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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03036150
Other study ID # D169AC00001
Secondary ID 2016-003896-24
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2, 2017
Est. completion date June 12, 2020

Study information

Verified date June 2021
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Dapagliflozin
10 mg or 5 mg tablets given once daily, per oral use.
Placebo
Placebo matching dapagliflozin 10 mg or 5 mg

Locations

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
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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
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Mexico Research Site Mazatlán
Mexico Research Site Mexico
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Peru Research Site Arequipa
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Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
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Peru Research Site Piura
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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
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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
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Spain Research Site Burela (Lugo)
Spain Research Site L'Hospitalet de Llobregat
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Spain Research Site Málaga
Spain Research Site Santiago de Compostela
Spain Research Site Sevilla
Spain Research Site Valencia
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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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

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, 

Outcome

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
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