A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease (Dapa-CKD)

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Placebo

Detailed Description

This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given once daily in addition to standard of care, to prevent the progression of chronic kidney disease (CKD) or cardiovascular (CV)/renal death.

• Study Type: Interventional
• Enrollment (Actual): 4304
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1429BWN
    • Research Site
  • Buenos Aires, Argentina, ARG 1425
    • Research Site
  • Buenos Aires, Argentina, C1425BGN
    • Research Site
  • Caba, Argentina, C1119ACN
    • Research Site
  • Caba, Argentina, C1120AAC
    • Research Site
  • Ciudad Autonoma Buenos Aires, Argentina, 1093
    • Research Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1407GTN
    • Research Site
  • Cordoba, Argentina, 5000
    • Research Site
  • Cordoba, Argentina, X5006CBI
    • Research Site
  • Corrientes, Argentina, W3400AMZ
    • Research Site
  • Córdoba, Argentina, 5000
    • Research Site
  • Córdoba, Argentina, X5016LIG
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Research Site
  • Mar del Plata, Argentina, B7600FZN
    • Research Site
  • Nueve de julio, Argentina, B6500EZL
    • Research Site
  • Rosario, Argentina, S2000DEJ
    • Research Site
  • San Luis, Argentina, D5700CTA
    • Research Site
  • San Miguel de Tucuman, Argentina, 4000
    • Research Site
  • San Miguel de Tucuman, Argentina, T4000ICL
    • Research Site
  • San Nicolás, Argentina, B2900DMH
    • Research Site
  • Santa Fe, Argentina, 3000
    • Research Site
  • Santa Rosa, Argentina, 6300
    • Research Site
• Brazil
  • Botucatu, Brazil, 18.618-686
    • Research Site
  • Campinas, Brazil, 13010-001
    • Research Site
  • Caxias do Sul, Brazil, 95070-560
    • Research Site
  • Curitiba, Brazil, 80440-020
    • Research Site
  • Joinville, Brazil, 89227-680
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Porto Alegre, Brazil, 90020-090
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Research Site
  • Salvador, Brazil, 40415-065
    • Research Site
  • Santo Andre, Brazil, 09090-790
    • Research Site
  • Sao Paulo, Brazil, 05403-000
    • Research Site
  • Sao Paulo, Brazil, 04039-000
    • Research Site
  • São José do Rio Preto, Brazil, 15090-000
    • Research Site
  • São Paulo, Brazil, 01228-000
    • Research Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6H 2L4
      • Research Site
    • Red Deer, Alberta, Canada, T4N 6V7
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Research Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Research Site
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Research Site
    • Concord, Ontario, Canada, L4K 4M2
      • Research Site
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Research Site
    • Kingston, Ontario, Canada, K7L 2V7
      • Research Site
    • London, Ontario, Canada, N6A 5A5
      • Research Site
    • Oakville, Ontario, Canada, L6K 3V3
      • Research Site
    • Oshawa, Ontario, Canada, L1G 2B9
      • Research Site
    • Smiths Falls, Ontario, Canada, K7A 4W8
      • Research Site
    • Toronto, Ontario, Canada, M4C 5T2
      • Research Site
    • Toronto, Ontario, Canada, M5G 2N2
      • Research Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Research Site
    • Gatineau, Quebec, Canada, J8Y 6S8
      • Research Site
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Research Site
    • Montreal, Quebec, Canada, H4J 1C5
      • Research Site
    • Montreal, Quebec, Canada, H1T 2M4
      • Research Site
    • Pointe-Claire, Quebec, Canada, H9R 3J1
      • Research Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Research Site
• China
  • Baotou, China, 14010
    • Research Site
  • Beijing, China, 100034
    • Research Site
  • Beijing, China, 100044
    • Research Site
  • Beijing, China, 102206
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changchun, China, 130041
    • Research Site
  • Changsha, China, 410008
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Chengdu, China, 610072
    • Research Site
  • Foshan, China, 528000
    • Research Site
  • Fuzhou, China, 350025
    • Research Site
  • Guangzhou, China, 510000
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Guangzhou, China, 510515
    • Research Site
  • Guiyang, China, 550004
    • Research Site
  • Jilin, China, 132000
    • Research Site
  • Lanzhou, China, 730030
    • Research Site
  • Nan Jin, China, 210029
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210009
    • Research Site
  • Nanning, China, 530021
    • Research Site
  • Ningbo, China, 315010
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 200090
    • Research Site
  • Shanghai, China, 200040
    • Research Site
  • Shanghai, China, 200127
    • Research Site
  • Shengyang, China, 110004
    • Research Site
  • Shenzhen, China, 518053
    • Research Site
  • Tianjin, China, 300052
    • Research Site
  • Wuhan, China, 430033
    • Research Site
  • Yinchuan, China, 750004
    • Research Site
  • Yueyang, China, 414000
    • Research Site
• Denmark
  • Aarhus, Denmark, 8200
    • Research Site
  • Gentofte, Denmark, 2820
    • Research Site
  • Herlev, Denmark, 2730
    • Research Site
  • Hillerød, Denmark, 3400
    • Research Site
  • København Ø, Denmark, 2100
    • Research Site
  • Roskilde, Denmark, 4000
    • Research Site
• Germany
  • Aschaffenburg, Germany, 63739
    • Research Site
  • Bad Oeynhausen, Germany, 32545
    • Research Site
  • Berlin, Germany, 10117
    • Research Site
  • Dresden, Germany, 01307
    • Research Site
  • Düsseldorf, Germany, 40210
    • Research Site
  • Essen, Germany, 45136
    • Research Site
  • Frankfurt am Main, Germany, 60590
    • Research Site
  • Hannover, Germany, 30625
    • Research Site
  • Magdeburg, Germany, 39120
    • Research Site
  • München, Germany, 81675
    • Research Site
  • Münster, Germany, 48145
    • Research Site
  • Schweinfurt, Germany, 97421
    • Research Site
  • Tübingen, Germany, 72076
    • Research Site
  • Ulm, Germany, 89081
    • Research Site
• Hungary
  • Budapest, Hungary, 1083
    • Research Site
  • Budapest, Hungary, 1096
    • Research Site
  • Budapest, Hungary, 1106
    • Research Site
  • Budapest, Hungary, 1212
    • Research Site
  • Eger, Hungary, 3300
    • Research Site
  • Gyula, Hungary, 5700
    • Research Site
  • Kistarcsa, Hungary, 2143
    • Research Site
  • Miskolc, Hungary, 3526
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Pécs, Hungary, 7624
    • Research Site
  • Szeged, Hungary, 6720
    • Research Site
  • Velence, Hungary, 2481
    • Research Site
• India
  • Ahmedabad, India, 380016
    • Research Site
  • Bangalore, India, 560002
    • Research Site
  • Calicut, India, 673008
    • Research Site
  • Chennai, India, 600001
    • Research Site
  • Ernakulam, India, 683594
    • Research Site
  • Hyderabad, India, 500018
    • Research Site
  • Kanpur, India, 208002
    • Research Site
  • Kolkata, India, 700020
    • Research Site
  • Lucknow, India, 226003
    • Research Site
  • Lucknow, India, 226005
    • Research Site
  • Madurai, India, 625020
    • Research Site
  • Maharashtra, India, 411013
    • Research Site
  • Mangalore, India, 575003
    • Research Site
  • Nagpur, India, 440003
    • Research Site
  • Nagpur, India, 440012
    • Research Site
  • New Delhi, India, 110017
    • Research Site
  • Pune, India, 411001
    • Research Site
  • Pune, India, 411040
    • Research Site
  • Vijayawada, India, 522002
    • Research Site
• Japan
  • Amagasaki-shi, Japan, 660-8550
    • Research Site
  • Asahikawa-shi, Japan, 070-8644
    • Research Site
  • Beppu-shi, Japan, 874-0011
    • Research Site
  • Bunkyo-ku, Japan, 113-8431
    • Research Site
  • Chiba-shi, Japan, 260-8712
    • Research Site
  • Chuo-ku, Japan, 104-0031
    • Research Site
  • Chuo-ku, Japan, 103-0027
    • Research Site
  • Chuo-ku, Japan, 103-0002
    • Research Site
  • Daito-shi, Japan, 574-0074
    • Research Site
  • Fujisawa-shi, Japan, 251-8550
    • Research Site
  • Fukuoka-shi, Japan, 810-0065
    • Research Site
  • Higashiibaraki-gun, Japan, 311-3193
    • Research Site
  • Iizuka-shi, Japan, 820-8505
    • Research Site
  • Itabashi-ku, Japan, 173-8610
    • Research Site
  • Kamakura-shi, Japan, 247-8533
    • Research Site
  • Kanazawa-shi, Japan, 920-8650
    • Research Site
  • Kawachinagano-shi, Japan, 586-8521
    • Research Site
  • Kawasaki-shi, Japan, 211-8510
    • Research Site
  • Kobe-shi, Japan, 654-0155
    • Research Site
  • Koga-shi, Japan, 811-3195
    • Research Site
  • Koshigaya-shi, Japan, 343-8577
    • Research Site
  • Kumamoto-shi, Japan, 860-0008
    • Research Site
  • Kurashiki, Japan, 701 0192
    • Research Site
  • Matsumoto-shi, Japan, 390-8621
    • Research Site
  • Nagano-shi, Japan, 388-8004
    • Research Site
  • Nagoya-shi, Japan, 457-8511
    • Research Site
  • Nagoya-shi, Japan, 455-8530
    • Research Site
  • Nagoya-shi, Japan, 456-0058
    • Research Site
  • Naha-shi, Japan, 902-0061
    • Research Site
  • Neyagawa-shi, Japan, 572-0015
    • Research Site
  • Niigata-shi, Japan, 951-8520
    • Research Site
  • Oita-shi, Japan, 870-0039
    • Research Site
  • Okayama-shi, Japan, 700-8558
    • Research Site
  • Okayama-shi, Japan, 701-1192
    • Research Site
  • Osaka-shi, Japan, 558-8558
    • Research Site
  • Osaka-shi, Japan, 530-8480
    • Research Site
  • Osaka-shi, Japan, 540-0006
    • Research Site
  • Saga-shi, Japan, 840-8571
    • Research Site
  • Sapporo-shi, Japan, 063-0005
    • Research Site
  • Shizuoka-shi, Japan, 420-8630
    • Research Site
  • Takarazuka-shi, Japan, 665-0861
    • Research Site
  • Toride-shi, Japan, 302-0022
    • Research Site
  • Tsu-shi, Japan, 514-8507
    • Research Site
  • Tsu-shi, Japan, 514-1101
    • Research Site
  • Tsuchiura-shi, Japan, 300-0028
    • Research Site
  • Ueda-shi, Japan, 386-8610
    • Research Site
  • Uji-shi, Japan, 611-0041
    • Research Site
  • Yaizu-shi, Japan, 425-8505
    • Research Site
  • Yokohama-shi, Japan, 232-0024
    • Research Site
• Korea, Republic of
  • Ansan-si, Korea, Republic of, 15355
    • Research Site
  • Deagu, Korea, Republic of, 41944
    • Research Site
  • Goyang-si, Korea, Republic of, 10380
    • Research Site
  • Goyang-si, Korea, Republic of, 10444
    • Research Site
  • Gwangju, Korea, Republic of, 61469
    • Research Site
  • Jeonju-si, Korea, Republic of, 54907
    • Research Site
  • Seongnam-si, Korea, Republic of, 13620
    • Research Site
  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 03080
    • Research Site
  • Seoul, Korea, Republic of, 06273
    • Research Site
  • Seoul, Korea, Republic of, 06591
    • Research Site
  • Seoul, Korea, Republic of, 07985
    • Research Site
  • Seoul, Korea, Republic of, 07061
    • Research Site
  • Seoul, Korea, Republic of, 07804
    • Research Site
  • Uijeongbu-si, Korea, Republic of, 11765
    • Research Site
  • Wonju-si, Korea, Republic of, 26426
    • Research Site
• Mexico
  • Aguascalientes, Mexico, 20230
    • Research Site
  • Cuernavaca, Mexico, 62448
    • Research Site
  • Culiacán, Mexico, 80230
    • Research Site
  • D.F, Mexico, 14000
    • Research Site
  • Durango, Mexico, 34000
    • Research Site
  • Guadalajara, Mexico, 44600
    • Research Site
  • Mazatlán, Mexico, 82110
    • Research Site
  • Mazatlán, Mexico, 82000
    • Research Site
  • Mexico, Mexico, 06700
    • Research Site
  • Mexico, Mexico, 14080
    • Research Site
  • Minatitlán, Mexico, 96730
    • Research Site
  • Monterey, Mexico, 64060
    • Research Site
  • Monterrey, Mexico, 64460
    • Research Site
  • México, Mexico, 06726
    • Research Site
  • Saltillo, Mexico, 25230
    • Research Site
• Peru
  • Arequipa, Peru, AREQUIPA01
    • Research Site
  • Callao, Peru, CALLAO 2
    • Research Site
  • Chorrillos, Peru, Lima 9
    • Research Site
  • Cusco, Peru, CUSCO 01
    • Research Site
  • Ica, Peru
    • Research Site
  • Lima, Peru, L27
    • Research Site
  • Lima, Peru, LIMA 27
    • Research Site
  • Lima, Peru, 14
    • Research Site
  • Lima, Peru, LIMA 01
    • Research Site
  • Lima, Peru, LIMA 1
    • Research Site
  • Lima, Peru, LIMA 31
    • Research Site
  • Lima, Peru, 36
    • Research Site
  • Piura, Peru
    • Research Site
  • San Isidro, Peru, Lima 27
    • Research Site
  • San Miguel, Peru, Lima 32
    • Research Site
• Philippines
  • Bacolod, Philippines, 6100
    • Research Site
  • Cebu, Philippines, 6000
    • Research Site
  • Cebu City, Philippines, 6000
    • Research Site
  • Dasmarinas City, Philippines, 4114
    • Research Site
  • Davao City, Philippines, PH-8000
    • Research Site
  • Iloilo, Philippines, 5000
    • Research Site
  • Iloilo City, Philippines, 5000
    • Research Site
  • Makati City, Philippines, 1218
    • Research Site
  • Marikina, Philippines, 1800
    • Research Site
  • Quezon City, Philippines, 1101
    • Research Site
• Poland
  • Bielsko-Biała, Poland, 43-300
    • Research Site
  • Bochnia, Poland, 32-700
    • Research Site
  • Chorzów, Poland, 41-500
    • Research Site
  • Ciechanów, Poland, 06-400
    • Research Site
  • Katowice, Poland, 40-648
    • Research Site
  • Katowice, Poland, 40-081
    • Research Site
  • Kraków, Poland, 31-156
    • Research Site
  • Kraków, Poland, 31-530
    • Research Site
  • Legnica, Poland, 59-220
    • Research Site
  • Olsztyn, Poland, 10-561
    • Research Site
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Research Site
  • Oława, Poland, 55-200
    • Research Site
  • Poznań, Poland, 60-821
    • Research Site
  • Ruda Śląska, Poland, 41-709
    • Research Site
  • Rzeszów, Poland, 35-055
    • Research Site
  • Szczecin, Poland, 70-111
    • Research Site
  • Tczew, Poland, 83-110
    • Research Site
  • Łódź, Poland, 92-213
    • Research Site
• Russian Federation
  • Chelyabinsk, Russian Federation, 454091
    • Research Site
  • Ekaterinburg, Russian Federation, 620039
    • Research Site
  • Kazan, Russian Federation, 420012
    • Research Site
  • Kemerovo, Russian Federation, 650066
    • Research Site
  • Kemerovo, Russian Federation, 650002
    • Research Site
  • Krasnoyarsk, Russian Federation, 660062
    • Research Site
  • Moscow, Russian Federation, 123995
    • Research Site
  • Omsk, Russian Federation, 644112
    • Research Site
  • Perm, Russian Federation, 614000
    • Research Site
  • Perm, Russian Federation, 614068
    • Research Site
  • Rostov-on-Don, Russian Federation, 344022
    • Research Site
  • Saint Petersburg, Russian Federation, 196601
    • Research Site
  • Saint-Petersburg, Russian Federation, 199106
    • Research Site
  • Saratov, Russian Federation, 410053
    • Research Site
  • St.Petersburg, Russian Federation, 194354
    • Research Site
  • Tver, Russian Federation, 170036
    • Research Site
  • Ufa, Russian Federation, 450071
    • Research Site
  • Vladikavkaz, Russian Federation, 362007
    • Research Site
  • Volgograd, Russian Federation, 400131
    • Research Site
  • Yaroslavl, Russian Federation, 150062
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Burela (Lugo), Spain, 27880
    • Research Site
  • L'Hospitalet de Llobregat, Spain, 08907
    • Research Site
  • La Coruña, Spain, 15006
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Santiago de Compostela, Spain, 15706
    • Research Site
  • Sevilla, Spain, 41071
    • Research Site
  • Valencia, Spain, 46010
    • Research Site
  • Valencia, Spain, 46017
    • Research Site
• Sweden
  • Göteborg, Sweden, 413 45
    • Research Site
  • Malmö, Sweden, 205 02
    • Research Site
  • Stockholm, Sweden, 141 86
    • Research Site
  • Stockholm, Sweden, 182 88
    • Research Site
  • Uppsala, Sweden, 751 85
    • Research Site
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Research Site
  • Chernivtsі, Ukraine, 58018
    • Research Site
  • Dnipro, Ukraine, 49102
    • Research Site
  • Dnipro, Ukraine, 49005
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76018
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76008
    • Research Site
  • Kharkiv Region, Ukraine, 61039
    • Research Site
  • Kharkiv Region, Ukraine, 61103
    • Research Site
  • Kharkiv Region, Ukraine, 61166
    • Research Site
  • Kyiv, Ukraine, 02125
    • Research Site
  • Kyiv, Ukraine, 02091
    • Research Site
  • Kyiv, Ukraine, 04053
    • Research Site
  • Kyiv, Ukraine, 4050
    • Research Site
  • Lutsk, Ukraine, 43005
    • Research Site
  • Odesa, Ukraine, 65025
    • Research Site
  • Poltava, Ukraine, 36011
    • Research Site
  • Rivne, Ukraine, 33027
    • Research Site
  • Ternopil, Ukraine, 46000
    • Research Site
  • Vinnytsia, Ukraine, 21018
    • Research Site
  • Vinnytsia, Ukraine, 21001
    • Research Site
  • Zaporizhzhia, Ukraine, 69600
    • Research Site
• United Kingdom
  • Cardiff, United Kingdom, CF14 4XW
    • Research Site
  • Glasgow, United Kingdom, G51 4TF
    • Research Site
  • Hull, United Kingdom, HU3 2JZ
    • Research Site
  • Kent, United Kingdom, BR6 8ND
    • Research Site
  • Leicester, United Kingdom, LE5 4PW
    • Research Site
  • London, United Kingdom, SE5 9RS
    • Research Site
  • London, United Kingdom, E1 1BB
    • Research Site
  • Salford, United Kingdom, M6 8HD
    • Research Site
  • Swansea, United Kingdom, SA6 6NL
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Research Site
  • California
    • Hawaiian Gardens, California, United States, 90716
      • Research Site
    • Lomita, California, United States, 90717
      • Research Site
    • Los Angeles, California, United States, 90022
      • Research Site
    • Palo Alto, California, United States, 94304
      • Research Site
    • San Dimas, California, United States, 91773
      • Research Site
    • San Ramon, California, United States, 94582
      • Research Site
    • Vista, California, United States, 92083
      • Research Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site
    • Denver, Colorado, United States, 80246
      • Research Site
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Research Site
    • Boynton Beach, Florida, United States, 33472
      • Research Site
    • Jacksonville, Florida, United States, 32224
      • Research Site
    • Miami, Florida, United States, 33165
      • Research Site
    • Miami, Florida, United States, 33144
      • Research Site
    • Miami, Florida, United States, 33015
      • Research Site
    • Miami Lakes, Florida, United States, 33014
      • Research Site
    • Naples, Florida, United States, 34102
      • Research Site
    • New Port Richey, Florida, United States, 34652
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30342-1797
      • Research Site
    • Augusta, Georgia, United States, 30904
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60643
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Research Site
    • Wichita, Kansas, United States, 67214
      • Research Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Research Site
    • Flint, Michigan, United States, 48504
      • Research Site
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Research Site
  • New York
    • Albany, New York, United States, 12208
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Research Site
    • Charlotte, North Carolina, United States, 28207
      • Research Site
    • Hickory, North Carolina, United States, 28601
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Research Site
    • Maumee, Ohio, United States, 43537
      • Research Site
  • Pennsylvania
    • Jersey Shore, Pennsylvania, United States, 17740
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Research Site
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Research Site
    • Nashville, Tennessee, United States, 37232
      • Research Site
  • Texas
    • El Paso, Texas, United States, 79935
      • Research Site
    • Fort Worth, Texas, United States, 76117
      • Research Site
    • Fort Worth, Texas, United States, 76164
      • Research Site
    • Fort Worth, Texas, United States, 76116
      • Research Site
    • Houston, Texas, United States, 77030
      • Research Site
    • Houston, Texas, United States, 77004
      • Research Site
    • Odessa, Texas, United States, 79761
      • Research Site
  • Virginia
    • Burke, Virginia, United States, 22015
      • Research Site
    • Manassas, Virginia, United States, 20110
      • Research Site
    • Newport News, Virginia, United States, 23606
      • Research Site
  • Washington
    • Tacoma, Washington, United States, 98405
      • Research Site
• Vietnam
  • Bien Hoa, Vietnam, 810000
    • Research Site
  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh, Vietnam, 10000
    • Research Site
  • Ho Chi Minh, Vietnam, 7000000
    • Research Site
  • Ho Chi Minh City, Vietnam, 70000
    • Research Site
  • Ho Chi Minh City, Vietnam, 9000
    • Research Site
  • Ho Chi Minh city, Vietnam, 700000
    • Research Site
  • Hochiminh, Vietnam, 700000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of signed informed consent prior to any study specific procedures
• Female or male aged ≥18 years at the time of consent
• eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
• Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1
• Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

Exclusion Criteria:

• Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
• Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
• History of organ transplantation
• Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
• Type 1 diabetes mellitus
• New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
• MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dapagliflozin; Patients will be randomized 1:1 to either dapagliflozin or placebo.	Drug: Dapagliflozin; 10 mg or 5 mg tablets given once daily, per oral use.; Other Names: Forxiga TM; Farxiga TM
Placebo Comparator: Placebo; Placebo matching dapagliflozin.	Drug: Placebo; Placebo matching dapagliflozin 10 mg or 5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.	End Stage Renal Disease (ESRD) is defined as: Sustained eGFR <15 mL/min/1.73m2 or,; Chronic dialysis treatment or,; Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.	Up to 38.2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.	End Stage Renal Disease (ESRD) is defined as: Sustained eGFR <15 mL/min/1.73m2 or,; Chronic dialysis treatment or,; Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.	Up to 38.2 months
Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.	The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.	Up to 38.2 months
Time to Death From Any Cause.	The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.	Up to 38.2 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Helpful Links

• redacted protocol
• redacted Statistical Analysis Plan

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): June 12, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease (CKD); Cardiovascular Events (CV); Phase III outcome trial
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: D169AC00001; 2016-003896-24 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No