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 (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND: - UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory value), or - UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or - UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only). (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND: - UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or - UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)"}
• {"criterion_text":"- Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at Screening visit) and ≥ 120 mmHg at the randomisation visit"}
• {"criterion_text":"- Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit."}
• {"criterion_text":"- 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

• {"criterion_text":"- Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening."}
• {"criterion_text":"- Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening."}
• {"criterion_text":"- Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit."}
• {"criterion_text":"- Serum sodium < 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit)."}
• {"criterion_text":"- Participants with T1DM will be excluded, except: 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- New York Heart Association functional HF class IV at 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 heart failure within previous 3 months prior to randomisation."}
• {"criterion_text":"- Documented history of adrenal insufficiency."}
• {"criterion_text":"- History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant)."}
• {"criterion_text":"- Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1)."}
• {"criterion_text":"- Any acute kidney injury within 3 months prior to the Screening Visit."}

Primary endpoints

• {"endpoint_text":"- 1. Time to the first occurrence of any of the components of the composite of: • Kidney disease progression • ≥ 50% sustained decline in eGFR • Onset of kidney failure: - Sustained eGFR < 15 mL/min/1.73 m2 or - Chronic dialysis treatment or - Receiving a kidney transplant or - Death with a renal primary cause (death due to kidney failure when dialysis is not given) • CV events • HF with or without hopsitalization • CV death","definition_or_measurement_approach":"Time-to-event analysis: time from randomisation to first occurrence of any component of the composite endpoint (components defined in the endpoint text, including ≥50% sustained decline in eGFR, onset of kidney failure defined as sustained eGFR <15 mL/min/1.73 m2 or chronic dialysis or kidney transplant or death due to renal cause; CV events including HF events; CV death)."}

Secondary endpoints

• {"endpoint_text":"- 1. Time to the first occurrence of any of the components of the composite of: • ≥ 50% sustained decline in eGFR • Onset of kidney failure: - Sustained eGFR < 15 mL/min/1.73 m2 or - Chronic dialysis treatment or - Receiving a kidney transplant or - Death with a renal primary cause (death due to kidney failure when dialysis is not given) • CV death","definition_or_measurement_approach":"Time-to-event: time from randomisation to first occurrence of any listed component (≥50% sustained decline in eGFR; onset of kidney failure as defined; CV death)."}
• {"endpoint_text":"- 2. Time to the first occurrence of any of the components of the composite of: • CV death • HF with or without hospitalization • MI • stroke","definition_or_measurement_approach":"Time-to-event: time from randomisation to first occurrence of major adverse cardiovascular events (MACE components: CV death, HF events ± hospitalisation, MI, stroke)."}
• {"endpoint_text":"- 3. CV death","definition_or_measurement_approach":"Time-to-event: time from randomisation to cardiovascular death."}
• {"endpoint_text":"- 4. Time to all-cause death","definition_or_measurement_approach":"Time-to-event: time from randomisation to death from any cause."}

Methods

• Posters (local and hospital posters) - documents titled with 'Poster' or 'K2_Recruitment material Poster'.
• Pamphlets / Leaflets (patient-facing pamphlets) - documents titled 'Pamphlet' or 'Leaflet' (country-specific versions present).
• Patient association engagement / letters to patient associations (documents titled 'patient association letter').
• Hospital/clinic letters to patients / hospital recruitment letters (documents titled 'hospital letter').
• Local advertisements / website text (documents titled 'Local advertisement' and 'text website').
• Social media recruitment (documents titled 'social media slogans' and 'social media images').
• Pre-screening telephone calls and prescreening materials (documents titled 'Prescreening ICF Summary' and 'Pre-screening ICF Summary').
• General practitioner (GP) and nurse communications (documents titled 'general practicioner letter' and 'nurses letter').
• Recruitment plan and communications package documents (documents titled 'recruitment plan' and 'Recruitment and Communications Package').

Primary sponsor

Full Name

Astrazeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden