Status:

ACTIVE_NOT_RECRUITING

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

Lead Sponsor:

AstraZeneca

Conditions:

Chronic Kidney Disease and Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflo...

Eligibility Criteria

Inclusion Criteria:

  1. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.

  2. Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening

  3. Urine albumin creatinine ratio > 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 tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit

  6. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:

    • for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
    • for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit

Exclusion Criteria:

  1. Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.

  2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.

  3. Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.

  4. Diabetes mellitus:

    (a) T1DM at Screening Visit: (i) For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.

    (ii) For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.

    (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol).

  5. New York Heart Association functional HF class IV at screening.

  6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.

  7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.

  8. Any acute kidney injury within 3 months prior to the Screening Visit

  9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).

  10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.

  11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.

  12. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), 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.

Key Trial Info

Start Date :

March 29 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 24 2028

Estimated Enrollment :

2554 Patients enrolled

Trial Details

Trial ID

NCT06268873

Start Date

March 29 2024

End Date

February 24 2028

Last Update

January 29 2026

Active Locations (564)

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Page 1 of 141 (564 locations)

1

Research Site

Fairhope, Alabama, United States, 36532

2

Research Site

Phoenix, Arizona, United States, 85016

3

Research Site

Surprise, Arizona, United States, 85374

4

Research Site

Tucson, Arizona, United States, 85710

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. | DecenTrialz