Clinical trial NCT07007793: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Primary Hyperaldosteronism
Keywords: Primary hyperaldosteronism
Primary aldosteronism
PA
Baxdrostat
CIN-107
Aldosterone
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and unsuppression of Plasma Renin Activity (PRA) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.

Baxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks to based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and approximately 12 countries.


Eligibility criteria: Inclusion Criteria:

* Male or female participants must be ≥ 18 years of age
* Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
* Participants willing and able to cease dosing of MRA orpotassium sparing diuretics per study requirement for participantstaking an MRA or potassium sparing diuretic at Screening.
* eGFR ≥ 45 mL/min/1.73m2 at Screening
* Serum potassium level ≥ 3.0 and \< 5.0 mmol/L at Screeningdetermined as per the central laboratory.
* Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
* Mean seated SBP on AOBPM of ≥ 135 mmHg.

Exclusion Criteria:

- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 170 mmHg or mean seated DBP ≥110 mmHg (on AOBPM).

If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 160 mmHg or mean seated DBP ≥ 100 mmHg.

* Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.
* Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
* Serum sodium level \< 135 mmol/L at Screening, determined as per central laboratory.
* New York Heart Association functional HF class IV at Screening.
* Persistent atrial fibrillation.
* Treatment with any MRA or potassium-sparing diuretic within 2weeks prior to Randomisation.

Primary outcomes:
measure: Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8
timeFrame: At week 8
measure: Achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8
timeFrame: At week 8
Secondary outcomes:
measure: Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52
timeFrame: At week 52
measure: Percent change from RWD baseline (Week 44) in Plasma Renin Activity (PRA) at Week 52
timeFrame: At week 52
measure: Achieving serum potassium ≥ 3.7 mmol/L without potassium supplementation at Week 8 in participants with serum potassium < 3.7 mmol/L or potassium supplementation at baseline
timeFrame: At week 8
measure: Percent change from baseline in PRA at Week 8
timeFrame: At week 8
measure: Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline
timeFrame: At week 8
measure: Change from baseline in 24-hour urine albumin at Week 8
timeFrame: At week 8
Other outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: up to 54 weeks
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Berlin
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Kaiserslautern
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Reinfeld (Holstein)
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
Study officials:
References: