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New combo pill aims to protect kidneys in High-Risk patients

NCT ID NCT07222917

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study tests whether adding dapagliflozin to baxdrostat reduces protein in the urine (a sign of kidney damage) better than baxdrostat alone. About 218 adults with chronic kidney disease and high blood pressure will take either the combo or baxdrostat plus a placebo. The goal is to see if the combination offers extra kidney protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
baxdrostat and dapagliflozin
What this could lead to
If successful, this combination could offer a new way to reduce kidney damage in people with chronic kidney disease and high blood pressure.
What could go wrong
This is a phase IIb trial with only 218 participants, so results are preliminary. The added benefit of dapagliflozin over baxdrostat alone may be small or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

222 people

The number who actually took part.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease and hypertension

Contacts and locations

Locations

  • Research Site

    Surprise, Arizona, 85374, United States

  • Research Site

    Hollywood, Florida, 33021, United States

  • Research Site

    Port Charlotte, Florida, 33952, United States

  • Research Site

    Port Orange, Florida, 32127, United States

  • Research Site

    East Point, Georgia, 30344, United States

  • Research Site

    Champaign, Illinois, 61822, United States

  • Research Site

    Wichita, Kansas, 67214, United States

  • Research Site

    Greenville, North Carolina, 27834, United States

  • Research Site

    Jacksonville, North Carolina, 28546, United States

  • Research Site

    New Bern, North Carolina, 28562, United States

  • Research Site

    Columbus, Ohio, 43215, United States

  • Research Site

    Media, Pennsylvania, 19063, United States

  • Research Site

    East Providence, Rhode Island, 02914, United States

  • Research Site

    Arlington, Texas, 76015, United States

  • Research Site

    Pasadena, Texas, 77504, United States

  • Research Site

    San Antonio, Texas, 78212, United States

  • Research Site

    Woodbridge, Virginia, 22192, United States

  • Research Site

    Ciudad de Buenos Aires, C1425AGC, Argentina

  • Research Site

    Mar del Plata, 7600, Argentina

  • Research Site

    Rosario, S2000CVD, Argentina

  • Research Site

    San Nicolás, B2900DMH, Argentina

  • Research Site

    Sofia, 1756, Bulgaria

  • Research Site

    Yambol, 8600, Bulgaria

  • Research Site

    Courtice, Ontario, L1E 2J5, Canada

  • Research Site

    Etobicoke, Ontario, M9W 6V1, Canada

  • Research Site

    Stouffville, Ontario, L4A1H2, Canada

  • Research Site

    Waterloo, Ontario, N2T 0C1, Canada

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    New Taipei City, 235, Taiwan

  • Research Site

    Taichung, 402, Taiwan

  • Research Site

    Taichung, 433004, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkoknoi, 10700, Thailand

  • Research Site

    Changwat Sara Buri, 18000, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Ratchathewi, 10400, Thailand

  • Research Site

    Adana, 01060, Turkey (Türkiye)

  • Research Site

    Adapazarı, 54290, Turkey (Türkiye)

  • Research Site

    Kahramanmaraş, 46040, Turkey (Türkiye)

  • Research Site

    Kayseri, 38039, Turkey (Türkiye)

  • Research Site

    Kocaeli, 41380, Turkey (Türkiye)

  • Research Site

    Kyiv, 01601, Ukraine

  • Research Site

    Kyiv, 02002, Ukraine

  • Research Site

    Kyiv, 02091, Ukraine

  • Research Site

    Kyiv, 03037, Ukraine

  • Research Site

    Kyiv, 03049, Ukraine

  • Research Site

    Kyiv, 04210, Ukraine

  • Research Site

    Uzhhorod, 88018, Ukraine

  • Research Site

    Vinnytsia, 21029, Ukraine

  • Research Site

    Dundee, DD1 9SY, United Kingdom

  • Research Site

    Liverpool, L9 7AL, United Kingdom

  • Research Site

    London, E1 1FR, United Kingdom

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