A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Launched by ASTRAZENECA · Jan 26, 2017
Trial Information
Current as of April 26, 2025
Completed
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Jacksonville, Florida, United States
Kazan, , Russian Federation
Detroit, Michigan, United States
Nyíregyháza, , Hungary
Pune, , India
Cherkasy, , Ukraine
Aurora, Colorado, United States
Tacoma, Washington, United States
Charlotte, North Carolina, United States
Topeka, Kansas, United States
Cincinnati, Ohio, United States
Omaha, Nebraska, United States
Madrid, , Spain
Miskolc, , Hungary
Barcelona, , Spain
Iowa City, Iowa, United States
Philadelphia, Pennsylvania, United States
London, , United Kingdom
Asheville, North Carolina, United States
Kingston, Ontario, Canada
Berlin, , Germany
Hannover, , Germany
Budapest, , Hungary
Málaga, , Spain
Albany, New York, United States
Szeged, , Hungary
Los Angeles, California, United States
Wichita, Kansas, United States
Duluth, Minnesota, United States
New Bern, North Carolina, United States
Winston Salem, North Carolina, United States
Corrientes, , Argentina
London, Ontario, Canada
Sherbrooke, Quebec, Canada
Herlev, , Denmark
Roskilde, , Denmark
Moscow, , Russian Federation
Uppsala, , Sweden
Vista, California, United States
Aguascalientes, , Mexico
Boston, Massachusetts, United States
Nashville, Tennessee, United States
Magdeburg, , Germany
München, , Germany
Ulm, , Germany
Gyula, , Hungary
New Port Richey, Florida, United States
Greer, South Carolina, United States
Kingsport, Tennessee, United States
Szczecin, , Poland
Atlanta, Georgia, United States
Miami Lakes, Florida, United States
Halifax, Nova Scotia, Canada
Piura, , Peru
Valencia, , Spain
Hickory, North Carolina, United States
El Paso, Texas, United States
Newport News, Virginia, United States
Naples, Florida, United States
Mexico, , Mexico
Olsztyn, , Poland
Poltava, , Ukraine
Zaporizhzhia, , Ukraine
Buenos Aires, , Argentina
Beijing, , China
Shanghai, , China
Cebu City, , Philippines
Quezon City, , Philippines
San Isidro, , Peru
Sevilla, , Spain
Odesa, , Ukraine
Salford, , United Kingdom
Red Deer, Alberta, Canada
Legnica, , Poland
Hull, , United Kingdom
Leicester, , United Kingdom
Swansea, , United Kingdom
Sao Paulo, , Brazil
Vancouver, British Columbia, Canada
Chiba Shi, , Japan
Kanazawa Shi, , Japan
Iloilo City, , Philippines
Durango, , Mexico
Niigata Shi, , Japan
Metairie, Louisiana, United States
Burke, Virginia, United States
Boynton Beach, Florida, United States
San Miguel De Tucuman, , Argentina
Curitiba, , Brazil
Smiths Falls, Ontario, Canada
Guangzhou, , China
Nanning, , China
Yinchuan, , China
Aschaffenburg, , Germany
Bad Oeynhausen, , Germany
Münster, , Germany
Eger, , Hungary
Pécs, , Hungary
Cebu, , Philippines
Kemerovo, , Russian Federation
Saint Petersburg, , Russian Federation
Yaroslavl, , Russian Federation
København ø, , Denmark
Essen, , Germany
Frankfurt Am Main, , Germany
Tübingen, , Germany
Ivano Frankivsk, , Ukraine
Houston, Texas, United States
Oshawa, Ontario, Canada
Pointe Claire, Quebec, Canada
L'hospitalet De Llobregat, , Spain
Lomita, California, United States
Palo Alto, California, United States
Changchun, , China
Chengdu, , China
Chicoutimi, Quebec, Canada
Fuzhou, , China
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Monterrey, , Mexico
Kistarcsa, , Hungary
Manassas, Virginia, United States
San Dimas, California, United States
Flint, Michigan, United States
Gwangju, , Korea, Republic Of
San Ramon, California, United States
Miami, Florida, United States
Odessa, Texas, United States
Mar Del Plata, , Argentina
San Nicolás, , Argentina
Santa Fe, , Argentina
São José Do Rio Preto, , Brazil
São Paulo, , Brazil
Brampton, Ontario, Canada
Concord, Ontario, Canada
Changsha, , China
Nanchang, , China
Tianjin, , China
Ahmedabad, , India
Daito Shi, , Japan
Uji Shi, , Japan
Guadalajara, , Mexico
Monterey, , Mexico
Bacolod, , Philippines
Dasmarinas City, , Philippines
Makati City, , Philippines
Katowice, , Poland
Ruda śląska, , Poland
Chelyabinsk, , Russian Federation
Perm, , Russian Federation
Rostov On Don, , Russian Federation
Saratov, , Russian Federation
Tver, , Russian Federation
Ufa, , Russian Federation
Santiago De Compostela, , Spain
Vinnytsia, , Ukraine
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Caba, , Argentina
Rosario, , Argentina
Gatineau, Quebec, Canada
Greenfield Park, Quebec, Canada
Dresden, , Germany
Beppu Shi, , Japan
Itabashi Ku, , Japan
Sapporo Shi, , Japan
Ekaterinburg, , Russian Federation
Vladikavkaz, , Russian Federation
Göteborg, , Sweden
Malmö, , Sweden
Stockholm, , Sweden
Jersey Shore, Pennsylvania, United States
Düsseldorf, , Germany
Iloilo, , Philippines
Kyiv, , Ukraine
Hillerød, , Denmark
Nanjing, , China
Shenzhen, , China
Maumee, Ohio, United States
Fort Worth, Texas, United States
San Luis, , Argentina
Porto Alegre, , Brazil
New Delhi, , India
Chuo Ku, , Japan
Fujisawa Shi, , Japan
Koga Shi, , Japan
Kumamoto Shi, , Japan
Okayama Shi, , Japan
Yokohama Shi, , Japan
Wonju Si, , Korea, Republic Of
D.F, , Mexico
Callao, , Peru
Lima, , Peru
Davao City, , Philippines
Bochnia, , Poland
Chorzów, , Poland
Poznań, , Poland
Rzeszów, , Poland
Omsk, , Russian Federation
Volgograd, , Russian Federation
Kharkiv Region, , Ukraine
Cusco, , Peru
Gentofte, , Denmark
Glasgow, , United Kingdom
Schweinfurt, , Germany
Cardiff, , United Kingdom
Denver, Colorado, United States
Etobicoke, Ontario, Canada
Jilin, , China
Lanzhou, , China
Yueyang, , China
Osaka Shi, , Japan
Tsuchiura Shi, , Japan
Bunkyo Ku, , Japan
Higashiibaraki Gun, , Japan
Ueda Shi, , Japan
St.Petersburg, , Russian Federation
Hawaiian Gardens, California, United States
Nueve De Julio, , Argentina
Ostrowiec świętokrzyski, , Poland
Santa Rosa, , Argentina
Toronto, Ontario, Canada
Velence, , Hungary
Hyderabad, , India
Lucknow, , India
Maharashtra, , India
Nagpur, , India
Vijayawada, , India
Ansan Si, , Korea, Republic Of
Goyang Si, , Korea, Republic Of
Uijeongbu Si, , Korea, Republic Of
Culiacán, , Mexico
Minatitlán, , Mexico
México, , Mexico
Ica, , Peru
Ciechanów, , Poland
Tczew, , Poland
Krasnoyarsk, , Russian Federation
Dnipro, , Ukraine
Lutsk, , Ukraine
Rivne, , Ukraine
Hochiminh, , Vietnam
łódź, , Poland
Ternopil, , Ukraine
Aarhus, , Denmark
Shengyang, , China
Asahikawa Shi, , Japan
Matsumoto Shi, , Japan
Chicago, Illinois, United States
Bielsko Biała, , Poland
Jeonju Si, , Korea, Republic Of
Iizuka Shi, , Japan
Saga Shi, , Japan
Guiyang, , China
Wuhan, , China
Naha Shi, , Japan
Shizuoka Shi, , Japan
Nagoya Shi, , Japan
Arequipa, , Peru
Ningbo, , China
Neyagawa Shi, , Japan
Oita Shi, , Japan
La Coruña, , Spain
Augusta, Georgia, United States
Toride Shi, , Japan
Montreal, Quebec, Canada
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aire, , Argentina
Cordoba, , Argentina
Córdoba, , Argentina
Campinas, , Brazil
Oakville, Ontario, Canada
Baotou, , China
Bangalore, , India
Ernakulam, , India
Kanpur, , India
Kolkata, , India
Fukuoka Shi, , Japan
Kraków, , Poland
Oława, , Poland
Saint Petersburg, , Russian Federation
Ho Chi Minh, , Vietnam
Botucatu, , Brazil
Caxias Do Sul, , Brazil
Joinville, , Brazil
Salvador, , Brazil
Santo Andre, , Brazil
Edmonton, Alberta, Canada
Foshan, , China
Nan Jin, , China
Calicut, , India
Chennai, , India
Madurai, , India
Mangalore, , India
Amagasaki Shi, , Japan
Kamakura Shi, , Japan
Kawachinagano Shi, , Japan
Kawasaki Shi, , Japan
Kobe Shi, , Japan
Koshigaya Shi, , Japan
Kurashiki, , Japan
Nagano Shi, , Japan
Takarazuka Shi, , Japan
Tsu Shi, , Japan
Yaizu Shi, , Japan
Deagu, , Korea, Republic Of
Cuernavaca, , Mexico
Mazatlán, , Mexico
Saltillo, , Mexico
Chorrillos, , Peru
San Miguel, , Peru
Marikina, , Philippines
Burela (Lugo), , Spain
Chernivtsі, , Ukraine
Kent, , United Kingdom
Bien Hoa, , Vietnam
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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