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

NCT ID: NCT03036150

Last Updated: 2021-07-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2020-06-12

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dapagliflozin

Patients will be randomized 1:1 to either dapagliflozin or placebo.

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

10 mg or 5 mg tablets given once daily, per oral use.

Placebo

Placebo matching dapagliflozin.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching dapagliflozin 10 mg or 5 mg

Interventions

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Dapagliflozin

10 mg or 5 mg tablets given once daily, per oral use.

Intervention Type DRUG

Placebo

Placebo matching dapagliflozin 10 mg or 5 mg

Intervention Type DRUG

Other Intervention Names

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Forxiga TM Farxiga TM

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

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Hawaiian Gardens, California, United States

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Lomita, California, United States

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Los Angeles, California, United States

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Palo Alto, California, United States

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San Dimas, California, United States

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San Ramon, California, United States

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Vista, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Boynton Beach, Florida, United States

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Boynton Beach, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Naples, Florida, United States

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New Port Richey, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Metairie, Louisiana, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Flint, Michigan, United States

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Duluth, Minnesota, United States

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Omaha, Nebraska, United States

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Albany, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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New Bern, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Maumee, Ohio, United States

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Jersey Shore, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Kingsport, Tennessee, United States

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Nashville, Tennessee, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Odessa, Texas, United States

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Burke, Virginia, United States

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Manassas, Virginia, United States

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Newport News, Virginia, United States

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Tacoma, Washington, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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CABA, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Ciudad Autonoma de Buenos Aire, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Mar del Plata, , Argentina

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Mar del Plata, , Argentina

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Nueve de Julio, , Argentina

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Rosario, , Argentina

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San Luis, , Argentina

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San Miguel de Tucumán, , Argentina

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San Miguel de Tucumán, , Argentina

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San Nicolás, , Argentina

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Santa Fe, , Argentina

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Santa Rosa, , Argentina

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Botucatu, , Brazil

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Campinas, , Brazil

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Caxias do Sul, , Brazil

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Curitiba, , Brazil

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Joinville, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Salvador, , Brazil

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Santo André, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Edmonton, Alberta, Canada

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Red Deer, Alberta, Canada

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Vancouver, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Concord, Ontario, Canada

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Etobicoke, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Oakville, Ontario, Canada

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Oshawa, Ontario, Canada

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Smiths Falls, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Gatineau, Quebec, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Baotou, , China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Changchun, , China

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Changsha, , China

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Chengdu, , China

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Chengdu, , China

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Foshan, , China

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Fuzhou, , China

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Guangzhou, , China

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Guangzhou, , China

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Guangzhou, , China

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Guiyang, , China

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Jilin, , China

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Lanzhou, , China

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Nanchang, , China

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Nanjin, , China

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Nanjing, , China

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Nanning, , China

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Ningbo, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shengyang, , China

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Shenzhen, , China

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Tianjin, , China

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Wuhan, , China

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Yinchuan, , China

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Yueyang, , China

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Aarhus, , Denmark

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Gentofte Municipality, , Denmark

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Herlev, , Denmark

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Hillerød, , Denmark

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København Ø, , Denmark

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Roskilde, , Denmark

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Aschaffenburg, , Germany

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Bad Oeynhausen, , Germany

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Berlin, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Frankfurt am Main, , Germany

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Hanover, , Germany

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Magdeburg, , Germany

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München, , Germany

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Münster, , Germany

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Schweinfurt, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Eger, , Hungary

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Gyula, , Hungary

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Kistarcsa, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Velence, , Hungary

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Ahmedabad, , India

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Bangalore, , India

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Calicut, , India

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Chennai, , India

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Ernākulam, , India

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Hyderabad, , India

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Kanpur, , India

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Kolkata, , India

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Lucknow, , India

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Lucknow, , India

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Madurai, , India

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Maharashtra, , India

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Mangalore, , India

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Nagpur, , India

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Nagpur, , India

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New Delhi, , India

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Pune, , India

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Pune, , India

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Vijayawada, , India

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Amagasaki-shi, , Japan

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Asahikawa-shi, , Japan

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Beppu-shi, , Japan

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Bunkyō City, , Japan

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Chiba, , Japan

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Chūōku, , Japan

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Chūōku, , Japan

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Chūōku, , Japan

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Daito-shi, , Japan

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Fujisawa-shi, , Japan

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Fukuoka, , Japan

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Higashiibaraki-gun, , Japan

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Iizuka-shi, , Japan

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Itabashi-ku, , Japan

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Kamakura-shi, , Japan

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Kanazawa, , Japan

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Kawachinagano-shi, , Japan

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Kawasaki-shi, , Japan

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Kobe, , Japan

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Koga-shi, , Japan

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Koshigaya-shi, , Japan

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Kumamoto, , Japan

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Kurashiki, , Japan

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Matsumoto-shi, , Japan

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Nagano, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Naha, , Japan

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Neyagawa, , Japan

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Niigata, , Japan

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Okayama, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saga, , Japan

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Sapporo, , Japan

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Shizuoka, , Japan

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Takarazuka-shi, , Japan

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Toride-shi, , Japan

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Tsu, , Japan

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Tsu, , Japan

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Tsuchiura-shi, , Japan

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Ueda-shi, , Japan

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Uji-shi, , Japan

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Yaizu-shi, , Japan

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Yokohama, , Japan

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Aguascalientes, , Mexico

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Cuernavaca, , Mexico

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Culiacán, , Mexico

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D.F, , Mexico

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Durango, , Mexico

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Guadalajara, , Mexico

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Mazatlán, , Mexico

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Mazatlán, , Mexico

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México, , Mexico

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México, , Mexico

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México, , Mexico

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Minatitlán, , Mexico

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Monterrey, , Mexico

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Monterrey, , Mexico

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Saltillo, , Mexico

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Arequipa, , Peru

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Callao, , Peru

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Chorrillos, , Peru

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Cusco, , Peru

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Ica, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Piura, , Peru

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San Isidro, , Peru

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San Miguel, , Peru

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Bacolod, , Philippines

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Cebu, , Philippines

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Cebu City, , Philippines

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Dasmariñas, , Philippines

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Davao City, , Philippines

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Iloilo City, , Philippines

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Makati City, , Philippines

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Marikina City, , Philippines

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Quezon City, , Philippines

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Bielsko-Biala, , Poland

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Bochnia, , Poland

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Chorzów, , Poland

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Ciechanów, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Legnica, , Poland

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Lodz, , Poland

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Olsztyn, , Poland

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Ostrowiec Świętokrzyski, , Poland

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Oława, , Poland

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Poznan, , Poland

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Ruda Śląska, , Poland

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Rzeszów, , Poland

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Szczecin, , Poland

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Tczew, , Poland

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Chelyabinsk, , Russia

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Kazan', , Russia

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Kemerovo, , Russia

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Kemerovo, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Omsk, , Russia

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Perm, , Russia

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Perm, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tver', , Russia

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Ufa, , Russia

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Vladikavkaz, , Russia

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Volgograd, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Ansan-si, , South Korea

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Deagu, , South Korea

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Goyang-si, , South Korea

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Goyang-si, , South Korea

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Gwangju, , South Korea

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Jeonju, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Uijeongbu-si, , South Korea

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Wŏnju, , South Korea

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A Coruña, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Burela (Lugo), , Spain

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Cherkasy, , Ukraine

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Chernivtsі, , Ukraine

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Dnipro, , Ukraine

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv Region, , Ukraine

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Kharkiv Region, , Ukraine

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Kharkiv Region, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lutsk, , Ukraine

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Odesa, , Ukraine

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Poltava, , Ukraine

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Rivne, , Ukraine

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Ternopil, , Ukraine

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Vinnytsia, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhia, , Ukraine

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Cardiff, , United Kingdom

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Glasgow, , United Kingdom

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Hull, , United Kingdom

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Kent, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Salford, , United Kingdom

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Swansea, , United Kingdom

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Biên Hòa, , Vietnam

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Hanoi, , Vietnam

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Ho Chi Minh City, , Vietnam

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Ho Chi Minh City, , Vietnam

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Ho Chi Minh City, , Vietnam

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Ho Chi Minh City, , Vietnam

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Ho Chi Minh City, , Vietnam

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Hochiminh, , Vietnam

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Countries

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United States Argentina Brazil Canada China Denmark Germany Hungary India Japan Mexico Peru Philippines Poland Russia South Korea Spain Sweden Ukraine United Kingdom Vietnam

References

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Heerspink HJL, Chertow GM, Rossing P, Correa-Rotter R, Sjostrom CD, Toto RD, Wheeler DC, Jongs N. Effects of Dapagliflozin on Progression of CKD According to Different Rates of Pretrial eGFR Loss. Clin J Am Soc Nephrol. 2025 Sep 9. doi: 10.2215/CJN.0000000810. Online ahead of print. No abstract available.

Reference Type DERIVED
PMID: 41128261 (View on PubMed)

Bakker WM, Heerspink HJL, Jongs N, Correa-Rotter R, Rossing P, Toto RD, Wheeler DC, McMurray JJV, Langkilde AM, Gansevoort RT, Chertow GM, Vart P. Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD. J Am Soc Nephrol. 2025 Jul 18. doi: 10.1681/ASN.0000000776. Online ahead of print. No abstract available.

Reference Type DERIVED
PMID: 40679863 (View on PubMed)

Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.

Reference Type DERIVED
PMID: 40658498 (View on PubMed)

Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Jun 17. doi: 10.1681/ASN.0000000766. Online ahead of print. No abstract available.

Reference Type DERIVED
PMID: 40526444 (View on PubMed)

van Mil D, Vart P, Chertow GM, Gansevoort RT, Rossing P, Toto RD, Correa-Rotter R, Langkilde AM, Sjostrom CD, Wheeler DC, Heerspink HJL. Baseline, Early Changes, and Residual Albuminuria: Post Hoc Analysis of a Randomized Clinical Trial of Dapagliflozin in Chronic Kidney Disease. Clin J Am Soc Nephrol. 2024 Dec 1;19(12):1574-1584. doi: 10.2215/CJN.0000000000000550.

Reference Type DERIVED
PMID: 39475817 (View on PubMed)

Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Reference Type DERIVED
PMID: 38770818 (View on PubMed)

Zhang Z, Heerspink HJL, Chertow GM, Correa-Rotter R, Gasparrini A, Jongs N, Langkilde AM, McMurray JJV, Mistry MN, Rossing P, Toto RD, Vart P, Nitsch D, Wheeler DC, Caplin B. Ambient heat exposure and kidney function in patients with chronic kidney disease: a post-hoc analysis of the DAPA-CKD trial. Lancet Planet Health. 2024 Apr;8(4):e225-e233. doi: 10.1016/S2542-5196(24)00026-3.

Reference Type DERIVED
PMID: 38580424 (View on PubMed)

Heerspink HJL, Stack AG, Terkeltaub R, Jongs N, Inker LA, Bjursell M, Maklad N, Perl S, Eklund O, Rikte T, Sjostrom CD, Perkovic V; SAPPHIRE Investigators. Combination Treatment with Verinurad and Allopurinol in CKD: A Randomized Placebo and Active Controlled Trial. J Am Soc Nephrol. 2024 May 1;35(5):594-606. doi: 10.1681/ASN.0000000000000326. Epub 2024 Feb 20.

Reference Type DERIVED
PMID: 38564654 (View on PubMed)

Koshino A, Schechter M, Chertow GM, Vart P, Jongs N, Toto RD, Rossing P, Correa-Rotter R, McMurray JJV, Gorriz JL, Isidto R, Kashihara N, Langkilde AM, Wheeler DC, Heerspink HJL. Dapagliflozin and Anemia in Patients with Chronic Kidney Disease. NEJM Evid. 2023 Jun;2(6):EVIDoa2300049. doi: 10.1056/EVIDoa2300049. Epub 2023 May 19.

Reference Type DERIVED
PMID: 38320128 (View on PubMed)

Yu MK, Vart P, Jongs N, Correa-Rotter R, Rossing P, McMurray JJV, Hou FF, Douthat W, Khullar D, Langkilde AM, Wheeler DC, Heerspink HJL, Chertow GM. Effects of Dapagliflozin in Chronic Kidney Disease Across the Spectrum of Age and by Sex. J Gen Intern Med. 2024 May;39(6):921-930. doi: 10.1007/s11606-023-08397-9. Epub 2023 Dec 14.

Reference Type DERIVED
PMID: 38097862 (View on PubMed)

Fletcher RA, Jongs N, Chertow GM, McMurray JJV, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Rockenschaub P, Rossing P, Correa-Rotter R, Toto RD, Vaduganathan M, Wheeler DC, Heerspink HJL, Neuen BL. Effect of SGLT2 Inhibitors on Discontinuation of Renin-angiotensin System Blockade: A Joint Analysis of the CREDENCE and DAPA-CKD Trials. J Am Soc Nephrol. 2023 Dec 1;34(12):1965-1975. doi: 10.1681/ASN.0000000000000248. Epub 2023 Oct 25.

Reference Type DERIVED
PMID: 37876229 (View on PubMed)

Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.

Reference Type DERIVED
PMID: 37872654 (View on PubMed)

Chertow GM, Correa-Rotter R, Vart P, Jongs N, McMurray JJV, Rossing P, Langkilde AM, Sjostrom CD, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of Dapagliflozin in Chronic Kidney Disease, With and Without Other Cardiovascular Medications: DAPA-CKD Trial. J Am Heart Assoc. 2023 May 2;12(9):e028739. doi: 10.1161/JAHA.122.028739. Epub 2023 Apr 29.

Reference Type DERIVED
PMID: 37119064 (View on PubMed)

Vart P, Jongs N, Wheeler DC, Heerspink HJL, Langkilde AM, Chertow GM. Effectiveness and Safety of Dapagliflozin for Black vs White Patients With Chronic Kidney Disease in North and South America: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e2310877. doi: 10.1001/jamanetworkopen.2023.10877.

Reference Type DERIVED
PMID: 37103935 (View on PubMed)

Willigers BJA, Ouwens M, Briggs A, Heerspink HJL, Pollock C, Pecoits-Filho R, Tangri N, Kovesdy CP, Wheeler DC, Garcia Sanchez JJ. The Role of Expert Opinion in Projecting Long-Term Survival Outcomes Beyond the Horizon of a Clinical Trial. Adv Ther. 2023 Jun;40(6):2741-2751. doi: 10.1007/s12325-023-02503-3. Epub 2023 Apr 18.

Reference Type DERIVED
PMID: 37071317 (View on PubMed)

Schechter M, Jongs N, Chertow GM, Mosenzon O, McMurray JJV, Correa-Rotter R, Rossing P, Langkilde AM, Sjostrom CD, Toto RD, Wheeler DC, Heerspink HJL. Effects of Dapagliflozin on Hospitalizations in Patients With Chronic Kidney Disease : A Post Hoc Analysis of DAPA-CKD. Ann Intern Med. 2023 Jan;176(1):59-66. doi: 10.7326/M22-2115. Epub 2022 Dec 6.

Reference Type DERIVED
PMID: 36469914 (View on PubMed)

Vart P, Vaduganathan M, Jongs N, Remuzzi G, Wheeler DC, Hou FF, McCausland F, Chertow GM, Heerspink HJL. Estimated Lifetime Benefit of Combined RAAS and SGLT2 Inhibitor Therapy in Patients with Albuminuric CKD without Diabetes. Clin J Am Soc Nephrol. 2022 Dec;17(12):1754-1762. doi: 10.2215/CJN.08900722. Epub 2022 Nov 22.

Reference Type DERIVED
PMID: 36414316 (View on PubMed)

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 Dec;17(12):1730-1741. doi: 10.2215/CJN.03790322. Epub 2022 Nov 2.

Reference Type DERIVED
PMID: 36323444 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35977807 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35497805 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35445820 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34619108 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34619106 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34446370 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34183431 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33338413 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33186054 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32970396 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32862232 (View on PubMed)

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.

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PMID: 32778748 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32559465 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31939531 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-003896-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D169AC00001

Identifier Type: -

Identifier Source: org_study_id

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