Chronic Kidney Disease and HypertensionPhase 2BaxDuo-BalticNCT07222917
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 2 study testing Baxdrostat/dapagliflozin in people with Chronic Kidney Disease and Hypertension, run by AstraZeneca at 55 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease and Hypertension
- What is being tested?
- Baxdrostat/dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 55 sitesin 9 countries
- Study dates
- 5 Dec 2025to 10 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
- Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
- Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
- 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.
- Participants with:
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- Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
- Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
- Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.
Who cannot join
- 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)
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- 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.
- Any dialysis (including for acute kidney injury) within 3 months prior to the screening
- Any acute kidney injury within 3 months prior to the screening visit.
- Prohibited concomitant medications
Trial locations and contacts
55 sites in 9 countries.
55 sites in 9 countries
United States17 sites
Research Site
Arlington, Texas, 76015
Research Site
Champaign, Illinois, 61822
Research Site
Columbus, Ohio, 43215
Research Site
East Point, Georgia, 30344
Research Site
East Providence, Rhode Island, 02914
Research Site
Greenville, North Carolina, 27834
Research Site
Hollywood, Florida, 33021
Research Site
Jacksonville, North Carolina, 28546
Research Site
Media, Pennsylvania, 19063
Research Site
New Bern, North Carolina, 28562
Research Site
Pasadena, Texas, 77504
Research Site
Port Charlotte, Florida, 33952
Research Site
Port Orange, Florida, 32127
Research Site
San Antonio, Texas, 78212
Research Site
Surprise, Arizona, 85374
Research Site
Wichita, Kansas, 67214
Research Site
Woodbridge, Virginia, 22192
Taiwan8 sites
Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 83301
Research Site
New Taipei City, 235
Research Site
Taichung, 402
Research Site
Taichung, 433004
Research Site
Taipei, 10002
Research Site
Taipei, 110
Research Site
Taoyuan, 333
Ukraine8 sites
Research Site
Kyiv, 01601
Research Site
Kyiv, 02002
Research Site
Kyiv, 02091
Research Site
Kyiv, 03037
Research Site
Kyiv, 03049
Research Site
Kyiv, 04210
Research Site
Uzhhorod, 88018
Research Site
Vinnytsia, 21029
Turkey (Türkiye)5 sites
Research Site
Adana, 01060
Research Site
Adapazarı, 54290
Research Site
Kahramanmaraş, 46040
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380
Argentina4 sites
Research Site
Ciudad de Buenos Aires, C1425AGC
Research Site
Mar del Plata, 7600
Research Site
Rosario, S2000CVD
Research Site
San Nicolás, B2900DMH
Canada4 sites
Research Site
Courtice, Ontario, L1E 2J5
Research Site
Etobicoke, Ontario, M9W 6V1
Research Site
Stouffville, Ontario, L4A1H2
Research Site
Waterloo, Ontario, N2T 0C1
Thailand4 sites
Research Site
Bangkoknoi, 10700
Research Site
Changwat Sara Buri, 18000
Research Site
Hat Yai, 90110
Research Site
Ratchathewi, 10400
United Kingdom3 sites
Research Site
Dundee, DD1 9SY
Research Site
Liverpool, L9 7AL
Research Site
London, E1 1FR
About this study
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.
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.
Read the 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 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.
- Conditions
- Chronic Kidney Disease and Hypertension
- Being tested
- Baxdrostat/dapagliflozin, Baxdrostat/Placebo
- Keywords
- Chronic kidney disease, Hypertension, Blood pressure, Baxdrostat, Dapagliflozin
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baxdrostat/dapagliflozinDrug
baxdrostat tablet
dapagliflozin tablet
Baxdrostat/PlaceboDrug
baxdrostat tablet
placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Baxdrostat/dapagliflozin | Experimental | Participants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily. Receives: Drug: Baxdrostat/dapagliflozin |
| Baxdrostat /placebo | Placebo comparator | Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily Receives: Drug: Baxdrostat/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start5 Dec 2025
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease and HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, multicentre, randomised, double-blind, parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222917
- Sponsor's protocol ID
- D6972C00006
- Acronym
- BaxDuo-Baltic
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07222917
- Acronym / sponsor ID
- BaxDuo-Baltic / D6972C00006
- Conditions
- Chronic Kidney Disease and Hypertension
- Keywords
- Chronic kidney disease, Hypertension, Blood pressure, Baxdrostat, Dapagliflozin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 222 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 30 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional, multicentre, randomised, double-blind, parallel group
| Arm | Type | Receives |
|---|---|---|
| Baxdrostat/dapagliflozin | Experimental | Drug: Baxdrostat/dapagliflozinParticipants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily. |
| Baxdrostat /placebo | Placebo comparator | Drug: Baxdrostat/PlaceboPatients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
- Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
- Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
- 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.
Key exclusion criteria (14 listed)
- 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:
- New York Heart Association functional HF class IV at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baxdrostat/dapagliflozinbaxdrostat tablet dapagliflozin tablet | Drug | Baxdrostat/dapagliflozin |
| Baxdrostat/Placebobaxdrostat tablet placebo tablet | Drug | Baxdrostat /placebo |
Primary outcome
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Time frame: Up to 12 weeks
Change from baseline in UACR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
55 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baxdrostat/dapagliflozin in people with Chronic Kidney Disease and Hypertension, run by AstraZeneca at 55 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Taiwan, Ukraine, Turkey (Türkiye), Argentina and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria. (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.