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 - BaxDuo-Pacific

Study identifier:D6972C00002

ClinicalTrials.gov identifier:NCT06742723

EudraCT identifier:N/A

CTIS identifier:2023-506460-14-00

Recruiting

Official Title

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants with Chronic Kidney Disease and High Blood Pressure

Medical condition

Chronic kidney disease and hypertension

Phase

Phase 3

Healthy volunteers

Study drug

Baxdrostat/dapagliflozin, Placebo/dapagliflozin

Sex

All

Estimated Enrollment

5000

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 03 Mar 2025

Estimated Primary Completion Date: 18 Apr 2030

Estimated Study Completion Date: 18 Apr 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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:
a) eGFR ≥ 30 and < 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
b) eGFR ≥ 30 and ≤ 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) or UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local or central laboratory values).
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:
a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values).
b) Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values).

Exclusion Criteria

1 Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.
2 Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.
3 Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
4. T1DM:
a) 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.
b) 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.
5 Uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).
6 New York Heart Association functional HF class IV at screening.
7 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.
8 Documented history of adrenal insufficiency.
9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
10 Any acute kidney injury within 3 months prior to the Screening Visit.
11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).

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Arms	Assigned Interventions
Experimental: Baxdrostat/dapagliflozin Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.	Drug: Baxdrostat/dapagliflozin baxdrostat tablet dapagliflozin tablet Other Name: Baxdrostat CIN-107
Placebo Comparator: Placebo/dapagliflozin Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.	Drug: Placebo/dapagliflozin dapagliflozin tablet placebo tablet

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]