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ACTIVE NOT RECRUITING
NCT06087835
PHASE3

Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria

Official title: A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria

Key Details

Gender

All

Age Range

18 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

1835

Start Date

2023-11-07

Completion Date

2027-02-18

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Zibotentan/Dapagliflozin

Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to

DRUG

Dapagliflozin

Participants will receive dapagliflozin as per the arms they are randomized to

Locations (296)

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Huntsville, Alabama, United States

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Sun City West, Arizona, United States

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Bakersfield, California, United States

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Huntington Park, California, United States

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Los Alamitos, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Oxnard, California, United States

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San Carlos, California, United States

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San Dimas, California, United States

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Tarzana, California, United States

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Victorville, California, United States

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Arvada, Colorado, United States

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Denver, Colorado, United States

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Boynton Beach, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jensen Beach, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Fayetteville, Georgia, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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Hinsdale, Illinois, United States

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Island Lake, Illinois, United States

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Skokie, Illinois, United States

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Bowling Green, Kentucky, United States

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Shreveport, Louisiana, United States

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Silver Spring, Maryland, United States

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Flint, Michigan, United States

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Flint, Michigan, United States

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Troy, Michigan, United States

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City of Saint Peters, Missouri, United States

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Albany, New York, United States

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Middletown, New York, United States

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Orchard Park, New York, United States

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Greenville, North Carolina, United States

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Jacksonville, North Carolina, United States

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Kinston, North Carolina, United States

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New Bern, North Carolina, United States

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Statesville, North Carolina, United States

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Wilmington, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Maumee, Ohio, United States

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Pottstown, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Pearland, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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South Salt Lake, Utah, United States

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Alexandria, Virginia, United States

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Newport News, Virginia, United States

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Mukilteo, Washington, United States

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Spokane, Washington, United States

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Ciudad de Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Mar del Plata, Argentina

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Mar del Plata, Argentina

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Santa Fe, Argentina

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Gosford, Australia

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Meadowbrook, Australia

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Perth, Australia

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Reservoir, Australia

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Reservoir, Australia

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Southport, Australia

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Feldkirch, Austria

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Vienna, Austria

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Belém, Brazil

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Botucatu, Brazil

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Joinville, 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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Dobrich, Bulgaria

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Pleven, Bulgaria

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Plovdiv, Bulgaria

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Stara Zagora, Bulgaria

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London, Ontario, Canada

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Waterloo, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Baotou, China

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Beijing, China

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Beijing, China

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Changsha, China

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Chengdu, China

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Chengdu, China

And 196 more locations on ClinicalTrials.gov