
Ontario
Query!
Country [104]
0
0
Canada
Query!
State/province [104]
0
0
Quebec
Query!
Country [105]
0
0
Canada
Query!
State/province [105]
0
0
Québec
Query!
Country [106]
0
0
Canada
Query!
State/province [106]
0
0
Toronto
Query!
Country [107]
0
0
Canada
Query!
State/province [107]
0
0
Vancouver
Query!
Country [108]
0
0
Chile
Query!
State/province [108]
0
0
Concepcion
Query!
Country [109]
0
0
Chile
Query!
State/province [109]
0
0
Santiago
Query!
Country [110]
0
0
Chile
Query!
State/province [110]
0
0
Temuco
Query!
Country [111]
0
0
China
Query!
State/province [111]
0
0
Beijing
Query!
Country [112]
0
0
China
Query!
State/province [112]
0
0
Changchun
Query!
Country [113]
0
0
China
Query!
State/province [113]
0
0
Changde
Query!
Country [114]
0
0
China
Query!
State/province [114]
0
0
Changsha
Query!
Country [115]
0
0
China
Query!
State/province [115]
0
0
Chengdu
Query!
Country [116]
0
0
China
Query!
State/province [116]
0
0
Chenzhou
Query!
Country [117]
0
0
China
Query!
State/province [117]
0
0
Dalian
Query!
Country [118]
0
0
China
Query!
State/province [118]
0
0
Foshan
Query!
Country [119]
0
0
China
Query!
State/province [119]
0
0
Guangzhou
Query!
Country [120]
0
0
China
Query!
State/province [120]
0
0
Huai'an
Query!
Country [121]
0
0
China
Query!
State/province [121]
0
0
Nanchang
Query!
Country [122]
0
0
China
Query!
State/province [122]
0
0
Nanjing
Query!
Country [123]
0
0
China
Query!
State/province [123]
0
0
Shanghai
Query!
Country [124]
0
0
China
Query!
State/province [124]
0
0
Shenyang
Query!
Country [125]
0
0
China
Query!
State/province [125]
0
0
Wuhan
Query!
Country [126]
0
0
China
Query!
State/province [126]
0
0
Wulumuqi
Query!
Country [127]
0
0
China
Query!
State/province [127]
0
0
Xian
Query!
Country [128]
0
0
Colombia
Query!
State/province [128]
0
0
Barranquilla
Query!
Country [129]
0
0
Colombia
Query!
State/province [129]
0
0
Bogota
Query!
Country [130]
0
0
Colombia
Query!
State/province [130]
0
0
Bucaramanga
Query!
Country [131]
0
0
Colombia
Query!
State/province [131]
0
0
Cali
Query!
Country [132]
0
0
Colombia
Query!
State/province [132]
0
0
Floridablanca
Query!
Country [133]
0
0
Colombia
Query!
State/province [133]
0
0
Manizales
Query!
Country [134]
0
0
Colombia
Query!
State/province [134]
0
0
Medellin
Query!
Country [135]
0
0
Colombia
Query!
State/province [135]
0
0
Pasto
Query!
Country [136]
0
0
Colombia
Query!
State/province [136]
0
0
Pereira
Query!
Country [137]
0
0
Czechia
Query!
State/province [137]
0
0
Ceske Budejovice
Query!
Country [138]
0
0
Czechia
Query!
State/province [138]
0
0
Cesky Krumlov
Query!
Country [139]
0
0
Czechia
Query!
State/province [139]
0
0
Chocen
Query!
Country [140]
0
0
Czechia
Query!
State/province [140]
0
0
Havlickuv Brod
Query!
Country [141]
0
0
Czechia
Query!
State/province [141]
0
0
Hradec Kralove-Vekose
Query!
Country [142]
0
0
Czechia
Query!
State/province [142]
0
0
Hradec Nad Svitavou
Query!
Country [143]
0
0
Czechia
Query!
State/province [143]
0
0
Jindrichuv Hradec
Query!
Country [144]
0
0
Czechia
Query!
State/province [144]
0
0
Olomouc
Query!
Country [145]
0
0
Czechia
Query!
State/province [145]
0
0
Praha 10
Query!
Country [146]
0
0
Czechia
Query!
State/province [146]
0
0
Praha 2
Query!
Country [147]
0
0
Czechia
Query!
State/province [147]
0
0
Praha 4
Query!
Country [148]
0
0
Czechia
Query!
State/province [148]
0
0
Praha 5
Query!
Country [149]
0
0
Czechia
Query!
State/province [149]
0
0
Praha
Query!
Country [150]
0
0
Czechia
Query!
State/province [150]
0
0
Slany
Query!
Country [151]
0
0
Czechia
Query!
State/province [151]
0
0
Trutnov
Query!
Country [152]
0
0
Czechia
Query!
State/province [152]
0
0
Uherske Hradiste
Query!
Country [153]
0
0
Czechia
Query!
State/province [153]
0
0
Usti Nad Labem
Query!
Country [154]
0
0
France
Query!
State/province [154]
0
0
Besancon Cedex
Query!
Country [155]
0
0
France
Query!
State/province [155]
0
0
Brest cedex
Query!
Country [156]
0
0
France
Query!
State/province [156]
0
0
Colmar N/a
Query!
Country [157]
0
0
France
Query!
State/province [157]
0
0
Corbeil Essonnes Cedex
Query!
Country [158]
0
0
France
Query!
State/province [158]
0
0
Créteil Cedex
Query!
Country [159]
0
0
France
Query!
State/province [159]
0
0
Grenoble
Query!
Country [160]
0
0
France
Query!
State/province [160]
0
0
Lyon cedex 03
Query!
Country [161]
0
0
France
Query!
State/province [161]
0
0
Marseille Cedex 05
Query!
Country [162]
0
0
France
Query!
State/province [162]
0
0
Metz cedex 03
Query!
Country [163]
0
0
France
Query!
State/province [163]
0
0
Nantes Cedex 01
Query!
Country [164]
0
0
France
Query!
State/province [164]
0
0
Paris Cedex 15
Query!
Country [165]
0
0
France
Query!
State/province [165]
0
0
Paris Cedex 18
Query!
Country [166]
0
0
France
Query!
State/province [166]
0
0
Paris
Query!
Country [167]
0
0
France
Query!
State/province [167]
0
0
Pierre-Bénit
Query!
Country [168]
0
0
France
Query!
State/province [168]
0
0
Poitiers
Query!
Country [169]
0
0
France
Query!
State/province [169]
0
0
St Priest-en-Jarez
Query!
Country [170]
0
0
France
Query!
State/province [170]
0
0
Strasbourg
Query!
Country [171]
0
0
France
Query!
State/province [171]
0
0
Toulouse Cedex 9
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Bad Kreuznach - Bosenheim
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Dietzenbach
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Dresden
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Essen
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Hamburg
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Hannover
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Köln
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Muenster
Query!
Country [180]
0
0
Guatemala
Query!
State/province [180]
0
0
Guatemala City
Query!
Country [181]
0
0
Guatemala
Query!
State/province [181]
0
0
Guatemala
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Baja
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Balatonfured
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Budapest
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Debrecen
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Eger
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Esztergom
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Godollo
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Gyula
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Hu-4012 Debrecen N/a
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Kaposvar
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Kecskemet N/a
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Komarom
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Nyiregyhaza
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Pecs
Query!
Country [196]
0
0
Hungary
Query!
State/province [196]
0
0
Szeged N/a
Query!
Country [197]
0
0
Hungary
Query!
State/province [197]
0
0
Szigetvar
Query!
Country [198]
0
0
Hungary
Query!
State/province [198]
0
0
Veszprem
Query!
Country [199]
0
0
Hungary
Query!
State/province [199]
0
0
Zalaegerszeg
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Calicut
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Chennai
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Delhi
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Hyderabad
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Kozhikode
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Lucknow
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Ludhiyana
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Mangalore
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
Mumbai
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Mysore
Query!
Country [210]
0
0
India
Query!
State/province [210]
0
0
Secunderabad
Query!
Country [211]
0
0
India
Query!
State/province [211]
0
0
Trivandrum
Query!
Country [212]
0
0
India
Query!
State/province [212]
0
0
Vijayawada
Query!
Country [213]
0
0
India
Query!
State/province [213]
0
0
Vishakhapatnam
Query!
Country [214]
0
0
Japan
Query!
State/province [214]
0
0
Ageo-shi
Query!
Country [215]
0
0
Japan
Query!
State/province [215]
0
0
Chiyoda-ku
Query!
Country [216]
0
0
Japan
Query!
State/province [216]
0
0
Fukuoka
Query!
Country [217]
0
0
Japan
Query!
State/province [217]
0
0
Hamamatsu-shi
Query!
Country [218]
0
0
Japan
Query!
State/province [218]
0
0
Hamura-shi
Query!
Country [219]
0
0
Japan
Query!
State/province [219]
0
0
Ina-shi
Query!
Country [220]
0
0
Japan
Query!
State/province [220]
0
0
Izumisano
Query!
Country [221]
0
0
Japan
Query!
State/province [221]
0
0
Kamakura-shi
Query!
Country [222]
0
0
Japan
Query!
State/province [222]
0
0
Kanazawa
Query!
Country [223]
0
0
Japan
Query!
State/province [223]
0
0
Kawanishi-shi
Query!
Country [224]
0
0
Japan
Query!
State/province [224]
0
0
Koriyama-shi
Query!
Country [225]
0
0
Japan
Query!
State/province [225]
0
0
Kuki-shi
Query!
Country [226]
0
0
Japan
Query!
State/province [226]
0
0
Kyoto
Query!
Country [227]
0
0
Japan
Query!
State/province [227]
0
0
Matsuyama-shi
Query!
Country [228]
0
0
Japan
Query!
State/province [228]
0
0
Midori-shi
Query!
Country [229]
0
0
Japan
Query!
State/province [229]
0
0
Minato-ku
Query!
Country [230]
0
0
Japan
Query!
State/province [230]
0
0
Nagoya-shi
Query!
Country [231]
0
0
Japan
Query!
State/province [231]
0
0
Osaka-shi
Query!
Country [232]
0
0
Japan
Query!
State/province [232]
0
0
Ota-shi
Query!
Country [233]
0
0
Japan
Query!
State/province [233]
0
0
Saiki-shi
Query!
Country [234]
0
0
Japan
Query!
State/province [234]
0
0
Sashima-gun
Query!
Country [235]
0
0
Japan
Query!
State/province [235]
0
0
Shinjuku-ku
Query!
Country [236]
0
0
Japan
Query!
State/province [236]
0
0
Toyama-shi
Query!
Country [237]
0
0
Japan
Query!
State/province [237]
0
0
Uwajima-shi
Query!
Country [238]
0
0
Japan
Query!
State/province [238]
0
0
Yamanashi
Query!
Country [239]
0
0
Japan
Query!
State/province [239]
0
0
Yokohama-City
Query!
Country [240]
0
0
Japan
Query!
State/province [240]
0
0
Yokohama-shi
Query!
Country [241]
0
0
Korea, Republic of
Query!
State/province [241]
0
0
Busan
Query!
Country [242]
0
0
Korea, Republic of
Query!
State/province [242]
0
0
Daegu
Query!
Country [243]
0
0
Korea, Republic of
Query!
State/province [243]
0
0
Incheon
Query!
Country [244]
0
0
Korea, Republic of
Query!
State/province [244]
0
0
Seongnam
Query!
Country [245]
0
0
Korea, Republic of
Query!
State/province [245]
0
0
Seoul
Query!
Country [246]
0
0
Lithuania
Query!
State/province [246]
0
0
Kaunas
Query!
Country [247]
0
0
Lithuania
Query!
State/province [247]
0
0
Klaipeda
Query!
Country [248]
0
0
Lithuania
Query!
State/province [248]
0
0
Siauliai
Query!
Country [249]
0
0
Malaysia
Query!
State/province [249]
0
0
Batu Caves
Query!
Country [250]
0
0
Malaysia
Query!
State/province [250]
0
0
Ipoh
Query!
Country [251]
0
0
Malaysia
Query!
State/province [251]
0
0
Johor
Query!
Country [252]
0
0
Malaysia
Query!
State/province [252]
0
0
Kuala Lumpur N/a
Query!
Country [253]
0
0
Malaysia
Query!
State/province [253]
0
0
Kuala Lumpur
Query!
Country [254]
0
0
Malaysia
Query!
State/province [254]
0
0
Kuantan
Query!
Country [255]
0
0
Malaysia
Query!
State/province [255]
0
0
Melaka
Query!
Country [256]
0
0
Malaysia
Query!
State/province [256]
0
0
Perai
Query!
Country [257]
0
0
Malaysia
Query!
State/province [257]
0
0
Petaling Jaya
Query!
Country [258]
0
0
Malaysia
Query!
State/province [258]
0
0
Seremban
Query!
Country [259]
0
0
Malaysia
Query!
State/province [259]
0
0
Seri Manjung
Query!
Country [260]
0
0
Malaysia
Query!
State/province [260]
0
0
Sungai Petani, Kedah
Query!
Country [261]
0
0
Malaysia
Query!
State/province [261]
0
0
Tampin
Query!
Country [262]
0
0
Malaysia
Query!
State/province [262]
0
0
Temerloh
Query!
Country [263]
0
0
Mexico
Query!
State/province [263]
0
0
Aguascalientes
Query!
Country [264]
0
0
Mexico
Query!
State/province [264]
0
0
Celaya
Query!
Country [265]
0
0
Mexico
Query!
State/province [265]
0
0
Chihuahua
Query!
Country [266]
0
0
Mexico
Query!
State/province [266]
0
0
Ciudad De Mexico
Query!
Country [267]
0
0
Mexico
Query!
State/province [267]
0
0
Ciudad De Mexic
Query!
Country [268]
0
0
Mexico
Query!
State/province [268]
0
0
Cuautitlan Izcalli
Query!
Country [269]
0
0
Mexico
Query!
State/province [269]
0
0
Culiacan
Query!
Country [270]
0
0
Mexico
Query!
State/province [270]
0
0
Culiacán
Query!
Country [271]
0
0
Mexico
Query!
State/province [271]
0
0
Durango
Query!
Country [272]
0
0
Mexico
Query!
State/province [272]
0
0
El Salto
Query!
Country [273]
0
0
Mexico
Query!
State/province [273]
0
0
Guadalajara
Query!
Country [274]
0
0
Mexico
Query!
State/province [274]
0
0
Leon
Query!
Country [275]
0
0
Mexico
Query!
State/province [275]
0
0
Merida
Query!
Country [276]
0
0
Mexico
Query!
State/province [276]
0
0
Mexico City
Query!
Country [277]
0
0
Mexico
Query!
State/province [277]
0
0
Mexico
Query!
Country [278]
0
0
Mexico
Query!
State/province [278]
0
0
Monterrey
Query!
Country [279]
0
0
Mexico
Query!
State/province [279]
0
0
Morelia
Query!
Country [280]
0
0
Mexico
Query!
State/province [280]
0
0
Orizaba
Query!
Country [281]
0
0
Mexico
Query!
State/province [281]
0
0
Pachuca de Soto
Query!
Country [282]
0
0
Mexico
Query!
State/province [282]
0
0
Pachuca
Query!
Country [283]
0
0
Mexico
Query!
State/province [283]
0
0
Queretaro
Query!
Country [284]
0
0
Mexico
Query!
State/province [284]
0
0
San Luis Potosi
Query!
Country [285]
0
0
Mexico
Query!
State/province [285]
0
0
Tlalnepantla de Baz
Query!
Country [286]
0
0
Mexico
Query!
State/province [286]
0
0
Veracruz
Query!
Country [287]
0
0
Mexico
Query!
State/province [287]
0
0
Zapopan
Query!
Country [288]
0
0
New Zealand
Query!
State/province [288]
0
0
Auckland
Query!
Country [289]
0
0
New Zealand
Query!
State/province [289]
0
0
Christchurch
Query!
Country [290]
0
0
New Zealand
Query!
State/province [290]
0
0
Dunedin
Query!
Country [291]
0
0
New Zealand
Query!
State/province [291]
0
0
Palmerston North
Query!
Country [292]
0
0
New Zealand
Query!
State/province [292]
0
0
Rotorua
Query!
Country [293]
0
0
New Zealand
Query!
State/province [293]
0
0
Takapuna Auckland
Query!
Country [294]
0
0
New Zealand
Query!
State/province [294]
0
0
Tauranga
Query!
Country [295]
0
0
New Zealand
Query!
State/province [295]
0
0
Wellington
Query!
Country [296]
0
0
Philippines
Query!
State/province [296]
0
0
Cagayan De Oro City
Query!
Country [297]
0
0
Philippines
Query!
State/province [297]
0
0
Cebuu City
Query!
Country [298]
0
0
Philippines
Query!
State/province [298]
0
0
Cebu
Query!
Country [299]
0
0
Philippines
Query!
State/province [299]
0
0
Davao City
Query!
Country [300]
0
0
Philippines
Query!
State/province [300]
0
0
Iloilo City
Query!
Country [301]
0
0
Philippines
Query!
State/province [301]
0
0
Lipa City
Query!
Country [302]
0
0
Philippines
Query!
State/province [302]
0
0
Marikina City
Query!
Country [303]
0
0
Philippines
Query!
State/province [303]
0
0
Pasay City
Query!
Country [304]
0
0
Philippines
Query!
State/province [304]
0
0
Pasig
Query!
Country [305]
0
0
Philippines
Query!
State/province [305]
0
0
Quezon City
Query!
Country [306]
0
0
Philippines
Query!
State/province [306]
0
0
San Fernando
Query!
Country [307]
0
0
Philippines
Query!
State/province [307]
0
0
Tagbilaran City
Query!
Country [308]
0
0
Philippines
Query!
State/province [308]
0
0
Taytay
Query!
Country [309]
0
0
Poland
Query!
State/province [309]
0
0
Bydgoszcz
Query!
Country [310]
0
0
Poland
Query!
State/province [310]
0
0
Chorzow
Query!
Country [311]
0
0
Poland
Query!
State/province [311]
0
0
Katowice
Query!
Country [312]
0
0
Poland
Query!
State/province [312]
0
0
Krakow
Query!
Country [313]
0
0
Poland
Query!
State/province [313]
0
0
Lodz
Query!
Country [314]
0
0
Poland
Query!
State/province [314]
0
0
Lublin
Query!
Country [315]
0
0
Poland
Query!
State/province [315]
0
0
Parczew
Query!
Country [316]
0
0
Poland
Query!
State/province [316]
0
0
Poznan
Query!
Country [317]
0
0
Poland
Query!
State/province [317]
0
0
Radom
Query!
Country [318]
0
0
Poland
Query!
State/province [318]
0
0
Rzeszow
Query!
Country [319]
0
0
Poland
Query!
State/province [319]
0
0
Torun
Query!
Country [320]
0
0
Poland
Query!
State/province [320]
0
0
Warswa
Query!
Country [321]
0
0
Poland
Query!
State/province [321]
0
0
Wroclaw
Query!
Country [322]
0
0
Poland
Query!
State/province [322]
0
0
Zgierz
Query!
Country [323]
0
0
Poland
Query!
State/province [323]
0
0
Znin
Query!
Country [324]
0
0
Puerto Rico
Query!
State/province [324]
0
0
Caguas
Query!
Country [325]
0
0
Puerto Rico
Query!
State/province [325]
0
0
Ponce
Query!
Country [326]
0
0
Puerto Rico
Query!
State/province [326]
0
0
San Juan
Query!
Country [327]
0
0
Romania
Query!
State/province [327]
0
0
Brasov
Query!
Country [328]
0
0
Romania
Query!
State/province [328]
0
0
Bucuresti
Query!
Country [329]
0
0
Romania
Query!
State/province [329]
0
0
Cluj Napoca
Query!
Country [330]
0
0
Romania
Query!
State/province [330]
0
0
Deva
Query!
Country [331]
0
0
Romania
Query!
State/province [331]
0
0
Iasi
Query!
Country [332]
0
0
Romania
Query!
State/province [332]
0
0
Oradea
Query!
Country [333]
0
0
Romania
Query!
State/province [333]
0
0
Ploiesti
Query!
Country [334]
0
0
Romania
Query!
State/province [334]
0
0
Targu Mures
Query!
Country [335]
0
0
Romania
Query!
State/province [335]
0
0
Timisoara
Query!
Country [336]
0
0
Russian Federation
Query!
State/province [336]
0
0
Arkhangelsk
Query!
Country [337]
0
0
Russian Federation
Query!
State/province [337]
0
0
Barnaul
Query!
Country [338]
0
0
Russian Federation
Query!
State/province [338]
0
0
Ivanovo
Query!
Country [339]
0
0
Russian Federation
Query!
State/province [339]
0
0
Kemerovo
Query!
Country [340]
0
0
Russian Federation
Query!
State/province [340]
0
0
Moscow
Query!
Country [341]
0
0
Russian Federation
Query!
State/province [341]
0
0
Novosibirsk
Query!
Country [342]
0
0
Russian Federation
Query!
State/province [342]
0
0
Petrozavodsk
Query!
Country [343]
0
0
Russian Federation
Query!
State/province [343]
0
0
Rostov-on-Don
Query!
Country [344]
0
0
Russian Federation
Query!
State/province [344]
0
0
Ryazan
Query!
Country [345]
0
0
Russian Federation
Query!
State/province [345]
0
0
Saint Petersburg
Query!
Country [346]
0
0
Russian Federation
Query!
State/province [346]
0
0
Saint-Petersburg
Query!
Country [347]
0
0
Russian Federation
Query!
State/province [347]
0
0
Saratov
Query!
Country [348]
0
0
Russian Federation
Query!
State/province [348]
0
0
Sestroretsk, Saint-Petersburg
Query!
Country [349]
0
0
Russian Federation
Query!
State/province [349]
0
0
St. Petersburg
Query!
Country [350]
0
0
Russian Federation
Query!
State/province [350]
0
0
Tomsk
Query!
Country [351]
0
0
Russian Federation
Query!
State/province [351]
0
0
Ufa
Query!
Country [352]
0
0
Russian Federation
Query!
State/province [352]
0
0
Volgograd
Query!
Country [353]
0
0
Russian Federation
Query!
State/province [353]
0
0
Yaroslavl
Query!
Country [354]
0
0
Serbia
Query!
State/province [354]
0
0
Belgrade
Query!
Country [355]
0
0
Serbia
Query!
State/province [355]
0
0
Nis
Query!
Country [356]
0
0
Serbia
Query!
State/province [356]
0
0
Zajecar
Query!
Country [357]
0
0
Slovakia
Query!
State/province [357]
0
0
Bardejov
Query!
Country [358]
0
0
Slovakia
Query!
State/province [358]
0
0
Bratislava
Query!
Country [359]
0
0
Slovakia
Query!
State/province [359]
0
0
Kosice
Query!
Country [360]
0
0
Slovakia
Query!
State/province [360]
0
0
Lubochna
Query!
Country [361]
0
0
Slovakia
Query!
State/province [361]
0
0
Nitra
Query!
Country [362]
0
0
Slovakia
Query!
State/province [362]
0
0
Prievidza
Query!
Country [363]
0
0
Slovakia
Query!
State/province [363]
0
0
Puchov
Query!
Country [364]
0
0
Slovakia
Query!
State/province [364]
0
0
Rimavska Sobota
Query!
Country [365]
0
0
Slovakia
Query!
State/province [365]
0
0
Sturovo
Query!
Country [366]
0
0
Slovakia
Query!
State/province [366]
0
0
Svidnik
Query!
Country [367]
0
0
Slovakia
Query!
State/province [367]
0
0
Zilina
Query!
Country [368]
0
0
South Africa
Query!
State/province [368]
0
0
Cape Town
Query!
Country [369]
0
0
South Africa
Query!
State/province [369]
0
0
Durban
Query!
Country [370]
0
0
South Africa
Query!
State/province [370]
0
0
Isipingo Rail
Query!
Country [371]
0
0
South Africa
Query!
State/province [371]
0
0
Johannesburg
Query!
Country [372]
0
0
South Africa
Query!
State/province [372]
0
0
Krugersdorp
Query!
Country [373]
0
0
South Africa
Query!
State/province [373]
0
0
Port Elizabeth
Query!
Country [374]
0
0
South Africa
Query!
State/province [374]
0
0
Pretoria Gauteng
Query!
Country [375]
0
0
South Africa
Query!
State/province [375]
0
0
Pretoria
Query!
Country [376]
0
0
South Africa
Query!
State/province [376]
0
0
Soweto
Query!
Country [377]
0
0
Spain
Query!
State/province [377]
0
0
A Coruna
Query!
Country [378]
0
0
Spain
Query!
State/province [378]
0
0
Almeria
Query!
Country [379]
0
0
Spain
Query!
State/province [379]
0
0
Barcelona
Query!
Country [380]
0
0
Spain
Query!
State/province [380]
0
0
Burela
Query!
Country [381]
0
0
Spain
Query!
State/province [381]
0
0
Ciudad Real
Query!
Country [382]
0
0
Spain
Query!
State/province [382]
0
0
Getafe
Query!
Country [383]
0
0
Spain
Query!
State/province [383]
0
0
Girona
Query!
Country [384]
0
0
Spain
Query!
State/province [384]
0
0
Granada
Query!
Country [385]
0
0
Spain
Query!
State/province [385]
0
0
La Roca del Vallès
Query!
Country [386]
0
0
Spain
Query!
State/province [386]
0
0
Madrid
Query!
Country [387]
0
0
Spain
Query!
State/province [387]
0
0
Majadahonda
Query!
Country [388]
0
0
Spain
Query!
State/province [388]
0
0
Málaga
Query!
Country [389]
0
0
Spain
Query!
State/province [389]
0
0
Palma de Mallorca
Query!
Country [390]
0
0
Spain
Query!
State/province [390]
0
0
Pozuelo de Alarcón
Query!
Country [391]
0
0
Spain
Query!
State/province [391]
0
0
Sagunto
Query!
Country [392]
0
0
Spain
Query!
State/province [392]
0
0
Santander
Query!
Country [393]
0
0
Spain
Query!
State/province [393]
0
0
Sevilla
Query!
Country [394]
0
0
Spain
Query!
State/province [394]
0
0
Valencia
Query!
Country [395]
0
0
Spain
Query!
State/province [395]
0
0
Vic
Query!
Country [396]
0
0
Spain
Query!
State/province [396]
0
0
Viladecans
Query!
Country [397]
0
0
Taiwan
Query!
State/province [397]
0
0
Kaohsiung
Query!
Country [398]
0
0
Taiwan
Query!
State/province [398]
0
0
New Taipei City
Query!
Country [399]
0
0
Taiwan
Query!
State/province [399]
0
0
Taichung
Query!
Country [400]
0
0
Taiwan
Query!
State/province [400]
0
0
Taipei
Query!
Country [401]
0
0
Ukraine
Query!
State/province [401]
0
0
Chernivtsi
Query!
Country [402]
0
0
Ukraine
Query!
State/province [402]
0
0
Dnipropetrovsk
Query!
Country [403]
0
0
Ukraine
Query!
State/province [403]
0
0
Ivano-Frankivsk
Query!
Country [404]
0
0
Ukraine
Query!
State/province [404]
0
0
Kharkiv
Query!
Country [405]
0
0
Ukraine
Query!
State/province [405]
0
0
Kiev
Query!
Country [406]
0
0
Ukraine
Query!
State/province [406]
0
0
Kyiv
Query!
Country [407]
0
0
Ukraine
Query!
State/province [407]
0
0
Ternopil
Query!
Country [408]
0
0
Ukraine
Query!
State/province [408]
0
0
Vinnitsya
Query!
Country [409]
0
0
Ukraine
Query!
State/province [409]
0
0
Vinnytsia
Query!
Country [410]
0
0
Ukraine
Query!
State/province [410]
0
0
Zaporizhzhia
Query!
Country [411]
0
0
United Arab Emirates
Query!
State/province [411]
0
0
Ajman
Query!
Country [412]
0
0
United Arab Emirates
Query!
State/province [412]
0
0
Dubai
Query!
Country [413]
0
0
United Arab Emirates
Query!
State/province [413]
0
0
Sharjah
Query!
Country [414]
0
0
United Kingdom
Query!
State/province [414]
0
0
Aberdeen
Query!
Country [415]
0
0
United Kingdom
Query!
State/province [415]
0
0
Antrim
Query!
Country [416]
0
0
United Kingdom
Query!
State/province [416]
0
0
Barry
Query!
Country [417]
0
0
United Kingdom
Query!
State/province [417]
0
0
Birmingham
Query!
Country [418]
0
0
United Kingdom
Query!
State/province [418]
0
0
Blackburn
Query!
Country [419]
0
0
United Kingdom
Query!
State/province [419]
0
0
Bolton
Query!
Country [420]
0
0
United Kingdom
Query!
State/province [420]
0
0
Bournemouth
Query!
Country [421]
0
0
United Kingdom
Query!
State/province [421]
0
0
Bradford
Query!
Country [422]
0
0
United Kingdom
Query!
State/province [422]
0
0
Bristol
Query!
Country [423]
0
0
United Kingdom
Query!
State/province [423]
0
0
Burbage
Query!
Country [424]
0
0
United Kingdom
Query!
State/province [424]
0
0
Cardff
Query!
Country [425]
0
0
United Kingdom
Query!
State/province [425]
0
0
Cardiff
Query!
Country [426]
0
0
United Kingdom
Query!
State/province [426]
0
0
Carlshalton
Query!
Country [427]
0
0
United Kingdom
Query!
State/province [427]
0
0
Carmarthen
Query!
Country [428]
0
0
United Kingdom
Query!
State/province [428]
0
0
Chester
Query!
Country [429]
0
0
United Kingdom
Query!
State/province [429]
0
0
Darlington
Query!
Country [430]
0
0
United Kingdom
Query!
State/province [430]
0
0
Doncaster
Query!
Country [431]
0
0
United Kingdom
Query!
State/province [431]
0
0
Durham
Query!
Country [432]
0
0
United Kingdom
Query!
State/province [432]
0
0
Ely
Query!
Country [433]
0
0
United Kingdom
Query!
State/province [433]
0
0
Hampstead
Query!
Country [434]
0
0
United Kingdom
Query!
State/province [434]
0
0
Harlow
Query!
Country [435]
0
0
United Kingdom
Query!
State/province [435]
0
0
Huntingdon
Query!
Country [436]
0
0
United Kingdom
Query!
State/province [436]
0
0
Leamington Spa
Query!
Country [437]
0
0
United Kingdom
Query!
State/province [437]
0
0
Liskeard
Query!
Country [438]
0
0
United Kingdom
Query!
State/province [438]
0
0
London
Query!
Country [439]
0
0
United Kingdom
Query!
State/province [439]
0
0
Middlesbrough
Query!
Country [440]
0
0
United Kingdom
Query!
State/province [440]
0
0
Plymouth
Query!
Country [441]
0
0
United Kingdom
Query!
State/province [441]
0
0
Rhyl
Query!
Country [442]
0
0
United Kingdom
Query!
State/province [442]
0
0
Rugby
Query!
Country [443]
0
0
United Kingdom
Query!
State/province [443]
0
0
Salford
Query!
Country [444]
0
0
United Kingdom
Query!
State/province [444]
0
0
Stoke On Trent
Query!
Country [445]
0
0
United Kingdom
Query!
State/province [445]
0
0
Swansea
Query!
Country [446]
0
0
United Kingdom
Query!
State/province [446]
0
0
Torpoint
Query!
Country [447]
0
0
United Kingdom
Query!
State/province [447]
0
0
Watford
Query!
Country [448]
0
0
United Kingdom
Query!
State/province [448]
0
0
Welwyn Garden City
Query!
Country [449]
0
0
United Kingdom
Query!
State/province [449]
0
0
Westcliff on Sea
Query!
Country [450]
0
0
United Kingdom
Query!
State/province [450]
0
0
Wokingham
Query!
Country [451]
0
0
United Kingdom
Query!
State/province [451]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Janssen Research & Development, LLC
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Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
The George Institute for Global Health, Australia
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
Query!
Trial website
https://clinicaltrials.gov/study/NCT02065791
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Trial related presentations / publications
Sarraju A, Bakris G, Cannon CP, Cherney D, Damaraju CV, Figtree GA, Gogate J, Greene T, Heerspink HJL, Januzzi JL Jr, Neal B, Jardine MJ, Blais J, Kosiborod M, Levin A, Lingvay I, Weir MR, Perkovic V, Mahaffey KW. Cardiovascular Effects of Canagliflozin in Relation to Renal Function and Albuminuria. J Am Coll Cardiol. 2022 Nov 1;80(18):1721-1731. doi: 10.1016/j.jacc.2022.08.772. Li JW, Arnott C, Heerspink HJL, MBiostat QL, Cannon CP, Wheeler DC, Charytan DM, Barraclough J, Figtree GA, Agarwal R, Bakris G, de Zeeuw D, Greene T, Levin A, Pollock C, Zhang H, Zinman B, Mahaffey KW, Perkovic V, Neal B, Jardine MJ. Effect of Canagliflozin on Total Cardiovascular Burden in Patients With Diabetes and Chronic Kidney Disease: A Post Hoc Analysis From the CREDENCE Trial. J Am Heart Assoc. 2022 Aug 16;11(16):e025045. doi: 10.1161/JAHA.121.025045. Epub 2022 Aug 5. Charytan DM, Yu J, Jardine MJ, Cannon CP, Agarwal R, Bakris G, Greene T, Levin A, Pollock C, Powe NR, Arnott C, Mahaffey KW; CREDENCE study investigators. Potential Effects of Elimination of the Black Race Coefficient in eGFR Calculations in the CREDENCE Trial. Clin J Am Soc Nephrol. 2022 Mar;17(3):361-373. doi: 10.2215/CJN.08980621. Epub 2022 Jan 21. Heerspink HJL, Oshima M, Zhang H, Li J, Agarwal R, Capuano G, Charytan DM, Craig J, de Zeeuw D, Di Tanna GL, Levin A, Neal B, Perkovic V, Wheeler DC, Yavin Y, Jardine MJ. Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial. Am J Kidney Dis. 2022 Feb;79(2):244-256.e1. doi: 10.1053/j.ajkd.2021.05.005. Epub 2021 May 23. Zhou Z, Jardine MJ, Li Q, Neuen BL, Cannon CP, de Zeeuw D, Edwards R, Levin A, Mahaffey KW, Perkovic V, Neal B, Lindley RI; CREDENCE Trial Investigators*. Effect of SGLT2 Inhibitors on Stroke and Atrial Fibrillation in Diabetic Kidney Disease: Results From the CREDENCE Trial and Meta-Analysis. Stroke. 2021 May;52(5):1545-1556. doi: 10.1161/STROKEAHA.120.031623. Epub 2021 Apr 20. Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128. Jardine M, Zhou Z, Lambers Heerspink HJ, Hockham C, Li Q, Agarwal R, Bakris GL, Cannon CP, Charytan DM, Greene T, Levin A, Li JW, Neuen BL, Neal B, Oh R, Oshima M, Pollock C, Wheeler DC, de Zeeuw D, Zhang H, Zinman B, Mahaffey KW, Perkovic V. Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria: A CREDENCE Secondary Analysis. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):384-395. doi: 10.2215/CJN.15260920. Epub 2021 Feb 22. Ye N, Jardine MJ, Oshima M, Hockham C, Heerspink HJL, Agarwal R, Bakris G, Schutte AE, Arnott C, Chang TI, Gorriz JL, Cannon CP, Charytan DM, de Zeeuw D, Levin A, Mahaffey KW, Neal B, Pollock C, Wheeler DC, Luca Di Tanna G, Cheng H, Perkovic V, Neuen BL. Blood Pressure Effects of Canagliflozin and Clinical Outcomes in Type 2 Diabetes and Chronic Kidney Disease: Insights From the CREDENCE Trial. Circulation. 2021 May 4;143(18):1735-1749. doi: 10.1161/CIRCULATIONAHA.120.048740. Epub 2021 Feb 8. Sarraju A, Li J, Cannon CP, Chang TI, Agarwal R, Bakris G, Charytan DM, de Zeeuw D, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Perkovic V, Jardine M, Mahaffey KW. Effects of canagliflozin on cardiovascular, renal, and safety outcomes in participants with type 2 diabetes and chronic kidney disease according to history of heart failure: Results from the CREDENCE trial. Am Heart J. 2021 Mar;233:141-148. doi: 10.1016/j.ahj.2020.12.008. Epub 2020 Dec 22. Durkin M, Blais J. Linear Projection of Estimated Glomerular Filtration Rate Decline with Canagliflozin and Implications for Dialysis Utilization and Cost in Diabetic Nephropathy. Diabetes Ther. 2021 Feb;12(2):499-508. doi: 10.1007/s13300-020-00953-4. Epub 2020 Dec 18. Willis M, Nilsson A, Kellerborg K, Ball P, Roe R, Traina S, Beale R, Newell I. Cost-Effectiveness of Canagliflozin Added to Standard of Care for Treating Diabetic Kidney Disease (DKD) in Patients with Type 2 Diabetes Mellitus (T2DM) in England: Estimates Using the CREDEM-DKD Model. Diabetes Ther. 2021 Jan;12(1):313-328. doi: 10.1007/s13300-020-00968-x. Epub 2020 Dec 2. Willis M, Asseburg C, Slee A, Nilsson A, Neslusan C. Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data. Diabetes Ther. 2020 Nov;11(11):2657-2676. doi: 10.1007/s13300-020-00923-w. Epub 2020 Sep 15. Jardine MJ, Zhou Z, Mahaffey KW, Oshima M, Agarwal R, Bakris G, Bajaj HS, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Di Tanna GL, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Qiu R, Sun T, Wheeler DC, Zhang H, Zinman B, Rosenthal N, Perkovic V; CREDENCE Study Investigators. Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial. J Am Soc Nephrol. 2020 May;31(5):1128-1139. doi: 10.1681/ASN.2019111168. Cannon CP, Perkovic V, Agarwal R, Baldassarre J, Bakris G, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Jardine MJ, Levin A, Li JW, Neal B, Pollock C, Wheeler DC, Zhang H, Zinman B, Mahaffey KW. Evaluating the Effects of Canagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease According to Baseline HbA1c, Including Those With HbA1c <7%: Results From the CREDENCE Trial. Circulation. 2020 Feb 4;141(5):407-410. doi: 10.1161/CIRCULATIONAHA.119.044359. Epub 2019 Nov 11. No abstract available. Mahaffey KW, Jardine MJ, Bompoint S, Cannon CP, Neal B, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Capuano G, de Zeeuw D, Greene T, Levin A, Pollock C, Sun T, Wheeler DC, Yavin Y, Zhang H, Zinman B, Rosenthal N, Brenner BM, Perkovic V. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups. Circulation. 2019 Aug 27;140(9):739-750. doi: 10.1161/CIRCULATIONAHA.119.042007. Epub 2019 Jul 11. Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14. Jardine MJ, Mahaffey KW, Neal B, Agarwal R, Bakris GL, Brenner BM, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Levin A, Pollock C, Wheeler DC, Xie J, Zhang H, Zinman B, Desai M, Perkovic V; CREDENCE study investigators. The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics. Am J Nephrol. 2017 Dec 13;46(6):462-472. doi: 10.1159/000484633. Online ahead of print.
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/91/NCT02065791/Prot_000.pdf
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https://cdn.clinicaltrials.gov/large-docs/91/NCT02065791/SAP_001.pdf
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Results are available at
https://clinicaltrials.gov/study/NCT02065791
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