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. (NCT07222917)
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.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (15 items).
Location: Research Site — Surprise, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Systolic blood pressure \> 180 mmHg, or diastolic blood pressure \> 110 mmHg at screening.
- Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening
- Serum sodium \< 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).
- Diabetes mellitus:
- T1DM at the screening visit
- Uncontrolled T2DM at screening: HbA1C \> 10.5% (\> 91 mmol/mol)
- New York Heart Association functional HF class IV at screening
- Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), aldosterone synthase inhibitors, potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening
- Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening HF within previous 3 months prior to randomisation.
- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
- Documented history of adrenal insufficiency.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (71 Sites)
Showing the first 25 of 71 sites.
- Research Site — Surprise, Arizona
- Research Site — Hollywood, Florida
- Research Site — Port Charlotte, Florida
- Research Site — Port Orange, Florida
- Research Site — Atlanta, Georgia
- Research Site — Champaign, Illinois
- Research Site — Wichita, Kansas
- Research Site — Eatontown, New Jersey
- Research Site — Greenville, North Carolina
- Research Site — Jacksonville, North Carolina
- Research Site — New Bern, North Carolina
- Research Site — Columbus, Ohio
- Research Site — Media, Pennsylvania
- Research Site — East Providence, Rhode Island
- Research Site — Arlington, Texas
- Research Site — Pasadena, Texas
- Research Site — San Antonio, Texas
- Research Site — Woodbridge, Virginia
- Research Site — Buenos Aires,
- Research Site — Ciudad de Buenos Aires,
- Research Site — Mar del Plata,
- Research Site — Rosario,
- Research Site — San Nicolás,
- Research Site — Pernik,
- Research Site — Plovdiv,
📞 Contact the Study Coordinator
Phone: (877) 240-9479
Email: information.center@astrazeneca.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Kidney Disease and Hypertension
- A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure — Fairhope, Alabama
- A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. — Fairhope, Alabama
Explore by condition: All Chronic Kidney Disease and Hypertension clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.