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.

Study identifier:D6972C00003

ClinicalTrials.gov identifier:NCT06268873

EudraCT identifier:N/A

CTIS identifier:2023-506457-38-00

Recruiting

Official Title

A Phase III, Randomised, Double-Blind, Active-controlled Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure

Medical condition

Chronic kidney disease and hypertension

Phase

Phase 3

Healthy volunteers

Study drug

Baxdrostat/dapagliflozin, Dapagliflozin in combination with placebo

Sex

All

Estimated Enrollment

2500

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Mar 2024

Estimated Primary Completion Date: 10 Dec 2027

Estimated Study Completion Date: 10 Dec 2027

Study design

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

Verification:

Verified 01 Oct 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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:
o for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.5 and ≤ 4.8 mmol/L at the Screening Visit
o for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.5 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. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) at Screening.
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.

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Arms	Assigned Interventions
Experimental: Baxdrostat/dapagliflozin Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and 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
Active Comparator: Dapagliflozin Patients will receive one dose of dapagliflozin (active comparator) in combination with matching placebo daily	Drug: Dapagliflozin in combination with placebo dapagliflozin tablet placebo tablet

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]