Chronic Kidney Disease Clinical Trial
— Dapa-CKDOfficial title:
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
| Verified date | June 2021 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.
| Status | Completed |
| Enrollment | 4304 |
| Est. completion date | June 12, 2020 |
| Est. primary completion date | June 12, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 130 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Ciudad Autonoma Buenos Aires | |
| Argentina | Research Site | Ciudad Autonoma de Buenos Aire | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Cordoba | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Corrientes | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Mar del Plata | |
| Argentina | Research Site | Nueve de julio | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | San Luis | |
| Argentina | Research Site | San Miguel de Tucuman | |
| Argentina | Research Site | San Miguel de Tucuman | |
| Argentina | Research Site | San Nicolás | |
| Argentina | Research Site | Santa Fe | |
| Argentina | Research Site | Santa Rosa | |
| Brazil | Research Site | Botucatu | |
| Brazil | Research Site | Campinas | |
| Brazil | Research Site | Caxias do Sul | |
| Brazil | Research Site | Curitiba | |
| Brazil | Research Site | Joinville | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Salvador | |
| Brazil | Research Site | Santo Andre | |
| Brazil | Research Site | São José do Rio Preto | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | São Paulo | |
| Canada | Research Site | Brampton | Ontario |
| Canada | Research Site | Chicoutimi | Quebec |
| Canada | Research Site | Concord | Ontario |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | Etobicoke | Ontario |
| Canada | Research Site | Gatineau | Quebec |
| Canada | Research Site | Greenfield Park | Quebec |
| Canada | Research Site | Halifax | Nova Scotia |
| Canada | Research Site | Kingston | Ontario |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Oakville | Ontario |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Pointe-Claire | Quebec |
| Canada | Research Site | Red Deer | Alberta |
| Canada | Research Site | Sherbrooke | Quebec |
| Canada | Research Site | Smiths Falls | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| China | Research Site | Baotou | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Changchun | |
| China | Research Site | Changchun | |
| China | Research Site | Changsha | |
| China | Research Site | Chengdu | |
| China | Research Site | Chengdu | |
| China | Research Site | Foshan | |
| China | Research Site | Fuzhou | |
| China | Research Site | Guangzhou | |
| China | Research Site | Guangzhou | |
| China | Research Site | Guangzhou | |
| China | Research Site | Guiyang | |
| China | Research Site | Jilin | |
| China | Research Site | Lanzhou | |
| China | Research Site | Nan Jin | |
| China | Research Site | Nanchang | |
| China | Research Site | Nanjing | |
| China | Research Site | Nanning | |
| China | Research Site | Ningbo | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shanghai | |
| China | Research Site | Shengyang | |
| China | Research Site | Shenzhen | |
| China | Research Site | Tianjin | |
| China | Research Site | Wuhan | |
| China | Research Site | Yinchuan | |
| China | Research Site | Yueyang | |
| Denmark | Research Site | Aarhus | |
| Denmark | Research Site | Gentofte | |
| Denmark | Research Site | Herlev | |
| Denmark | Research Site | Hillerød | |
| Denmark | Research Site | København Ø | |
| Denmark | Research Site | Roskilde | |
| Germany | Research Site | Aschaffenburg | |
| Germany | Research Site | Bad Oeynhausen | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Düsseldorf | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Frankfurt am Main | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | München | |
| Germany | Research Site | Münster | |
| Germany | Research Site | Schweinfurt | |
| Germany | Research Site | Tübingen | |
| Germany | Research Site | Ulm | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Budapest | |
| Hungary | Research Site | Eger | |
| Hungary | Research Site | Gyula | |
| Hungary | Research Site | Kistarcsa | |
| Hungary | Research Site | Miskolc | |
| Hungary | Research Site | Nyíregyháza | |
| Hungary | Research Site | Pécs | |
| Hungary | Research Site | Szeged | |
| Hungary | Research Site | Velence | |
| India | Research Site | Ahmedabad | |
| India | Research Site | Bangalore | |
| India | Research Site | Calicut | |
| India | Research Site | Chennai | |
| India | Research Site | Ernakulam | |
| India | Research Site | Hyderabad | |
| India | Research Site | Kanpur | |
| India | Research Site | Kolkata | |
| India | Research Site | Lucknow | |
| India | Research Site | Lucknow | |
| India | Research Site | Madurai | |
| India | Research Site | Maharashtra | |
| India | Research Site | Mangalore | |
| India | Research Site | Nagpur | |
| India | Research Site | Nagpur | |
| India | Research Site | New Delhi | |
| India | Research Site | Pune | |
| India | Research Site | Pune | |
| India | Research Site | Vijayawada | |
| Japan | Research Site | Amagasaki-shi | |
| Japan | Research Site | Asahikawa-shi | |
| Japan | Research Site | Beppu-shi | |
| Japan | Research Site | Bunkyo-ku | |
| Japan | Research Site | Chiba-shi | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Chuo-ku | |
| Japan | Research Site | Daito-shi | |
| Japan | Research Site | Fujisawa-shi | |
| Japan | Research Site | Fukuoka-shi | |
| Japan | Research Site | Higashiibaraki-gun | |
| Japan | Research Site | Iizuka-shi | |
| Japan | Research Site | Itabashi-ku | |
| Japan | Research Site | Kamakura-shi | |
| Japan | Research Site | Kanazawa-shi | |
| Japan | Research Site | Kawachinagano-shi | |
| Japan | Research Site | Kawasaki-shi | |
| Japan | Research Site | Kobe-shi | |
| Japan | Research Site | Koga-shi | |
| Japan | Research Site | Koshigaya-shi | |
| Japan | Research Site | Kumamoto-shi | |
| Japan | Research Site | Kurashiki | |
| Japan | Research Site | Matsumoto-shi | |
| Japan | Research Site | Nagano-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Naha-shi | |
| Japan | Research Site | Neyagawa-shi | |
| Japan | Research Site | Niigata-shi | |
| Japan | Research Site | Oita-shi | |
| Japan | Research Site | Okayama-shi | |
| Japan | Research Site | Okayama-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Osaka-shi | |
| Japan | Research Site | Saga-shi | |
| Japan | Research Site | Sapporo-shi | |
| Japan | Research Site | Shizuoka-shi | |
| Japan | Research Site | Takarazuka-shi | |
| Japan | Research Site | Toride-shi | |
| Japan | Research Site | Tsu-shi | |
| Japan | Research Site | Tsu-shi | |
| Japan | Research Site | Tsuchiura-shi | |
| Japan | Research Site | Ueda-shi | |
| Japan | Research Site | Uji-shi | |
| Japan | Research Site | Yaizu-shi | |
| Japan | Research Site | Yokohama-shi | |
| Korea, Republic of | Research Site | Ansan-si | |
| Korea, Republic of | Research Site | Deagu | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Goyang-si | |
| Korea, Republic of | Research Site | Gwangju | |
| Korea, Republic of | Research Site | Jeonju-si | |
| Korea, Republic of | Research Site | Seongnam-si | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Uijeongbu-si | |
| Korea, Republic of | Research Site | Wonju-si | |
| Mexico | Research Site | Aguascalientes | |
| Mexico | Research Site | Cuernavaca | |
| Mexico | Research Site | Culiacán | |
| Mexico | Research Site | D.F | |
| Mexico | Research Site | Durango | |
| Mexico | Research Site | Guadalajara | |
| Mexico | Research Site | Mazatlán | |
| Mexico | Research Site | Mazatlán | |
| Mexico | Research Site | Mexico | |
| Mexico | Research Site | Mexico | |
| Mexico | Research Site | México | |
| Mexico | Research Site | Minatitlán | |
| Mexico | Research Site | Monterey | |
| Mexico | Research Site | Monterrey | |
| Mexico | Research Site | Saltillo | |
| Peru | Research Site | Arequipa | |
| Peru | Research Site | Callao | |
| Peru | Research Site | Chorrillos | |
| Peru | Research Site | Cusco | |
| Peru | Research Site | Ica | |
| Peru | Research Site | Lima | |
| Peru | Research Site | Lima | |
| Peru | Research Site | Lima | |
| Peru | Research Site | Lima | |
| Peru | Research Site | Lima | |
| Peru | Research Site | Lima | |
| Peru | Research Site | Lima | |
| Peru | Research Site | Piura | |
| Peru | Research Site | San Isidro | |
| Peru | Research Site | San Miguel | |
| Philippines | Research Site | Bacolod | |
| Philippines | Research Site | Cebu | |
| Philippines | Research Site | Cebu City | |
| Philippines | Research Site | Dasmarinas City | |
| Philippines | Research Site | Davao City | |
| Philippines | Research Site | Iloilo | |
| Philippines | Research Site | Iloilo City | |
| Philippines | Research Site | Makati City | |
| Philippines | Research Site | Marikina | |
| Philippines | Research Site | Quezon City | |
| Poland | Research Site | Bielsko-Biala | |
| Poland | Research Site | Bochnia | |
| Poland | Research Site | Chorzów | |
| Poland | Research Site | Ciechanów | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Legnica | |
| Poland | Research Site | Lódz | |
| Poland | Research Site | Olawa | |
| Poland | Research Site | Olsztyn | |
| Poland | Research Site | Ostrowiec Swietokrzyski | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Ruda Slaska | |
| Poland | Research Site | Rzeszów | |
| Poland | Research Site | Szczecin | |
| Poland | Research Site | Tczew | |
| Russian Federation | Research Site | Chelyabinsk | |
| Russian Federation | Research Site | Ekaterinburg | |
| Russian Federation | Research Site | Kazan | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Krasnoyarsk | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | Omsk | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | Perm | |
| Russian Federation | Research Site | Rostov-on-Don | |
| Russian Federation | Research Site | Saint Petersburg | |
| Russian Federation | Research Site | Saint-Petersburg | |
| Russian Federation | Research Site | Saratov | |
| Russian Federation | Research Site | St.Petersburg | |
| Russian Federation | Research Site | Tver | |
| Russian Federation | Research Site | Ufa | |
| Russian Federation | Research Site | Vladikavkaz | |
| Russian Federation | Research Site | Volgograd | |
| Russian Federation | Research Site | Yaroslavl | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Barcelona | |
| Spain | Research Site | Burela (Lugo) | |
| Spain | Research Site | L'Hospitalet de Llobregat | |
| Spain | Research Site | La Coruña | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Málaga | |
| Spain | Research Site | Santiago de Compostela | |
| Spain | Research Site | Sevilla | |
| Spain | Research Site | Valencia | |
| Spain | Research Site | Valencia | |
| Sweden | Research Site | Göteborg | |
| Sweden | Research Site | Malmö | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Stockholm | |
| Sweden | Research Site | Uppsala | |
| Ukraine | Research Site | Cherkasy | |
| Ukraine | Research Site | Chernivts? | |
| Ukraine | Research Site | Dnipro | |
| Ukraine | Research Site | Dnipro | |
| Ukraine | Research Site | Ivano-Frankivsk | |
| Ukraine | Research Site | Ivano-Frankivsk | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kharkiv Region | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Kyiv | |
| Ukraine | Research Site | Lutsk | |
| Ukraine | Research Site | Odesa | |
| Ukraine | Research Site | Poltava | |
| Ukraine | Research Site | Rivne | |
| Ukraine | Research Site | Ternopil | |
| Ukraine | Research Site | Vinnytsia | |
| Ukraine | Research Site | Vinnytsia | |
| Ukraine | Research Site | Zaporizhzhia | |
| United Kingdom | Research Site | Cardiff | |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Hull | |
| United Kingdom | Research Site | Kent | |
| United Kingdom | Research Site | Leicester | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Salford | |
| United Kingdom | Research Site | Swansea | |
| United States | Research Site | Albany | New York |
| United States | Research Site | Asheville | North Carolina |
| United States | Research Site | Atlanta | Georgia |
| United States | Research Site | Augusta | Georgia |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Birmingham | Alabama |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Burke | Virginia |
| United States | Research Site | Charlotte | North Carolina |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Duluth | Minnesota |
| United States | Research Site | El Paso | Texas |
| United States | Research Site | Flint | Michigan |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Fort Worth | Texas |
| United States | Research Site | Greer | South Carolina |
| United States | Research Site | Hawaiian Gardens | California |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Houston | Texas |
| United States | Research Site | Iowa City | Iowa |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jersey Shore | Pennsylvania |
| United States | Research Site | Kingsport | Tennessee |
| United States | Research Site | Lomita | California |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Manassas | Virginia |
| United States | Research Site | Maumee | Ohio |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Miami Lakes | Florida |
| United States | Research Site | Naples | Florida |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | New Bern | North Carolina |
| United States | Research Site | New Port Richey | Florida |
| United States | Research Site | Newport News | Virginia |
| United States | Research Site | Odessa | Texas |
| United States | Research Site | Omaha | Nebraska |
| United States | Research Site | Palo Alto | California |
| United States | Research Site | Philadelphia | Pennsylvania |
| United States | Research Site | San Dimas | California |
| United States | Research Site | San Ramon | California |
| United States | Research Site | Tacoma | Washington |
| United States | Research Site | Topeka | Kansas |
| United States | Research Site | Vista | California |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Winston-Salem | North Carolina |
| Vietnam | Research Site | Bien Hoa | |
| Vietnam | Research Site | Hanoi | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh | |
| Vietnam | Research Site | Ho Chi Minh city | |
| Vietnam | Research Site | Ho Chi Minh City | |
| Vietnam | Research Site | Ho Chi Minh City | |
| Vietnam | Research Site | Hochiminh |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Vietnam, Argentina, Brazil, Canada, China, Denmark, Germany, Hungary, India, Japan, Korea, Republic of, Mexico, Peru, Philippines, Poland, Russian Federation, Spain, Sweden, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
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