- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03036150
En undersøgelse til evaluering af virkningen af Dapagliflozin på nyreresultater og kardiovaskulær dødelighed hos patienter med kronisk nyresygdom (Dapa-CKD)
15. juni 2021 opdateret af: AstraZeneca
Formålet med denne undersøgelse er at evaluere effekten af dapagliflozin på nyreudfald og kardiovaskulær dødelighed hos patienter med kronisk nyresygdom.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Dette er et internationalt, multicenter, hændelsesdrevet, randomiseret, dobbeltblindt, parallelgruppe, placebokontrolleret studie, der evaluerer effekten af dapagliflozin versus placebo, givet én gang dagligt ud over standardbehandlingen for at forhindre progression af kronisk nyre. sygdom (CKD) eller kardiovaskulær (CV)/nyredød.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4304
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, C1429BWN
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Buenos Aires, Argentina, ARG 1425
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Buenos Aires, Argentina, C1425BGN
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Caba, Argentina, C1119ACN
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Caba, Argentina, C1120AAC
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Ciudad Autonoma Buenos Aires, Argentina, 1093
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Ciudad Autonoma de Buenos Aire, Argentina, C1407GTN
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Cordoba, Argentina, 5000
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Cordoba, Argentina, X5006CBI
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Corrientes, Argentina, W3400AMZ
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Córdoba, Argentina, 5000
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Córdoba, Argentina, X5016LIG
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Mar del Plata, Argentina, 7600
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Mar del Plata, Argentina, B7600FZN
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Nueve de julio, Argentina, B6500EZL
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Rosario, Argentina, S2000DEJ
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San Luis, Argentina, D5700CTA
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San Miguel de Tucuman, Argentina, 4000
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San Miguel de Tucuman, Argentina, T4000ICL
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San Nicolás, Argentina, B2900DMH
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Santa Fe, Argentina, 3000
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Santa Rosa, Argentina, 6300
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Botucatu, Brasilien, 18.618-686
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Campinas, Brasilien, 13010-001
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Caxias do Sul, Brasilien, 95070-560
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Curitiba, Brasilien, 80440-020
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Joinville, Brasilien, 89227-680
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Porto Alegre, Brasilien, 90610-000
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Porto Alegre, Brasilien, 90020-090
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Porto Alegre, Brasilien, 90035-903
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Salvador, Brasilien, 40415-065
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Santo Andre, Brasilien, 09090-790
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Sao Paulo, Brasilien, 05403-000
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Sao Paulo, Brasilien, 04039-000
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São José do Rio Preto, Brasilien, 15090-000
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São Paulo, Brasilien, 01228-000
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Alberta
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Edmonton, Alberta, Canada, T6H 2L4
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Red Deer, Alberta, Canada, T4N 6V7
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
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Ontario
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Brampton, Ontario, Canada, L6S 0C6
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Concord, Ontario, Canada, L4K 4M2
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Etobicoke, Ontario, Canada, M9R 4E1
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Kingston, Ontario, Canada, K7L 2V7
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London, Ontario, Canada, N6A 5A5
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Oakville, Ontario, Canada, L6K 3V3
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Oshawa, Ontario, Canada, L1G 2B9
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Smiths Falls, Ontario, Canada, K7A 4W8
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Toronto, Ontario, Canada, M4C 5T2
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Toronto, Ontario, Canada, M5G 2N2
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Quebec
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Chicoutimi, Quebec, Canada, G7H 7K9
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Gatineau, Quebec, Canada, J8Y 6S8
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Greenfield Park, Quebec, Canada, J4V 2H1
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Montreal, Quebec, Canada, H4J 1C5
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Montreal, Quebec, Canada, H1T 2M4
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Pointe-Claire, Quebec, Canada, H9R 3J1
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Sherbrooke, Quebec, Canada, J1H 5N4
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Aarhus, Danmark, 8200
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Gentofte, Danmark, 2820
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Herlev, Danmark, 2730
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Hillerød, Danmark, 3400
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København Ø, Danmark, 2100
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Roskilde, Danmark, 4000
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Chelyabinsk, Den Russiske Føderation, 454091
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Ekaterinburg, Den Russiske Føderation, 620039
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Kazan, Den Russiske Føderation, 420012
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Krasnoyarsk, Den Russiske Føderation, 660062
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Moscow, Den Russiske Føderation, 123995
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Omsk, Den Russiske Føderation, 644112
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Perm, Den Russiske Føderation, 614000
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Perm, Den Russiske Føderation, 614068
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Rostov-on-Don, Den Russiske Føderation, 344022
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Saint Petersburg, Den Russiske Føderation, 196601
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Saint-Petersburg, Den Russiske Føderation, 199106
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Saratov, Den Russiske Føderation, 410053
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St.Petersburg, Den Russiske Føderation, 194354
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Tver, Den Russiske Føderation, 170036
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Ufa, Den Russiske Føderation, 450071
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Vladikavkaz, Den Russiske Føderation, 362007
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Volgograd, Den Russiske Føderation, 400131
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Yaroslavl, Den Russiske Føderation, 150062
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Cardiff, Det Forenede Kongerige, CF14 4XW
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Glasgow, Det Forenede Kongerige, G51 4TF
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Hull, Det Forenede Kongerige, HU3 2JZ
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Kent, Det Forenede Kongerige, BR6 8ND
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Leicester, Det Forenede Kongerige, Le5 4PW
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London, Det Forenede Kongerige, SE5 9RS
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London, Det Forenede Kongerige, E1 1BB
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Salford, Det Forenede Kongerige, M6 8HD
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Swansea, Det Forenede Kongerige, SA6 6NL
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Bacolod, Filippinerne, 6100
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Cebu, Filippinerne, 6000
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Dasmarinas City, Filippinerne, 4114
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Davao City, Filippinerne, PH-8000
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Iloilo, Filippinerne, 5000
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Iloilo City, Filippinerne, 5000
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Makati City, Filippinerne, 1218
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Marikina, Filippinerne, 1800
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Quezon City, Filippinerne, 1101
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
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California
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Hawaiian Gardens, California, Forenede Stater, 90716
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Lomita, California, Forenede Stater, 90717
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Los Angeles, California, Forenede Stater, 90022
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Palo Alto, California, Forenede Stater, 94304
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San Dimas, California, Forenede Stater, 91773
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San Ramon, California, Forenede Stater, 94582
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Vista, California, Forenede Stater, 92083
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
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Denver, Colorado, Forenede Stater, 80246
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Florida
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Boynton Beach, Florida, Forenede Stater, 33435
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Boynton Beach, Florida, Forenede Stater, 33472
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Jacksonville, Florida, Forenede Stater, 32224
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Miami, Florida, Forenede Stater, 33165
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Miami, Florida, Forenede Stater, 33144
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Miami, Florida, Forenede Stater, 33015
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Miami Lakes, Florida, Forenede Stater, 33014
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Naples, Florida, Forenede Stater, 34102
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New Port Richey, Florida, Forenede Stater, 34652
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342-1797
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Augusta, Georgia, Forenede Stater, 30904
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Illinois
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Chicago, Illinois, Forenede Stater, 60643
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
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Wichita, Kansas, Forenede Stater, 67214
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70006
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02111
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
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Flint, Michigan, Forenede Stater, 48504
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68105
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New York
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Albany, New York, Forenede Stater, 12208
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28801
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Charlotte, North Carolina, Forenede Stater, 28207
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Hickory, North Carolina, Forenede Stater, 28601
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New Bern, North Carolina, Forenede Stater, 28562
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Winston-Salem, North Carolina, Forenede Stater, 27103
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
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Maumee, Ohio, Forenede Stater, 43537
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Pennsylvania
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Jersey Shore, Pennsylvania, Forenede Stater, 17740
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Philadelphia, Pennsylvania, Forenede Stater, 19104
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South Carolina
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Greer, South Carolina, Forenede Stater, 29651
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Tennessee
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Kingsport, Tennessee, Forenede Stater, 37660
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Nashville, Tennessee, Forenede Stater, 37232
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Texas
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El Paso, Texas, Forenede Stater, 79935
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Fort Worth, Texas, Forenede Stater, 76117
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Fort Worth, Texas, Forenede Stater, 76164
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Fort Worth, Texas, Forenede Stater, 76116
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Houston, Texas, Forenede Stater, 77030
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Houston, Texas, Forenede Stater, 77004
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Odessa, Texas, Forenede Stater, 79761
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Virginia
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Burke, Virginia, Forenede Stater, 22015
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Manassas, Virginia, Forenede Stater, 20110
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Newport News, Virginia, Forenede Stater, 23606
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Washington
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Tacoma, Washington, Forenede Stater, 98405
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Ahmedabad, Indien, 380016
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Bangalore, Indien, 560002
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Calicut, Indien, 673008
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Chennai, Indien, 600001
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Ernakulam, Indien, 683594
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Hyderabad, Indien, 500018
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Kanpur, Indien, 208002
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Kolkata, Indien, 700020
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Lucknow, Indien, 226003
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Lucknow, Indien, 226005
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Madurai, Indien, 625020
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Maharashtra, Indien, 411013
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Mangalore, Indien, 575003
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Nagpur, Indien, 440003
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Nagpur, Indien, 440012
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New Delhi, Indien, 110017
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Pune, Indien, 411001
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Pune, Indien, 411040
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Vijayawada, Indien, 522002
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Amagasaki-shi, Japan, 660-8550
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Asahikawa-shi, Japan, 070-8644
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Beppu-shi, Japan, 874-0011
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Bunkyo-ku, Japan, 113-8431
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Chuo-ku, Japan, 104-0031
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Daito-shi, Japan, 574-0074
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Fukuoka-shi, Japan, 810-0065
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Higashiibaraki-gun, Japan, 311-3193
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Iizuka-shi, Japan, 820-8505
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Itabashi-ku, Japan, 173-8610
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Kamakura-shi, Japan, 247-8533
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Kanazawa-shi, Japan, 920-8650
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Kawachinagano-shi, Japan, 586-8521
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Koshigaya-shi, Japan, 343-8577
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Kumamoto-shi, Japan, 860-0008
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Kurashiki, Japan, 701 0192
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Matsumoto-shi, Japan, 390-8621
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Nagoya-shi, Japan, 457-8511
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Okayama-shi, Japan, 700-8558
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Osaka-shi, Japan, 558-8558
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Osaka-shi, Japan, 530-8480
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Osaka-shi, Japan, 540-0006
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Saga-shi, Japan, 840-8571
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Sapporo-shi, Japan, 063-0005
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Shizuoka-shi, Japan, 420-8630
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Takarazuka-shi, Japan, 665-0861
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Toride-shi, Japan, 302-0022
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Tsu-shi, Japan, 514-8507
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Tsu-shi, Japan, 514-1101
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Tsuchiura-shi, Japan, 300-0028
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Uji-shi, Japan, 611-0041
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Yaizu-shi, Japan, 425-8505
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Yokohama-shi, Japan, 232-0024
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Baotou, Kina, 14010
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Changsha, Kina, 410008
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Foshan, Kina, 528000
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Fuzhou, Kina, 350025
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Guiyang, Kina, 550004
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Jilin, Kina, 132000
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Nanjing, Kina, 210009
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Aguascalientes, Mexico, 20230
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Culiacán, Mexico, 80230
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D.F, Mexico, 14000
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Durango, Mexico, 34000
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Guadalajara, Mexico, 44600
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Mazatlán, Mexico, 82110
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Mazatlán, Mexico, 82000
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Mexico, Mexico, 06700
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Mexico, Mexico, 14080
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Minatitlán, Mexico, 96730
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Monterey, Mexico, 64060
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Monterrey, Mexico, 64460
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México, Mexico, 06726
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Saltillo, Mexico, 25230
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Arequipa, Peru, AREQUIPA01
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Chorrillos, Peru, Lima 9
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Cusco, Peru, CUSCO 01
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Ica, Peru
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Lima, Peru, L27
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Lima, Peru, LIMA 27
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Lima, Peru, 14
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Lima, Peru, LIMA 01
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Lima, Peru, LIMA 1
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Lima, Peru, LIMA 31
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Lima, Peru, 36
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Piura, Peru
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San Isidro, Peru, Lima 27
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San Miguel, Peru, Lima 32
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Ostrowiec Świętokrzyski, Polen, 27-400
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Ruda Śląska, Polen, 41-709
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Rzeszów, Polen, 35-055
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Szczecin, Polen, 70-111
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Tczew, Polen, 83-110
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Łódź, Polen, 92-213
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Barcelona, Spanien, 08035
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Barcelona, Spanien, 08003
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Burela (Lugo), Spanien, 27880
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L'Hospitalet de Llobregat, Spanien, 08907
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La Coruña, Spanien, 15006
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Madrid, Spanien, 28041
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Málaga, Spanien, 29010
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Santiago de Compostela, Spanien, 15706
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Sevilla, Spanien, 41071
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Valencia, Spanien, 46010
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Göteborg, Sverige, 413 45
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Stockholm, Sverige, 182 88
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Aschaffenburg, Tyskland, 63739
- Research Site
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Bad Oeynhausen, Tyskland, 32545
- Research Site
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Berlin, Tyskland, 10117
- Research Site
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Dresden, Tyskland, 01307
- Research Site
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Düsseldorf, Tyskland, 40210
- Research Site
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Essen, Tyskland, 45136
- Research Site
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Frankfurt am Main, Tyskland, 60590
- Research Site
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Hannover, Tyskland, 30625
- Research Site
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Magdeburg, Tyskland, 39120
- Research Site
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München, Tyskland, 81675
- Research Site
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Münster, Tyskland, 48145
- Research Site
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Schweinfurt, Tyskland, 97421
- Research Site
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Tübingen, Tyskland, 72076
- Research Site
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Ulm, Tyskland, 89081
- Research Site
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Cherkasy, Ukraine, 18009
- Research Site
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Chernivtsі, Ukraine, 58018
- Research Site
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Dnipro, Ukraine, 49102
- Research Site
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Dnipro, Ukraine, 49005
- Research Site
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Ivano-Frankivsk, Ukraine, 76018
- Research Site
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Ivano-Frankivsk, Ukraine, 76008
- Research Site
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Kharkiv Region, Ukraine, 61039
- Research Site
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Kharkiv Region, Ukraine, 61103
- Research Site
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Kharkiv Region, Ukraine, 61166
- Research Site
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Kyiv, Ukraine, 02125
- Research Site
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Kyiv, Ukraine, 02091
- Research Site
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Kyiv, Ukraine, 04053
- Research Site
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Kyiv, Ukraine, 4050
- Research Site
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Lutsk, Ukraine, 43005
- Research Site
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Odesa, Ukraine, 65025
- Research Site
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Poltava, Ukraine, 36011
- Research Site
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Rivne, Ukraine, 33027
- Research Site
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Ternopil, Ukraine, 46000
- Research Site
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Vinnytsia, Ukraine, 21018
- Research Site
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Vinnytsia, Ukraine, 21001
- Research Site
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Zaporizhzhia, Ukraine, 69600
- Research Site
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Budapest, Ungarn, 1083
- Research Site
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Budapest, Ungarn, 1096
- Research Site
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Budapest, Ungarn, 1106
- Research Site
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Budapest, Ungarn, 1212
- Research Site
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Eger, Ungarn, 3300
- Research Site
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Gyula, Ungarn, 5700
- Research Site
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Kistarcsa, Ungarn, 2143
- Research Site
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Miskolc, Ungarn, 3526
- Research Site
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Nyíregyháza, Ungarn, 4400
- Research Site
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Pécs, Ungarn, 7624
- Research Site
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Szeged, Ungarn, 6720
- Research Site
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Velence, Ungarn, 2481
- Research Site
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Bien Hoa, Vietnam, 810000
- Research Site
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Hanoi, Vietnam, 10000
- Research Site
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Ho Chi Minh, Vietnam, 10000
- Research Site
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Ho Chi Minh, Vietnam, 7000000
- Research Site
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Ho Chi Minh City, Vietnam, 70000
- Research Site
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Ho Chi Minh City, Vietnam, 9000
- Research Site
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Ho Chi Minh city, Vietnam, 700000
- Research Site
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Hochiminh, Vietnam, 700000
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 130 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Levering af underskrevet informeret samtykke forud for undersøgelsesspecifikke procedurer
- Kvinde eller mand i alderen ≥18 år på tidspunktet for samtykke
- eGFR ≥25 og ≤75 mL/min/1,73m2 (CKD-EPI Formel) ved besøg 1
- Tegn på øget albuminuri 3 måneder eller mere før besøg 1 og UACR ≥200 og ≤5000 mg/g ved besøg 1
- Stabil og for patienten maksimalt tolereret mærket daglig dosis, behandling med ACE-I eller ARB i mindst 4 uger før besøg 1, hvis ikke medicinsk kontraindiceret,
Ekskluderingskriterier:
- Autosomal dominant eller autosomal recessiv polycystisk nyresygdom, lupus nefritis eller ANCA-associeret vaskulitis
- Modtagelse af cytotoksisk behandling, immunsuppressiv behandling eller anden immunterapi mod primær eller sekundær nyresygdom inden for 6 måneder før indskrivning
- Historie om organtransplantation
- Modtagelse af behandling med en SGLT2-hæmmer inden for 8 uger før optagelse eller tidligere intolerance af en SGLT2-hæmmer
- Type 1 diabetes mellitus
- New York Heart Association (NYHA) klasse IV Kongestiv hjertesvigt på tidspunktet for tilmelding
- MI, ustabil angina, slagtilfælde eller forbigående iskæmisk anfald inden for 12 uger før indskrivning
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Dapagliflozin
Patienterne vil blive randomiseret 1:1 til enten dapagliflozin eller placebo.
|
10 mg eller 5 mg tabletter givet én gang dagligt, pr. oral anvendelse.
Andre navne:
|
|
Placebo komparator: Placebo
Placebo-matchende dapagliflozin.
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Placebo-matchende dapagliflozin 10 mg eller 5 mg
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tid til den første forekomst af nogen af komponenterne i det sammensatte: ≥50 % vedvarende fald i eGFR eller nå ESRD eller CV død eller nyredød.
Tidsramme: Op til 38,2 måneder
|
End Stage Renal Disease (ESRD) er defineret som:
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Op til 38,2 måneder
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tid til den første forekomst af en hvilken som helst af komponenterne i det sammensatte: ≥50 % vedvarende fald i eGFR eller opnåelse af ESRD eller nyredød.
Tidsramme: Op til 38,2 måneder
|
End Stage Renal Disease (ESRD) er defineret som:
|
Op til 38,2 måneder
|
|
Tid til den første forekomst af en af komponenterne i det sammensatte: CV-død eller hospitalsindlæggelse for hjertesvigt.
Tidsramme: Op til 38,2 måneder
|
Cox-regressionsmodellen for proportionale farer tager højde for tiden til hændelsen.
Data rapporteres som antallet af forsøgspersoner med hændelsen, og fareforholdet er inkluderet i afsnittet om statistisk analyse, der er knyttet til datatabellen for resultatmål.
|
Op til 38,2 måneder
|
|
Tid til død af enhver årsag.
Tidsramme: Op til 38,2 måneder
|
Cox-regressionsmodellen for proportionale farer tager højde for tiden til hændelsen.
Data rapporteres som antallet af forsøgspersoner med hændelsen, og fareforholdet er inkluderet i afsnittet om statistisk analyse, der er knyttet til datatabellen for resultatmål.
|
Op til 38,2 måneder
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Gonzalez DE, Foresto RD, Ribeiro AB. SGLT-2 inhibitors in diabetes: a focus on renoprotection. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s17-s24. doi: 10.1590/1806-9282.66.S1.17.
- Piperidou A, Loutradis C, Sarafidis P. SGLT-2 inhibitors and nephroprotection: current evidence and future perspectives. J Hum Hypertens. 2021 Jan;35(1):12-25. doi: 10.1038/s41371-020-00393-4. Epub 2020 Aug 10.
- McEwan P, Darlington O, Miller R, McMurray JJV, Wheeler DC, Heerspink HJL, Briggs A, Bergenheim K, Garcia Sanchez JJ. Cost-Effectiveness of Dapagliflozin as a Treatment for Chronic Kidney Disease: A Health-Economic Analysis of DAPA-CKD. Clin J Am Soc Nephrol. 2022 Nov 2;17(12):1730-41. doi: 10.2215/CJN.03790322. Online ahead of print.
- Jongs N, Chertow GM, Greene T, McMurray JJV, Langkilde AM, Correa-Rotter R, Kashihara N, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators; Members of the DAPA-CKD Trial Committees and Investigators. Correlates and Consequences of an Acute Change in eGFR in Response to the SGLT2 Inhibitor Dapagliflozin in Patients with CKD. J Am Soc Nephrol. 2022 Nov;33(11):2094-2107. doi: 10.1681/ASN.2022030306. Epub 2022 Aug 17.
- Vart P, Correa-Rotter R, Hou FF, Jongs N, Chertow GM, Langkilde AM, McMurray JJV, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Douthat W, Escudero E, Isidto R, Khullar D, Bajaj HS, Wheeler DC, Heerspink HJL. Efficacy and Safety of Dapagliflozin in Patients With CKD Across Major Geographic Regions. Kidney Int Rep. 2022 Feb 2;7(4):699-707. doi: 10.1016/j.ekir.2022.01.1060. eCollection 2022 Apr.
- Waijer SW, Vart P, Cherney DZI, Chertow GM, Jongs N, Langkilde AM, Mann JFE, Mosenzon O, McMurray JJV, Rossing P, Correa-Rotter R, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL. Effect of dapagliflozin on kidney and cardiovascular outcomes by baseline KDIGO risk categories: a post hoc analysis of the DAPA-CKD trial. Diabetologia. 2022 Jul;65(7):1085-1097. doi: 10.1007/s00125-022-05694-6. Epub 2022 Apr 21.
- Heerspink HJL, Jongs N, Chertow GM, Langkilde AM, McMurray JJV, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Greene T; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on the rate of decline in kidney function in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):743-754. doi: 10.1016/S2213-8587(21)00242-4. Epub 2021 Oct 4. Erratum In: Lancet Diabetes Endocrinol. 2022 Oct;10(10):e10.
- Jongs N, Greene T, Chertow GM, McMurray JJV, Langkilde AM, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on urinary albumin excretion in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):755-766. doi: 10.1016/S2213-8587(21)00243-6. Epub 2021 Oct 4.
- McMurray JJV, Wheeler DC, Stefansson BV, Jongs N, Postmus D, Correa-Rotter R, Chertow GM, Hou FF, Rossing P, Sjostrom CD, Solomon SD, Toto RD, Langkilde AM, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of Dapagliflozin in Patients With Kidney Disease, With and Without Heart Failure. JACC Heart Fail. 2021 Nov;9(11):807-820. doi: 10.1016/j.jchf.2021.06.017. Epub 2021 Aug 23. Erratum In: JACC Heart Fail. 2022 Jun;10(6):446-447.
- Persson F, Rossing P, Vart P, Chertow GM, Hou FF, Jongs N, McMurray JJV, Correa-Rotter R, Bajaj HS, Stefansson BV, Toto RD, Langkilde AM, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial. Diabetes Care. 2021 Aug;44(8):1894-1897. doi: 10.2337/dc21-0300. Epub 2021 Jun 28.
- Wheeler DC, Stefansson BV, Jongs N, Chertow GM, Greene T, Hou FF, McMurray JJV, Correa-Rotter R, Rossing P, Toto RD, Sjostrom CD, Langkilde AM, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of dapagliflozin on major adverse kidney and cardiovascular events in patients with diabetic and non-diabetic chronic kidney disease: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Jan;9(1):22-31. doi: 10.1016/S2213-8587(20)30369-7.
- McMurray JJV, Wheeler DC, Stefansson BV, Jongs N, Postmus D, Correa-Rotter R, Chertow GM, Greene T, Held C, Hou FF, Mann JFE, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effect of Dapagliflozin on Clinical Outcomes in Patients With Chronic Kidney Disease, With and Without Cardiovascular Disease. Circulation. 2021 Feb 2;143(5):438-448. doi: 10.1161/CIRCULATIONAHA.120.051675. Epub 2020 Nov 13.
- Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.
- Wheeler DC, Stefansson BV, Batiushin M, Bilchenko O, Cherney DZI, Chertow GM, Douthat W, Dwyer JP, Escudero E, Pecoits-Filho R, Furuland H, Gorriz JL, Greene T, Haller H, Hou FF, Kang SW, Isidto R, Khullar D, Mark PB, McMurray JJV, Kashihara N, Nowicki M, Persson F, Correa-Rotter R, Rossing P, Toto RD, Umanath K, Van Bui P, Wittmann I, Lindberg M, Sjostrom CD, Langkilde AM, Heerspink HJL. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics. Nephrol Dial Transplant. 2020 Oct 1;35(10):1700-1711. doi: 10.1093/ndt/gfaa234.
- Sternlicht HK, Bakris GL. Reductions in albuminuria with SGLT2 inhibitors: a marker for improved renal outcomes in patients without diabetes? Lancet Diabetes Endocrinol. 2020 Jul;8(7):553-555. doi: 10.1016/S2213-8587(20)30185-6. No abstract available.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. februar 2017
Primær færdiggørelse (Faktiske)
12. juni 2020
Studieafslutning (Faktiske)
12. juni 2020
Datoer for studieregistrering
Først indsendt
26. januar 2017
Først indsendt, der opfyldte QC-kriterier
26. januar 2017
Først opslået (Skøn)
30. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D169AC00001
- 2016-003896-24 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kronisk nyresygdom
-
Zhen LiTilmelding efter invitationSamtidig pancreas-Kidney-transplantationKina
-
University Hospital, Basel, SwitzerlandIkke rekrutterer endnuKardiovaskulær-Kidney-metabolsk syndrom | Cradiovascular-Kidney-Liver-Metabolic (CKLM) syndromSchweiz
-
Chung Shan Medical UniversityNational Science and Technology Council, TaiwanIkke rekrutterer endnuFedme type 2 diabetes mellitus | Metabolisk dysfunktion-associeret steatotisk leversygdom | Kardiovaskulær-Kidney-metabolsk syndromTaiwan
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CHU de ReimsIkke rekrutterer endnuFluid reaktionsevne i tidlig transplantationsperiode efter KidneyFrankrig
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Camille N. Kotton, MDKamada, Ltd.; University of Texas Southwestern Medical CenterRekrutteringCytomegalovirus | Nyretransplantation; Komplikationer | Organtransplantation | Levertransplantationskomplikationer | Samtidig lever-Kidney-transplantation; KomplikationerForenede Stater
-
Jules Bordet InstituteMacopharma; Belgian Hematological SocietyRekrutteringRefractory Chronic Graft Versus Host Disease (cGVHD)Belgien
-
Changhai HospitalRui Therapeutics Co., LtdRekrutteringRelapseret/Refraktær Immun Nefropati | Relapsed/Refractory Immune-mediated Kidney DiseaseKina
-
Nanjing Medical UniversityIkke rekrutterer endnuKardiovaskulær-Kidney-metabolsk syndrom
-
Bahria UniversityIslamabad Medical and Dental CollegeAktiv, ikke rekrutterendeAlveolær knogletab Associated Chronic PeriodontitisPakistan
-
West China HospitalIkke rekrutterer endnuPTLD'er | CAEBV (Chronic Active Epstein-Barr Virus Infection) SyndromKina
Kliniske forsøg med Dapagliflozin
-
Shenyang Northern HospitalIkke rekrutterer endnuSGLT2-hæmmere | ACS (akut koronarsyndrom)Kina
-
Oman Ministry of HealthRekrutteringSlutstadie kronisk nyresvigtOman
-
The University of Hong KongIkke rekrutterer endnuHjerte-kar-sygdomme | Hjertefejl | Natrium-Glucose coTransporter-2 hæmmere | Fontan | DapagliflozinHong Kong
-
Dasman Diabetes InstituteKuwait Foundation for the Advancement of SciencesTilmelding efter invitationFedmekirurgiskandidat | Type 2 diabetesKuwait
-
Seug yun Yoon, MDBoryung Pharmaceutical Co., LtdIkke rekrutterer endnuAnæmi | Myelodysplastiske syndromer (MDS)
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RekrutteringHjertefejl | Akut nyreskadeForenede Stater
-
Peter RossingLund University; University Medical Center Groningen; Universitätsklinikum... og andre samarbejdspartnereRekrutteringKronisk nyresygdom (CKD)Spanien, Tyskland, Danmark, Sverige
-
AstraZenecaRekrutteringKronisk nyresygdom og hypertensionForenede Stater, Argentina, Taiwan, Thailand, Bulgarien, Det Forenede Kongerige, Spanien, Canada, Ukraine, Tyrkiet (Türkiye), Sydkorea
-
University Medical Centre LjubljanaRekrutteringHjertefejl | Brystkræft | Arteriel stivhed | Antracyklin-induceret hjertetoksicitet | Endotelfunktion (FMD)Slovenien
-
Washington University School of MedicineRekrutteringØjensygdomme | Nethindedegeneration | Nethindesygdomme | Patologiske Tilstande, Anatomiske | Geografisk atrofiForenede Stater