RecruitingPhase 2NCT07222917

A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

Sponsor

AstraZeneca

Enrollment

218 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease and Hypertension

Summary

International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two blood-pressure and kidney-protecting medications — dapagliflozin (a diabetes drug also used for kidney disease) and baxdrostat (an aldosterone-lowering drug) — works better than baxdrostat alone in reducing protein in the urine, which is a sign of kidney damage, in people with chronic kidney disease and high blood pressure. **You may be eligible if...** - You are 18 years or older - You have chronic kidney disease with moderately reduced kidney function (eGFR between 30 and 90) - You have a significant amount of protein in your urine (UACR between 200 and 5000) - You have high blood pressure (systolic blood pressure of 130 mmHg or more at screening) - You are already taking a stable dose of an ACE inhibitor or ARB (a standard blood pressure medication for kidney protection) **You may NOT be eligible if...** - You have Type 1 diabetes, or Type 2 diabetes that is very poorly controlled - Your blood pressure is extremely high (systolic above 180 mmHg) - You have dangerously high potassium levels - You have had a stroke, heart attack, or hospitalization for heart failure in the past 3 months - You are currently taking potassium-sparing water pills or aldosterone blockers like spironolactone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBaxdrostat/dapagliflozin

baxdrostat tablet dapagliflozin tablet

DRUGBaxdrostat/Placebo

baxdrostat tablet placebo tablet

Locations(71)

Research Site

Surprise, Arizona, United States

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Hollywood, Florida, United States

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Port Charlotte, Florida, United States

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Port Orange, Florida, United States

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Atlanta, Georgia, United States

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Champaign, Illinois, United States

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Wichita, Kansas, United States

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Eatontown, New Jersey, United States

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Greenville, North Carolina, United States

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Jacksonville, North Carolina, United States

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New Bern, North Carolina, United States

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Columbus, Ohio, United States

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Media, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Arlington, Texas, United States

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Pasadena, Texas, United States

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San Antonio, Texas, United States

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Woodbridge, Virginia, United States

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Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Mar del Plata, Argentina

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Rosario, Argentina

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San Nicolás, Argentina

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Pernik, Bulgaria

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Yambol, Bulgaria

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Courtice, Ontario, Canada

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Etobicoke, Ontario, Canada

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Stouffville, Ontario, Canada

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Waterloo, Ontario, Canada

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Montreal, Quebec, Canada

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Anyang-si, South Korea

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Cheonan-si, South Korea

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Goyang-si, South Korea

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Seoul, South Korea

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Badalona, Spain

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Pamplona, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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New Taipei City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Taipei, Taiwan

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Taipei, Taiwan

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Taoyuan, Taiwan

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Bangkoknoi, Thailand

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Changwat Sara Buri, Thailand

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Hat Yai, Thailand

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Muang, Thailand

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Ratchathewi, Thailand

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Adana, Turkey (Türkiye)

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Adapazarı, Turkey (Türkiye)

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Kahramanmaraş, Turkey (Türkiye)

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Kayseri, Turkey (Türkiye)

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Kocaeli, Turkey (Türkiye)

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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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Kyiv, Ukraine

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Kyiv, Ukraine

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Uzhhorod, Ukraine

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Vinnytsia, Ukraine

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Dundee, United Kingdom

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Liverpool, United Kingdom

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London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07222917

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