The goal of this clinical trial is to find out whether treatment with baxdrostat changes aldosterone-producing activity in the adrenal glands of people with primary aldosteronism. The study will use specialised imaging to measure changes in the adrenal glands before and after treatment.
Participants will receive baxdrostat for 24 weeks and will be followed for changes in their adrenal imaging, blood pressure and hormone levels. The study will also investigate whether changes caused by treatment continue after baxdrostat is stopped.
This is a single-group study, meaning that all participants receive baxdrostat and there is no placebo or comparison group.
Male or female
Age > 18 years at time of signing informed consent.
Diagnosed with Primary Aldosteronism (PA) according to Endocrine Society guidelines
Presence of one or more adrenal nodules, (diameter 0.5-2.5 cm) on CT, PET-CT, or MRI, with characteristics (e.g. washout) of adenomas
<18 years of age
Current or prior treatment (within 1 month before screening) with angiotensin-receptor blockers in combination with ACEIs.
Serum sodium level < 135 mmol/L at screening, determined as per central laboratory.
The following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
Single group
baxdrostat
DrugBaxdrostat 2 mg administered orally once daily for 24 weeks as an aldosterone synthase inhibitor. Treatment begins after the baseline \[18F\]-CETO PET-CT has confirmed eligibility for study treatment.
Change in total lesion uptake of [18F]-CETO in adrenal lesions
Change, between pre- and post-baxdrostat PET-CT images, in total \[18F\]-CETO-positive lesion uptake, calculated by multiplying the volume (ml) of each lesion by its mean standardised uptake value (SUVmean) (unitless) and summing these values across all lesions. SUVmean is a dimensionless ratio of measured to injected radioactivity. This calculation generates a single reported value, expressed in SUV·ml, the conventional unit for this measurement. \[Each lesion will be defined according to the 2025 European Association of Nuclear Medicine guideline.\]
Change in SUVmax between pre- and post-baxdrostat PET-CT images
Change, between pre- and post-baxdrostat PET-CT images, in maximum standardised uptake value (SUVmax) (unitless) of individual \[18F\]-CETO-positive lesions. SUVmax is a dimensionless ratio of measured to administered radioactivity. Where more than one lesion is present, SUVmax will be measured separately for each lesion and the values averaged to provide a single participant-level result.
Voxel level change between pre- and post-baxdrostat PET-CT images
Voxel-level change in standardised uptake value (SUV) (unitless) between corresponding voxels across \[18F\]-CETO-positive lesions in pre- and post-baxdrostat PET-CT images. Pre- and post-treatment images will be registered to permit comparison of corresponding voxels, and the mean difference in SUV between paired voxels will be reported. SUV is a dimensionless ratio of measured to injected radioactivity.
Change in the individual components of the primary endpoint: 1. Volume
Change, between pre- and post-baxdrostat PET-CT images, in total volume (ml) of all \[18F\]-CETO-positive lesions. Where more than one lesion is present, individual lesion volumes will be summed to generate a single reported value.
Change in the individual components of the primary endpoint - 2. mean SUV
Change, between pre- and post-baxdrostat PET-CT images, in mean standardised uptake value (SUVmean) (unitless) across all \[18F\]-CETO-positive lesions. Where more than one lesion is present, a single overall SUVmean will be calculated across all lesions. SUVmean is a dimensionless ratio of measured to injected radioactivity.
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Queen Mary University of London
Lead sponsor
AstraZeneca
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
