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.
NCT ID: NCT07222917
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
218 participants
INTERVENTIONAL
2025-12-05
2027-05-24
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
The following personnel will be unblinded:
* Personnel carrying out the packaging and labelling of study intervention treatment
* Personnel generating the randomisation list
Participants, site personnel, and AstraZeneca will be blinded to study intervention. AstraZeneca retains the right to break the code for SAEs that are unexpected and are suspected to be causally related to study intervention and that potentially require expedited reporting to regulatory authorities. Randomisation codes will not be broken for the planned analyses of data until all decisions on the evaluability of the data from each individual participant have been made and documented.
Study Groups
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Baxdrostat/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
Baxdrostat /placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily
Baxdrostat/Placebo
baxdrostat tablet
placebo tablet
Interventions
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Baxdrostat/dapagliflozin
baxdrostat tablet
dapagliflozin tablet
Baxdrostat/Placebo
baxdrostat tablet
placebo tablet
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Surprise, Arizona, United States
Research Site
Hollywood, Florida, United States
Research Site
Port Charlotte, Florida, United States
Research Site
Port Orange, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Champaign, Illinois, United States
Research Site
Wichita, Kansas, United States
Research Site
Eatontown, New Jersey, United States
Research Site
Greenville, North Carolina, United States
Research Site
Jacksonville, North Carolina, United States
Research Site
New Bern, North Carolina, United States
Research Site
Columbus, Ohio, United States
Research Site
Media, Pennsylvania, United States
Research Site
East Providence, Rhode Island, United States
Research Site
Arlington, Texas, United States
Research Site
Pasadena, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Woodbridge, Virginia, United States
Research Site
Buenos Aires, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
Research Site
Mar del Plata, , Argentina
Research Site
San Nicolás, , Argentina
Research Site
Pernik, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Yambol, , Bulgaria
Research Site
Courtice, Ontario, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Stouffville, Ontario, Canada
Research Site
Waterloo, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Anyang-si, , South Korea
Research Site
Cheonan-si, , South Korea
Research Site
Goyang-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Badalona, , Spain
Research Site
Pamplona, , Spain
Research Site
Valencia, , Spain
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
New Taipei City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Bangkoknoi, , Thailand
Research Site
Changwat Sara Buri, , Thailand
Research Site
Hat Yai, , Thailand
Research Site
Muang, , Thailand
Research Site
Ratchathewi, , Thailand
Research Site
Adana, , Turkey (Türkiye)
Research Site
Adapazarı, , Turkey (Türkiye)
Research Site
Kahramanmaraş, , Turkey (Türkiye)
Research Site
Kayseri, , Turkey (Türkiye)
Research Site
Kocaeli, , Turkey (Türkiye)
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Dundee, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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D6972C00006
Identifier Type: -
Identifier Source: org_study_id
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