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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. (BaxDuo-Baltic) Phase 2 218 Double-Blind International

Recruiting
Clinical Trial NCT07222917 (BaxDuo-Baltic) is designed to study Treatment for Chronic Kidney Disease and Hypertension. It is a Phase 2 interventional study that is recruiting, having started on 5 December 2025, with plans to enroll 218 participants. Led by AstraZeneca, it is expected to complete by 24 May 2027. The latest data from ClinicalTrials.gov was last updated on 3 April 2026.
Brief 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.
Detailed Description
This is a Phase IIb, randomised, multicentre, double-blind, parallel-group study aiming to determine the effect on albuminuria, as well as safety, of baxdrostat/dapagliflozin compared with baxdrostat/placebo, when given to participants with CKD and high blood pressure.

Study population will include participants ≥ 18 years old with CKD. Participants with or without a diagnosis of T2DM and with or without an SGLT2i tr...

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Official Title

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.

Conditions
Chronic Kidney Disease and Hypertension
Other Study IDs
  • BaxDuo-Baltic
  • D6972C00006
NCT ID Number
Start Date (Actual)
2025-12-05
Last Update Posted
2026-04-03
Completion Date (Estimated)
2027-05-24
Enrollment (Estimated)
218
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Chronic kidney disease
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalBaxdrostat/dapagliflozin
Participants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily.
Baxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
Placebo ComparatorBaxdrostat /placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily
Baxdrostat/Placebo
baxdrostat tablet placebo tablet
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
Up to 12 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.

  2. Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening

  3. Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening

  4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.

  5. Stable and maximum daily tolerated dose of either an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to the screening visit, if not medically contraindicated.

  6. Participants with:

    1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
    2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
  7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.

  1. Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.

  2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening

  3. Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).

  4. Diabetes mellitus:

    1. T1DM at the screening visit
    2. Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
  5. New York Heart Association functional HF class IV at screening

  6. 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

  7. 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.

  8. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.

  9. Documented history of adrenal insufficiency.

  10. Any dialysis (including for acute kidney injury) within 3 months prior to the screening

  11. Any acute kidney injury within 3 months prior to the screening visit.

  12. Prohibited concomitant medications

AstraZeneca logoAstraZeneca
Study Central Contact
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
71 Study Locations in 11 Countries

Arizona

Research Site, Surprise, Arizona, 85374, United States
Recruiting

Florida

Research Site, Hollywood, Florida, 33021, United States
Recruiting
Research Site, Port Charlotte, Florida, 33952, United States
Recruiting
Research Site, Port Orange, Florida, 32127, United States
Recruiting

Georgia

Research Site, Atlanta, Georgia, 30344, United States
Recruiting

Illinois

Research Site, Champaign, Illinois, 61822, United States
Recruiting

Kansas

Research Site, Wichita, Kansas, 67214, United States
Recruiting

New Jersey

Research Site, Eatontown, New Jersey, 07724, United States
Recruiting

North Carolina

Research Site, Greenville, North Carolina, 27834, United States
Recruiting
Research Site, Jacksonville, North Carolina, 28546, United States
Recruiting
Research Site, New Bern, North Carolina, 28562, United States
Recruiting

Ohio

Research Site, Columbus, Ohio, 43215, United States
Recruiting

Pennsylvania

Research Site, Media, Pennsylvania, 19063, United States
Recruiting

Rhode Island

Research Site, East Providence, Rhode Island, 02914, United States
Recruiting

Texas

Research Site, Arlington, Texas, 76015, United States
Recruiting
Research Site, Pasadena, Texas, 77504, United States
Recruiting
Research Site, San Antonio, Texas, 78212, United States
Recruiting

Virginia

Research Site, Woodbridge, Virginia, 22192, United States
Recruiting
Research Site, Buenos Aires, C1060AAB, Argentina
Withdrawn
Research Site, Ciudad de Buenos Aires, C1425AGC, Argentina
Not yet recruiting
Research Site, Mar del Plata, 7600, Argentina
Not yet recruiting
Research Site, Rosario, S2000CVD, Argentina
Not yet recruiting
Research Site, San Nicolás, B2900DMH, Argentina
Not yet recruiting
Research Site, Pernik, 2300, Bulgaria
Withdrawn
Research Site, Plovdiv, 4004, Bulgaria
Withdrawn
Research Site, Sofia, 1431, Bulgaria
Withdrawn
Research Site, Sofia, 1680, Bulgaria
Withdrawn
Research Site, Sofia, 1756, Bulgaria
Withdrawn
Research Site, Sofia, 1756, Bulgaria
Not yet recruiting
Research Site, Yambol, 8600, Bulgaria
Not yet recruiting

Ontario

Research Site, Courtice, Ontario, L1E 2J5, Canada
Recruiting
Research Site, Etobicoke, Ontario, M9W 6V1, Canada
Recruiting
Research Site, Stouffville, Ontario, L4A1H2, Canada
Recruiting
Research Site, Waterloo, Ontario, N2T 0C1, Canada
Recruiting

Quebec

Research Site, Montreal, Quebec, H4J 1C5, Canada
Not yet recruiting
Research Site, Anyang-si, 14068, South Korea
Withdrawn
Research Site, Cheonan-si, 31151, South Korea
Withdrawn
Research Site, Goyang-si, 10380, South Korea
Withdrawn
Research Site, Seoul, 04401, South Korea
Withdrawn
Research Site, Badalona, 08916, Spain
Withdrawn
Research Site, Pamplona, 31008, Spain
Withdrawn
Research Site, Valencia, 46010, Spain
Withdrawn
Research Site, Kaohsiung City, 80756, Taiwan
Recruiting
Research Site, Kaohsiung City, 83301, Taiwan
Recruiting
Research Site, New Taipei City, 235, Taiwan
Recruiting
Research Site, Taichung, 402, Taiwan
Recruiting
Research Site, Taichung, 433004, Taiwan
Recruiting
Research Site, Taipei, 10002, Taiwan
Recruiting
Research Site, Taipei, 110, Taiwan
Recruiting
Research Site, Taoyuan District, 333, Taiwan
Recruiting
Research Site, Bangkoknoi, 10700, Thailand
Recruiting
Research Site, Changwat Sara Buri, 18000, Thailand
Not yet recruiting
Research Site, Hat Yai, 90110, Thailand
Recruiting
Research Site, Muang, 50200, Thailand
Not yet recruiting
Research Site, Ratchathewi, 10400, Thailand
Not yet recruiting
Research Site, Adana, 01060, Turkey (Türkiye)
Not yet recruiting
Research Site, Adapazarı, 54290, Turkey (Türkiye)
Recruiting
Research Site, Kahramanmaraş, 46040, Turkey (Türkiye)
Recruiting
Research Site, Kayseri, 38039, Turkey (Türkiye)
Recruiting
Research Site, Kocaeli, 41380, Turkey (Türkiye)
Recruiting
Research Site, Kyiv, 01601, Ukraine
Recruiting
Research Site, Kyiv, 02002, Ukraine
Recruiting
Research Site, Kyiv, 02091, Ukraine
Recruiting
Research Site, Kyiv, 03037, Ukraine
Recruiting
Research Site, Kyiv, 03049, Ukraine
Recruiting
Research Site, Kyiv, 04210, Ukraine
Recruiting
Research Site, Uzhhorod, 88018, Ukraine
Recruiting
Research Site, Vinnytsia, 21029, Ukraine
Recruiting
Research Site, Dundee, DD1 9SY, United Kingdom
Active, not recruiting
Research Site, Liverpool, L9 7AL, United Kingdom
Recruiting
Research Site, London, E1 1FR, United Kingdom
Recruiting