BAXDROSTAT for Chronic kidney disease|Hypertension

Inclusion criteria

• {"criterion_text":"- Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent."}
• {"criterion_text":"- Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening"}
• {"criterion_text":"- Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening"}
• {"criterion_text":"- Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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

• {"criterion_text":"- Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening."}
• {"criterion_text":"- Any dialysis (including for acute kidney injury) within 3 months prior to the screening"}
• {"criterion_text":"- Any acute kidney injury within 3 months prior to the screening visit."}
• {"criterion_text":"- Prohibited concomitant medications"}
• {"criterion_text":"- Known hyperkalaemia, defined as potassium of ≥ 5.5mmol/L within 3 months before screening"}
• {"criterion_text":"- Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit)."}
• {"criterion_text":"- Diabetes mellitus: (a) T1DM at the screening visit (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91mmol/mol)"}
• {"criterion_text":"- New York Heart Association functional HF class IV at screening"}
• {"criterion_text":"- Any use of mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders within 4 weeks prior to screening"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history."}
• {"criterion_text":"- Documented history of adrenal insufficiency."}

Primary endpoints

• {"endpoint_text":"- Change from baseline in UACR at Week 12","definition_or_measurement_approach":"Change from baseline in UACR at Week 12 (UACR measured at Week 12 compared with baseline)."}

Bulgaria

Earliest CTIS Part Ii Submission Date

21-10-2025

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

118

Number Of Sites

7

Number Of Participants

16

Spain

Earliest CTIS Part Ii Submission Date

15-01-2026

Latest Decision Or Authorization Date

16-02-2026

Processing Time Days

32

Number Of Sites

4

Number Of Participants

12

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden