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.

Last updated: May 15, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Circulation Disorders

Stress

Williams Syndrome

Treatment

Baxdrostat/dapagliflozin

Baxdrostat/Placebo

Clinical Study ID

NCT07222917
D6972C00006
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Participants of any sex and gender must be ≥ 18 years of age at the time of signingthe 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) atscreening

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

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

  6. Participants with:

  7. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.

  8. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.

  9. Contraceptive use should be consistent with local regulations regarding the methodsof contraception for those participating in clinical studies. Applicable to femaleparticipants.

Exclusion

Exclusion Criteria:

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

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

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

  4. Diabetes mellitus:

  5. T1DM at the screening visit

  6. Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)

  7. New York Heart Association functional HF class IV at screening

  8. Any use of mineralocorticoid receptor antagonists (such as spironolactone,eplerenone, or finerenone), aldosterone synthase inhibitors, potassium-sparingdiuretics (such as triamterene or amiloride), or potassium binders (such as sodiumzirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeksprior to screening

  9. Stroke, transient ischaemic cerebral attack, valve implantation or valvereplacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, orhospitalisation for worsening HF within previous 3 months prior to randomisation.

  10. Known severe hepatic impairment, defined as Child-Pugh Class C, based on recordsthat confirm documented medical history.

  11. Documented history of adrenal insufficiency.

  12. Any dialysis (including for acute kidney injury) within 3 months prior to thescreening

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

  14. Prohibited concomitant medications

Study Design

Total Participants: 218
Treatment Group(s): 2
Primary Treatment: Baxdrostat/dapagliflozin
Phase: 2
Study Start date:
December 05, 2025
Estimated Completion Date:
May 24, 2027

Study 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 treatment at screening are eligible for the study.

The study will include an optional pre-screening period, where participants will be assessed for at least one of the following parameters: eGFR, UACR, potassium, sodium, and BP. Participants who are being treated with SGLT2i at the time of the screening visit will complete a washout period After screening and initial confirmation of eligibility, participants will be randomised to receive either baxdrostat/dapagliflozin or baxdrostat/placebo. For randomisation there will be stratification and capping linked to T2DM status.

The primary objective is to assess the effect of baxdrostat/dapagliflozin compared with baxdrostat/matching placebo on albuminuria, which will be evaluated by change from baseline in UACR.

The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally, whichever occurs last.

A participant is considered to have completed the study if they have completed all periods of the study including the last scheduled procedure shown in the SoA.

Connect with a study center

  • Research Site

    Buenos Aires, C1060AAB
    Argentina

    Site Not Available

  • Research Site

    Buenos Aires 3435910, C1425AGC
    Argentina

    Site Not Available

  • Research Site

    Ciudad de Buenos Aires, C1425AGC
    Argentina

    Active - Recruiting

  • Research Site

    Mar del Plata, 7600
    Argentina

    Active - Recruiting

  • Research Site

    Mar del Plata 3430863, 7600
    Argentina

    Site Not Available

  • Research Site

    Rosario, S2000CVD
    Argentina

    Active - Recruiting

  • Research Site

    San Nicolás, B2900DMH
    Argentina

    Active - Recruiting

  • Research Site

    San Nicolás 3832624, B2900DMH
    Argentina

    Site Not Available

  • Research Site

    Pernik, 2300
    Bulgaria

    Site Not Available

  • Research Site

    Pernik 728330, 2300
    Bulgaria

    Site Not Available

  • Research Site

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Research Site

    Plovdiv 728193, 4004
    Bulgaria

    Site Not Available

  • Research Site

    Sofia, 1756
    Bulgaria

    Active - Recruiting

  • Research Site

    Sofia 727011, 1680
    Bulgaria

    Site Not Available

  • Research Site

    Yambol, 8600
    Bulgaria

    Active - Recruiting

  • Research Site

    Yambol 725578, 8600
    Bulgaria

    Site Not Available

  • Research Site

    Courtice, Ontario L1E 2J5
    Canada

    Active - Recruiting

  • Research Site

    Etobicoke, Ontario M9W 6V1
    Canada

    Active - Recruiting

  • Research Site

    Stouffville, Ontario L4A1H2
    Canada

    Active - Recruiting

  • Research Site

    Waterloo, Ontario N2T 0C1
    Canada

    Active - Recruiting

  • Research Site

    Courtice 5930897, Ontario 6093943 L1E 2J5
    Canada

    Site Not Available

  • Research Site

    Etobicoke 5950268, Ontario 6093943 M9W 6V1
    Canada

    Site Not Available

  • Research Site

    Stouffville 6157718, Ontario 6093943 L4A1H2
    Canada

    Site Not Available

  • Research Site

    Waterloo 6176823, Ontario 6093943 N2T 0C1
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H4J 1C5
    Canada

    Active - Recruiting

  • Research Site

    Montreal 6077243, Quebec 6115047 H4J 1C5
    Canada

    Site Not Available

  • Research Site

    Anyang-si, 14068
    South Korea

    Site Not Available

  • Research Site

    Anyang-si 1846898, 14068
    South Korea

    Site Not Available

  • Research Site

    Cheonan-si, 31151
    South Korea

    Site Not Available

  • Research Site

    Goyang-si, 10380
    South Korea

    Site Not Available

  • Research Site

    Goyang-si 1842485, 10380
    South Korea

    Site Not Available

  • Research Site

    Seoul, 04401
    South Korea

    Site Not Available

  • Research Site

    Seoul 1835848, 04401
    South Korea

    Site Not Available

  • Research Site

    Badalona, 08916
    Spain

    Site Not Available

  • Research Site

    Badalona 3129028, 08916
    Spain

    Site Not Available

  • Research Site

    Pamplona, 31008
    Spain

    Site Not Available

  • Research Site

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Research Site

    Valencia, 46010
    Spain

    Site Not Available

  • Research Site

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Research Site

    Kaohsiung City, 83301
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City 1673820, 80756
    Taiwan

    Site Not Available

  • Research Site

    New Taipei City, 235
    Taiwan

    Active - Recruiting

  • Research Site

    New Taipei City 12908892, 235
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 433004
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung 1668399, 402
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 110
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei 1668341, 110
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan District, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Bangkoknoi, 10700
    Thailand

    Active - Recruiting

  • Research Site

    Changwat Sara Buri, 18000
    Thailand

    Active - Recruiting

  • Research Site

    Changwat Sara Buri 1606418, 18000
    Thailand

    Site Not Available

  • Research Site

    Hat Yai, 90110
    Thailand

    Active - Recruiting

  • Research Site

    Hat Yai 1610780, 90110
    Thailand

    Site Not Available

  • Research Site

    Muang, 50200
    Thailand

    Active - Recruiting

  • Research Site

    Ratchathewi, 10400
    Thailand

    Active - Recruiting

  • Research Site

    Ratchathewi 7026885, 10400
    Thailand

    Site Not Available

  • Research Site

    Adana, 01060
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Adana 325363, 01060
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Adapazarı, 54290
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Adapazarı 752850, 54290
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kahramanmaraş, 46040
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Kahramanmaraş 310859, 46040
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kayseri, 38039
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Kayseri 308464, 38039
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kocaeli, 41380
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Kocaeli 306970, 41380
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kyiv, 01601
    Ukraine

    Active - Recruiting

  • Research Site

    Kyiv 703448, 02002
    Ukraine

    Site Not Available

  • Research Site

    Uzhhorod, 88018
    Ukraine

    Active - Recruiting

  • Research Site

    Uzhhorod 690548, 88018
    Ukraine

    Site Not Available

  • Research Site

    Vinnytsia, 21029
    Ukraine

    Active - Recruiting

  • Research Site

    Vinnytsia 689558, 21029
    Ukraine

    Site Not Available

  • Research Site

    Dundee, DD1 9SY
    United Kingdom

    Active - Recruiting

  • Research Site

    Dundee 2650752, DD1 9SY
    United Kingdom

    Site Not Available

  • Research Site

    Liverpool, L9 7AL
    United Kingdom

    Active - Recruiting

  • Research Site

    Liverpool 2644210, L9 7AL
    United Kingdom

    Site Not Available

  • Research Site

    London, E1 1FR
    United Kingdom

    Active - Recruiting

  • Research Site

    London 2643743, E1 1FR
    United Kingdom

    Site Not Available

  • Research Site

    Surprise, Arizona 85374
    United States

    Active - Recruiting

  • Research Site

    Surprise 5316428, Arizona 5551752 85374
    United States

    Site Not Available

  • Research Site

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Research Site

    Port Charlotte, Florida 33952
    United States

    Active - Recruiting

  • Research Site

    Port Orange, Florida 32127
    United States

    Active - Recruiting

  • Research Site

    Hollywood 4158928, Florida 4155751 33021
    United States

    Site Not Available

  • Research Site

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Site Not Available

  • Research Site

    Port Orange 4169156, Florida 4155751 32127
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30344
    United States

    Active - Recruiting

  • Research Site

    Atlanta 4180439, Georgia 4197000 30344
    United States

    Site Not Available

  • Research Site

    Champaign, Illinois 61822
    United States

    Active - Recruiting

  • Research Site

    Champaign 4887158, Illinois 4896861 61822
    United States

    Site Not Available

  • Research Site

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Research Site

    Wichita 4281730, Kansas 4273857 67214
    United States

    Site Not Available

  • Research Site

    Eatontown, New Jersey 07724
    United States

    Active - Recruiting

  • Research Site

    Eatontown 5097482, New Jersey 5101760 07724
    United States

    Site Not Available

  • Research Site

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, North Carolina 28546
    United States

    Active - Recruiting

  • Research Site

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Research Site

    Greenville 4469160, North Carolina 4482348 27834
    United States

    Site Not Available

  • Research Site

    Jacksonville 4473083, North Carolina 4482348 28546
    United States

    Site Not Available

  • Research Site

    New Bern 4481682, North Carolina 4482348 28562
    United States

    Site Not Available

  • Research Site

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • Research Site

    Columbus 4509177, Ohio 5165418 43215
    United States

    Site Not Available

  • Research Site

    Media, Pennsylvania 19063
    United States

    Active - Recruiting

  • Research Site

    Chester 4557137, Pennsylvania 6254927 19013
    United States

    Site Not Available

  • Research Site

    Media 4559575, Pennsylvania 6254927 19063
    United States

    Site Not Available

  • Research Site

    East Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Research Site

    East Providence 5221931, Rhode Island 5224323 02914
    United States

    Site Not Available

  • Research Site

    Arlington, Texas 76015
    United States

    Active - Recruiting

  • Research Site

    Pasadena, Texas 77504
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • Research Site

    Arlington 4671240, Texas 4736286 76015
    United States

    Site Not Available

  • Research Site

    Pasadena 4717782, Texas 4736286 77504
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78212
    United States

    Site Not Available

  • Research Site

    Woodbridge, Virginia 22192
    United States

    Active - Recruiting

  • Research Site

    Woodbridge 4794457, Virginia 6254928 22192
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.