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.

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by AstraZeneca
Sponsor
AstraZeneca
Information Provided by (Responsible Party)
AstraZeneca
Clinicaltrials.gov Identifier
NCT07222917
Other Study ID Numbers:
D6972C00006
First Submitted
October 16, 2025
First Posted
October 29, 2025
Last Update Posted
April 2, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

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.

Condition or DiseaseIntervention/Treatment
Chronic Kidney Disease and Hypertension
Drug: Baxdrostat/dapagliflozinDrug: Baxdrostat/Placebo

Study Design

Study TypeInterventional
Actual Enrollment218 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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.
Study Start DateDecember 4, 2025
Actual Primary Completion Date1yr 1mo from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Baxdrostat/dapagliflozin
Participants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily.
Drug: Baxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
Baxdrostat /placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily
Drug: Baxdrostat/Placebo
baxdrostat tablet placebo tablet

Outcome Measures

Primary Outcome Measures
  1. To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
    Change from baseline in UACR

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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.
Exclusion Criteria
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

Contacts and Locations

Sponsors and CollaboratorsAstraZeneca
Locations
Research Site | Surprise Arizona, United States, 85374Research Site | Hollywood Florida, United States, 33021Research Site | Port Charlotte Florida, United States, 33952Research Site | Port Orange Florida, United States, 32127Research Site | Atlanta Georgia, United States, 30344Research Site | Champaign Illinois, United States, 61822Research Site | Wichita Kansas, United States, 67214Research Site | Eatontown New Jersey, United States, 07724Research Site | Greenville North Carolina, United States, 27834Research Site | Jacksonville North Carolina, United States, 28546Research Site | New Bern North Carolina, United States, 28562Research Site | Columbus Ohio, United States, 43215Research Site | Media Pennsylvania, United States, 19063Research Site | East Providence Rhode Island, United States, 02914Research Site | Arlington Texas, United States, 76015Research Site | Pasadena Texas, United States, 77504Research Site | San Antonio Texas, United States, 78212Research Site | Woodbridge Virginia, United States, 22192Research Site | Buenos Aires , Argentina, C1060AABResearch Site | Ciudad de Buenos Aires , Argentina, C1425AGCResearch Site | Mar del Plata , Argentina, 7600Research Site | Rosario , Argentina, S2000CVDResearch Site | San Nicolás , Argentina, B2900DMHResearch Site | Pernik , Bulgaria, 2300Research Site | Plovdiv , Bulgaria, 4004Research Site | Sofia , Bulgaria, 1431Research Site | Sofia , Bulgaria, 1680Research Site | Sofia , Bulgaria, 1756Research Site | Sofia , Bulgaria, 1756Research Site | Yambol , Bulgaria, 8600Research Site | Courtice Ontario, Canada, L1E 2J5Research Site | Etobicoke Ontario, Canada, M9W 6V1Research Site | Stouffville Ontario, Canada, L4A1H2Research Site | Waterloo Ontario, Canada, N2T 0C1Research Site | Montreal Quebec, Canada, H4J 1C5Research Site | Anyang-si , South Korea, 14068Research Site | Cheonan-si , South Korea, 31151Research Site | Goyang-si , South Korea, 10380Research Site | Seoul , South Korea, 04401Research Site | Badalona , Spain, 08916Research Site | Pamplona , Spain, 31008Research Site | Valencia , Spain, 46010Research Site | Kaohsiung City , Taiwan, 80756Research Site | Kaohsiung City , Taiwan, 83301Research Site | New Taipei City , Taiwan, 235Research Site | Taichung , Taiwan, 402Research Site | Taichung , Taiwan, 433004Research Site | Taipei , Taiwan, 10002Research Site | Taipei , Taiwan, 110Research Site | Taoyuan District , Taiwan, 333Research Site | Bangkoknoi , Thailand, 10700Research Site | Changwat Sara Buri , Thailand, 18000Research Site | Hat Yai , Thailand, 90110Research Site | Muang , Thailand, 50200Research Site | Ratchathewi , Thailand, 10400Research Site | Adana , Turkey (Türkiye), 01060Research Site | Adapazarı , Turkey (Türkiye), 54290Research Site | Kahramanmaraş , Turkey (Türkiye), 46040Research Site | Kayseri , Turkey (Türkiye), 38039Research Site | Kocaeli , Turkey (Türkiye), 41380Research Site | Kyiv , Ukraine, 01601Research Site | Kyiv , Ukraine, 02002Research Site | Kyiv , Ukraine, 02091Research Site | Kyiv , Ukraine, 03037Research Site | Kyiv , Ukraine, 03049Research Site | Kyiv , Ukraine, 04210Research Site | Uzhhorod , Ukraine, 88018Research Site | Vinnytsia , Ukraine, 21029Research Site | Dundee , United Kingdom, DD1 9SYResearch Site | Liverpool , United Kingdom, L9 7ALResearch Site | London , United Kingdom, E1 1FR