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Clinical Trial Details

Trial ID: L0141
Source ID: NCT03036150
Associated Drug: Dapagliflozin
Title: A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Acronym: Dapa-CKD
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03036150/results
Conditions: Chronic Kidney Disease
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 4304
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2017-02-02
Completion Date: 2020-06-12
Results First Posted: 2021-07-07
Last Update Posted: 2021-07-07
Locations: Research Site, Birmingham, Alabama, 35233, United States|Research Site, Hawaiian Gardens, California, 90716, United States|Research Site, Lomita, California, 90717, United States|Research Site, Los Angeles, California, 90022, United States|Research Site, Palo Alto, California, 94304, United States|Research Site, San Dimas, California, 91773, United States|Research Site, San Ramon, California, 94582, United States|Research Site, Vista, California, 92083, United States|Research Site, Aurora, Colorado, 80045, United States|Research Site, Denver, Colorado, 80246, United States|Research Site, Boynton Beach, Florida, 33435, United States|Research Site, Boynton Beach, Florida, 33472, United States|Research Site, Jacksonville, Florida, 32224, United States|Research Site, Miami Lakes, Florida, 33014, United States|Research Site, Miami, Florida, 33015, United States|Research Site, Miami, Florida, 33144, United States|Research Site, Miami, Florida, 33165, United States|Research Site, Naples, Florida, 34102, United States|Research Site, New Port Richey, Florida, 34652, United States|Research Site, Atlanta, Georgia, 30342-1797, United States|Research Site, Augusta, Georgia, 30904, United States|Research Site, Chicago, Illinois, 60643, United States|Research Site, Iowa City, Iowa, 52242, United States|Research Site, Topeka, Kansas, 66606, United States|Research Site, Wichita, Kansas, 67214, United States|Research Site, Metairie, Louisiana, 70006, United States|Research Site, Boston, Massachusetts, 02111, United States|Research Site, Detroit, Michigan, 48202, United States|Research Site, Flint, Michigan, 48504, United States|Research Site, Duluth, Minnesota, 55805, United States|Research Site, Omaha, Nebraska, 68105, United States|Research Site, Albany, New York, 12208, United States|Research Site, Asheville, North Carolina, 28801, United States|Research Site, Charlotte, North Carolina, 28207, United States|Research Site, Hickory, North Carolina, 28601, United States|Research Site, New Bern, North Carolina, 28562, United States|Research Site, Winston-Salem, North Carolina, 27103, United States|Research Site, Cincinnati, Ohio, 45219, United States|Research Site, Maumee, Ohio, 43537, United States|Research Site, Jersey Shore, Pennsylvania, 17740, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Greer, South Carolina, 29651, United States|Research Site, Kingsport, Tennessee, 37660, United States|Research Site, Nashville, Tennessee, 37232, United States|Research Site, El Paso, Texas, 79935, United States|Research Site, Fort Worth, Texas, 76116, United States|Research Site, Fort Worth, Texas, 76117, United States|Research Site, Fort Worth, Texas, 76164, United States|Research Site, Houston, Texas, 77004, United States|Research Site, Houston, Texas, 77030, United States|Research Site, Odessa, Texas, 79761, United States|Research Site, Burke, Virginia, 22015, United States|Research Site, Manassas, Virginia, 20110, United States|Research Site, Newport News, Virginia, 23606, United States|Research Site, Tacoma, Washington, 98405, United States|Research Site, Buenos Aires, ARG 1425, Argentina|Research Site, Buenos Aires, C1425BGN, Argentina|Research Site, Buenos Aires, C1429BWN, Argentina|Research Site, Caba, C1119ACN, Argentina|Research Site, Caba, C1120AAC, Argentina|Research Site, Ciudad Autonoma Buenos Aires, 1093, Argentina|Research Site, Ciudad Autonoma de Buenos Aire, C1407GTN, Argentina|Research Site, Cordoba, 5000, Argentina|Research Site, Cordoba, X5006CBI, Argentina|Research Site, Corrientes, W3400AMZ, Argentina|Research Site, Córdoba, 5000, Argentina|Research Site, Córdoba, X5016LIG, Argentina|Research Site, Mar del Plata, 7600, Argentina|Research Site, Mar del Plata, B7600FZN, Argentina|Research Site, Nueve de julio, B6500EZL, Argentina|Research Site, Rosario, S2000DEJ, Argentina|Research Site, San Luis, D5700CTA, Argentina|Research Site, San Miguel de Tucuman, 4000, Argentina|Research Site, San Miguel de Tucuman, T4000ICL, Argentina|Research Site, San Nicolás, B2900DMH, Argentina|Research Site, Santa Fe, 3000, Argentina|Research Site, Santa Rosa, 6300, Argentina|Research Site, Botucatu, 18.618-686, Brazil|Research Site, Campinas, 13010-001, Brazil|Research Site, Caxias do Sul, 95070-560, Brazil|Research Site, Curitiba, 80440-020, Brazil|Research Site, Joinville, 89227-680, Brazil|Research Site, Porto Alegre, 90020-090, Brazil|Research Site, Porto Alegre, 90035-903, Brazil|Research Site, Porto Alegre, 90610-000, Brazil|Research Site, Salvador, 40415-065, Brazil|Research Site, Santo Andre, 09090-790, Brazil|Research Site, Sao Paulo, 04039-000, Brazil|Research Site, Sao Paulo, 05403-000, Brazil|Research Site, São José do Rio Preto, 15090-000, Brazil|Research Site, São Paulo, 01228-000, Brazil|Research Site, Edmonton, Alberta, T6H 2L4, Canada|Research Site, Red Deer, Alberta, T4N 6V7, Canada|Research Site, Vancouver, British Columbia, V6Z 1Y6, Canada|Research Site, Halifax, Nova Scotia, B3H 1V7, Canada|Research Site, Brampton, Ontario, L6S 0C6, Canada|Research Site, Concord, Ontario, L4K 4M2, Canada|Research Site, Etobicoke, Ontario, M9R 4E1, Canada|Research Site, Kingston, Ontario, K7L 2V7, Canada|Research Site, London, Ontario, N6A 5A5, Canada|Research Site, Oakville, Ontario, L6K 3V3, Canada|Research Site, Oshawa, Ontario, L1G 2B9, Canada|Research Site, Smiths Falls, Ontario, K7A 4W8, Canada|Research Site, Toronto, Ontario, M4C 5T2, Canada|Research Site, Toronto, Ontario, M5G 2N2, Canada|Research Site, Chicoutimi, Quebec, G7H 7K9, Canada|Research Site, Gatineau, Quebec, J8Y 6S8, Canada|Research Site, Greenfield Park, Quebec, J4V 2H1, Canada|Research Site, Montreal, Quebec, H1T 2M4, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Pointe-Claire, Quebec, H9R 3J1, Canada|Research Site, Sherbrooke, Quebec, J1H 5N4, Canada|Research Site, Baotou, 14010, China|Research Site, Beijing, 100034, China|Research Site, Beijing, 100044, China|Research Site, Beijing, 102206, China|Research Site, Changchun, 130021, China|Research Site, Changchun, 130041, China|Research Site, Changsha, 410008, China|Research Site, Chengdu, 610041, China|Research Site, Chengdu, 610072, China|Research Site, Foshan, 528000, China|Research Site, Fuzhou, 350025, China|Research Site, Guangzhou, 510000, China|Research Site, Guangzhou, 510080, China|Research Site, Guangzhou, 510515, China|Research Site, Guiyang, 550004, China|Research Site, Jilin, 132000, China|Research Site, Lanzhou, 730030, China|Research Site, Nan Jin, 210029, China|Research Site, Nanchang, 330006, China|Research Site, Nanjing, 210009, China|Research Site, Nanning, 530021, China|Research Site, Ningbo, 315010, China|Research Site, Shanghai, 200025, China|Research Site, Shanghai, 200040, China|Research Site, Shanghai, 200090, China|Research Site, Shanghai, 200127, China|Research Site, Shengyang, 110004, China|Research Site, Shenzhen, 518053, China|Research Site, Tianjin, 300052, China|Research Site, Wuhan, 430033, China|Research Site, Yinchuan, 750004, China|Research Site, Yueyang, 414000, China|Research Site, Aarhus, 8200, Denmark|Research Site, Gentofte, 2820, Denmark|Research Site, Herlev, 2730, Denmark|Research Site, Hillerød, 3400, Denmark|Research Site, København Ø, 2100, Denmark|Research Site, Roskilde, 4000, Denmark|Research Site, Aschaffenburg, 63739, Germany|Research Site, Bad Oeynhausen, 32545, Germany|Research Site, Berlin, 10117, Germany|Research Site, Dresden, 01307, Germany|Research Site, Düsseldorf, 40210, Germany|Research Site, Essen, 45136, Germany|Research Site, Frankfurt am Main, 60590, Germany|Research Site, Hannover, 30625, Germany|Research Site, Magdeburg, 39120, Germany|Research Site, München, 81675, Germany|Research Site, Münster, 48145, Germany|Research Site, Schweinfurt, 97421, Germany|Research Site, Tübingen, 72076, Germany|Research Site, Ulm, 89081, Germany|Research Site, Budapest, 1083, Hungary|Research Site, Budapest, 1096, Hungary|Research Site, Budapest, 1106, Hungary|Research Site, Budapest, 1212, Hungary|Research Site, Eger, 3300, Hungary|Research Site, Gyula, 5700, Hungary|Research Site, Kistarcsa, 2143, Hungary|Research Site, Miskolc, 3526, Hungary|Research Site, Nyíregyháza, 4400, Hungary|Research Site, Pécs, 7624, Hungary|Research Site, Szeged, 6720, Hungary|Research Site, Velence, 2481, Hungary|Research Site, Ahmedabad, 380016, India|Research Site, Bangalore, 560002, India|Research Site, Calicut, 673008, India|Research Site, Chennai, 600001, India|Research Site, Ernakulam, 683594, India|Research Site, Hyderabad, 500018, India|Research Site, Kanpur, 208002, India|Research Site, Kolkata, 700020, India|Research Site, Lucknow, 226003, India|Research Site, Lucknow, 226005, India|Research Site, Madurai, 625020, India|Research Site, Maharashtra, 411013, India|Research Site, Mangalore, 575003, India|Research Site, Nagpur, 440003, India|Research Site, Nagpur, 440012, India|Research Site, New Delhi, 110017, India|Research Site, Pune, 411001, India|Research Site, Pune, 411040, India|Research Site, Vijayawada, 522002, India|Research Site, Amagasaki-shi, 660-8550, Japan|Research Site, Asahikawa-shi, 070-8644, Japan|Research Site, Beppu-shi, 874-0011, Japan|Research Site, Bunkyo-ku, 113-8431, Japan|Research Site, Chiba-shi, 260-8712, Japan|Research Site, Chuo-ku, 103-0002, Japan|Research Site, Chuo-ku, 103-0027, Japan|Research Site, Chuo-ku, 104-0031, Japan|Research Site, Daito-shi, 574-0074, Japan|Research Site, Fujisawa-shi, 251-8550, Japan|Research Site, Fukuoka-shi, 810-0065, Japan|Research Site, Higashiibaraki-gun, 311-3193, Japan|Research Site, Iizuka-shi, 820-8505, Japan|Research Site, Itabashi-ku, 173-8610, Japan|Research Site, Kamakura-shi, 247-8533, Japan|Research Site, Kanazawa-shi, 920-8650, Japan|Research Site, Kawachinagano-shi, 586-8521, Japan|Research Site, Kawasaki-shi, 211-8510, Japan|Research Site, Kobe-shi, 654-0155, Japan|Research Site, Koga-shi, 811-3195, Japan|Research Site, Koshigaya-shi, 343-8577, Japan|Research Site, Kumamoto-shi, 860-0008, Japan|Research Site, Kurashiki, 701 0192, Japan|Research Site, Matsumoto-shi, 390-8621, Japan|Research Site, Nagano-shi, 388-8004, Japan|Research Site, Nagoya-shi, 455-8530, Japan|Research Site, Nagoya-shi, 456-0058, Japan|Research Site, Nagoya-shi, 457-8511, Japan|Research Site, Naha-shi, 902-0061, Japan|Research Site, Neyagawa-shi, 572-0015, Japan|Research Site, Niigata-shi, 951-8520, Japan|Research Site, Oita-shi, 870-0039, Japan|Research Site, Okayama-shi, 700-8558, Japan|Research Site, Okayama-shi, 701-1192, Japan|Research Site, Osaka-shi, 530-8480, Japan|Research Site, Osaka-shi, 540-0006, Japan|Research Site, Osaka-shi, 558-8558, Japan|Research Site, Saga-shi, 840-8571, Japan|Research Site, Sapporo-shi, 063-0005, Japan|Research Site, Shizuoka-shi, 420-8630, Japan|Research Site, Takarazuka-shi, 665-0861, Japan|Research Site, Toride-shi, 302-0022, Japan|Research Site, Tsu-shi, 514-1101, Japan|Research Site, Tsu-shi, 514-8507, Japan|Research Site, Tsuchiura-shi, 300-0028, Japan|Research Site, Ueda-shi, 386-8610, Japan|Research Site, Uji-shi, 611-0041, Japan|Research Site, Yaizu-shi, 425-8505, Japan|Research Site, Yokohama-shi, 232-0024, Japan|Research Site, Ansan-si, 15355, Korea, Republic of|Research Site, Deagu, 41944, Korea, Republic of|Research Site, Goyang-si, 10380, Korea, Republic of|Research Site, Goyang-si, 10444, Korea, Republic of|Research Site, Gwangju, 61469, Korea, Republic of|Research Site, Jeonju-si, 54907, Korea, Republic of|Research Site, Seongnam-si, 13620, Korea, Republic of|Research Site, Seoul, 03080, Korea, Republic of|Research Site, Seoul, 03722, Korea, Republic of|Research Site, Seoul, 06273, Korea, Republic of|Research Site, Seoul, 06591, Korea, Republic of|Research Site, Seoul, 07061, Korea, Republic of|Research Site, Seoul, 07804, Korea, Republic of|Research Site, Seoul, 07985, Korea, Republic of|Research Site, Uijeongbu-si, 11765, Korea, Republic of|Research Site, Wonju-si, 26426, Korea, Republic of|Research Site, Aguascalientes, 20230, Mexico|Research Site, Cuernavaca, 62448, Mexico|Research Site, Culiacán, 80230, Mexico|Research Site, D.F, 14000, Mexico|Research Site, Durango, 34000, Mexico|Research Site, Guadalajara, 44600, Mexico|Research Site, Mazatlán, 82000, Mexico|Research Site, Mazatlán, 82110, Mexico|Research Site, Mexico, 06700, Mexico|Research Site, Mexico, 14080, Mexico|Research Site, Minatitlán, 96730, Mexico|Research Site, Monterey, 64060, Mexico|Research Site, Monterrey, 64460, Mexico|Research Site, México, 06726, Mexico|Research Site, Saltillo, 25230, Mexico|Research Site, Arequipa, AREQUIPA01, Peru|Research Site, Callao, CALLAO 2, Peru|Research Site, Chorrillos, Lima 9, Peru|Research Site, Cusco, CUSCO 01, Peru|Research Site, Ica, Peru|Research Site, Lima, 14, Peru|Research Site, Lima, 36, Peru|Research Site, Lima, L27, Peru|Research Site, Lima, LIMA 01, Peru|Research Site, Lima, LIMA 1, Peru|Research Site, Lima, LIMA 27, Peru|Research Site, Lima, LIMA 31, Peru|Research Site, Piura, Peru|Research Site, San Isidro, Lima 27, Peru|Research Site, San Miguel, Lima 32, Peru|Research Site, Bacolod, 6100, Philippines|Research Site, Cebu City, 6000, Philippines|Research Site, Cebu, 6000, Philippines|Research Site, Dasmarinas City, 4114, Philippines|Research Site, Davao City, PH-8000, Philippines|Research Site, Iloilo City, 5000, Philippines|Research Site, Iloilo, 5000, Philippines|Research Site, Makati City, 1218, Philippines|Research Site, Marikina, 1800, Philippines|Research Site, Quezon City, 1101, Philippines|Research Site, Bielsko-Biała, 43-300, Poland|Research Site, Bochnia, 32-700, Poland|Research Site, Chorzów, 41-500, Poland|Research Site, Ciechanów, 06-400, Poland|Research Site, Katowice, 40-081, Poland|Research Site, Katowice, 40-648, Poland|Research Site, Kraków, 31-156, Poland|Research Site, Kraków, 31-530, Poland|Research Site, Legnica, 59-220, Poland|Research Site, Olsztyn, 10-561, Poland|Research Site, Ostrowiec Świętokrzyski, 27-400, Poland|Research Site, Oława, 55-200, Poland|Research Site, Poznań, 60-821, Poland|Research Site, Ruda Śląska, 41-709, Poland|Research Site, Rzeszów, 35-055, Poland|Research Site, Szczecin, 70-111, Poland|Research Site, Tczew, 83-110, Poland|Research Site, Łódź, 92-213, Poland|Research Site, Chelyabinsk, 454091, Russian Federation|Research Site, Ekaterinburg, 620039, Russian Federation|Research Site, Kazan, 420012, Russian Federation|Research Site, Kemerovo, 650002, Russian Federation|Research Site, Kemerovo, 650066, Russian Federation|Research Site, Krasnoyarsk, 660062, Russian Federation|Research Site, Moscow, 123995, Russian Federation|Research Site, Omsk, 644112, Russian Federation|Research Site, Perm, 614000, Russian Federation|Research Site, Perm, 614068, Russian Federation|Research Site, Rostov-on-Don, 344022, Russian Federation|Research Site, Saint Petersburg, 196601, Russian Federation|Research Site, Saint-Petersburg, 199106, Russian Federation|Research Site, Saratov, 410053, Russian Federation|Research Site, St.Petersburg, 194354, Russian Federation|Research Site, Tver, 170036, Russian Federation|Research Site, Ufa, 450071, Russian Federation|Research Site, Vladikavkaz, 362007, Russian Federation|Research Site, Volgograd, 400131, Russian Federation|Research Site, Yaroslavl, 150062, Russian Federation|Research Site, Barcelona, 08003, Spain|Research Site, Barcelona, 08035, Spain|Research Site, Burela (Lugo), 27880, Spain|Research Site, L'Hospitalet de Llobregat, 08907, Spain|Research Site, La Coruña, 15006, Spain|Research Site, Madrid, 28041, Spain|Research Site, Málaga, 29010, Spain|Research Site, Santiago de Compostela, 15706, Spain|Research Site, Sevilla, 41071, Spain|Research Site, Valencia, 46010, Spain|Research Site, Valencia, 46017, Spain|Research Site, Göteborg, 413 45, Sweden|Research Site, Malmö, 205 02, Sweden|Research Site, Stockholm, 141 86, Sweden|Research Site, Stockholm, 182 88, Sweden|Research Site, Uppsala, 751 85, Sweden|Research Site, Cherkasy, 18009, Ukraine|Research Site, Chernivtsі, 58018, Ukraine|Research Site, Dnipro, 49005, Ukraine|Research Site, Dnipro, 49102, Ukraine|Research Site, Ivano-Frankivsk, 76008, Ukraine|Research Site, Ivano-Frankivsk, 76018, Ukraine|Research Site, Kharkiv Region, 61039, Ukraine|Research Site, Kharkiv Region, 61103, Ukraine|Research Site, Kharkiv Region, 61166, Ukraine|Research Site, Kyiv, 02091, Ukraine|Research Site, Kyiv, 02125, Ukraine|Research Site, Kyiv, 04053, Ukraine|Research Site, Kyiv, 4050, Ukraine|Research Site, Lutsk, 43005, Ukraine|Research Site, Odesa, 65025, Ukraine|Research Site, Poltava, 36011, Ukraine|Research Site, Rivne, 33027, Ukraine|Research Site, Ternopil, 46000, Ukraine|Research Site, Vinnytsia, 21001, Ukraine|Research Site, Vinnytsia, 21018, Ukraine|Research Site, Zaporizhzhia, 69600, Ukraine|Research Site, Cardiff, CF14 4XW, United Kingdom|Research Site, Glasgow, G51 4TF, United Kingdom|Research Site, Hull, HU3 2JZ, United Kingdom|Research Site, Kent, BR6 8ND, United Kingdom|Research Site, Leicester, LE5 4PW, United Kingdom|Research Site, London, E1 1BB, United Kingdom|Research Site, London, SE5 9RS, United Kingdom|Research Site, Salford, M6 8HD, United Kingdom|Research Site, Swansea, SA6 6NL, United Kingdom|Research Site, Bien Hoa, 810000, Vietnam|Research Site, Hanoi, 10000, Vietnam|Research Site, Ho Chi Minh city, 700000, Vietnam|Research Site, Ho Chi Minh City, 70000, Vietnam|Research Site, Ho Chi Minh City, 9000, Vietnam|Research Site, Ho Chi Minh, 10000, Vietnam|Research Site, Ho Chi Minh, 7000000, Vietnam|Research Site, Hochiminh, 700000, Vietnam
URL: https://clinicaltrials.gov/show/NCT03036150

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D445 Dapagliflozin small molecule DB06292 Details