Effect of Baxdrostat and Dapagliflozin Combination Therapy versus Baxdrostat Monotherapy on Albuminuria in Patients with Chronic Kidney Disease and Hypertension
- Trial ID
- 2025-522407-23-00
- Protocol
- D6972C00006
- Sponsor
- AstraZeneca AB
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate whether the combination of baxdrostat and dapagliflozin is superior to baxdrostat monotherapy in reducing albuminuria in participants diagnosed with chronic kidney disease and hypertension. This assessment is clinically significant for determining the efficacy of dual pharmacological intervention in managing renal complications associated with elevated blood pressure.
Participants
This clinical trial involves 190 patients of any sex or gender. The study population consists of adults within specific age ranges who present with chronic kidney disease and hypertension. Inclusion requires an estimated glomerular filtration rate (eGFR) between 30 and 90 mL/min/1.73 m2 and a urinary albumin-to-creatinine ratio (UACR) greater than 200 mg/g and less than 5000 mg/g. Participants must have a history of hypertension with a systolic blood pressure (SBP) of at least 130 mmHg at screening and at least 120 mmHg at randomization. Additionally, subjects must be on a stable, maximum tolerated dose of either an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) for at least four weeks. Specific serum potassium levels are required based on the eGFR status, and female participants must utilize consistent contraception.
Plans and Procedures
This Phase IIb, randomised, multicentre, double-blind study is designed to evaluate the efficacy of baxdrostat in combination with dapagliflozin compared to baxdrostat alone in reducing albuminuria. The study involves participants with chronic kidney disease and hypertension. Following a screening visit to assess eligibility based on criteria such as estimated glomerular filtration rate (eGFR), urinary albumin-to-creatinine ratio (UACR), and systolic blood pressure, eligible participants will undergo randomisation. The primary endpoint is the change from baseline in UACR at Week 12. The study compares the combination of baxdrostat and dapagliflozin against baxdrostat plus a placebo. The total trial duration is estimated to span from February 2026 to February 2027.
Treatment
The experimental medication baxdrostat is administered as an oral tablet. The specific dosage for this substance is not specified in the provided data.
The study includes dapagliflozin, administered as Forxiga 10 mg film-coated tablets via oral use. This test substance is utilized to evaluate its effects in combination with the experimental medication.
A placebo, identified as dapagliflozin placebo, is employed as a comparator treatment within the study design to assess the impact on albuminuria in participants with chronic kidney disease and high blood pressure.
Efficacy
The efficacy of the combination of baxdrostat and dapagliflozin will be evaluated in participants with chronic kidney disease and hypertension. The primary endpoint is the change from baseline in the urinary albumin-to-creatinine ratio (UACR) at week 12.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
- Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
- Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
- Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
- 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.
- Participants with: (a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2. (b) Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
- 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
- Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.
- Known hyperkalaemia, defined as potassium of ≥ 5.5mmol/L within 3 months before screening
- Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).
- Diabetes mellitus: (a) T1DM at the screening visit (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91mmol/mol)
- New York Heart Association functional HF class IV at screening
- Any use of mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders within 4 weeks prior to screening
- 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.
- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
- Documented history of adrenal insufficiency.
- Any dialysis (including for acute kidney injury) within 3 months prior to the screening
- Any acute kidney injury within 3 months prior to the screening visit.
- Prohibited concomitant medications
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Bulgaria | Not Recruiting | 19 Feb 2026 | 16 |
 Spain | Not Recruiting | 19 Feb 2026 | 12 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Forxiga 10 mg film-coated tablets | Test | FILM-COATED TABLETS | ORAL USE | 10 | 99 | PRD8495988 |
Baxdrostat | Test | TABLET | ORAL USE | 00 | 99 | PRD10361078 |
Dapagliflozin Placebo | Placebo | N/A | — | — | — | N/A |