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Baxdrostat and Dapagliflozin for Chronic Kidney Disease and High Blood Pressure

This study is testing if a combination of two medicines, baxdrostat and dapagliflozin, is better than dapagliflozin alone for people with chronic kidney disease (CKD) and high blood pressure. Researchers want to see if this combination can reduce the risk of kidney problems getting worse, heart failure, or death from heart-related issues. You might be able to join if you are 18 or older, have CKD with a specific kidney function (eGFR between 30-59 mL/min/1.73 m²) and a certain level of protein in your urine (UACR ≥ 30 mg/g). The study plans to enroll 5000 participants. The current recruitment status is unclear.

Study design
This is an international, multi-center, double-blind, placebo-controlled study. This means neither you nor your doctor will know if you are receiving baxdrostat/dapagliflozin or placebo/dapagliflozin.
What's involved
You will have a 4-week run-in period with dapagliflozin if you are not already taking it. After that, you will have study visits at 2, 4, 8, 16, 34, and 52 weeks, and then approximately every 4 months.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study is measured up to 37 months. You will have a final safety visit within 6 weeks after the study reaches a certain number of events.

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NCT06742723

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

Recruiting
PHASE3Ages 18+InterventionalTreatment
AstraZeneca
~5,000 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Baxdrostat/dapagliflozinPlacebo/dapagliflozin

At a glance

Recruiting sites
664 of 771 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death.
Measured over Up to 37 months

Conditions

Chronic Kidney Disease and Hypertension

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Where it's being run

771 sites across 82 states
Japan63
China62
Poland37
Germany35
France25
Argentina22
Bulgaria20
Ukraine19

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or
UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).
UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or
UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only) 3. \[obsolete\] 4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit. 5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit. 6. Participants with:

What this trial measures

  • To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death.Up to 37 months

    Time to the first occurrence of any of the components of the composite of: Kidney disease progression * ≥ 50% sustained decline in eGFR * Onset of kidney failure: * Sustained eGFR \< 15 mL/min/1.73 m2 or * Chronic dialysis treatment or * Receiving a kidney transplant or * Death with a renal primary cause (death due to kidney failure when dialysis is not given) CV events * HF with or without hospitalisation * CV death