Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-21 @ 5:57 AM
Study NCT ID:
NCT07007793
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-02-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-09', 'studyFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'up to 54 weeks', 'description': 'To assess the safety and tolerability of baxdrostat. Occurrence of Adverse Events (AEs), Serious Adverse Events (SAEs), deaths, AEs leading to discontinuation of IMP and adverse events of special interest (AESIs) (hyperkalemia and hyponatremia)'}], 'primaryOutcomes': [{'measure': 'Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8', 'timeFrame': 'At week 8', 'description': 'To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 8'}, {'measure': 'Achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8', 'timeFrame': 'At week 8', 'description': 'To assess the effect of baxdrostat versus placebo on achieving normalization of the Renin Angiotensin Aldosterone system (RAAS) at week 8, in participants with dysregulated RAAS at baseline'}], 'secondaryOutcomes': [{'measure': 'Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52', 'timeFrame': 'At week 52', 'description': 'To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) 8 weeks after Randomised withdrawal (RWD)'}, {'measure': 'Percent change from RWD baseline (Week 44) in Plasma Renin Activity (PRA) at Week 52', 'timeFrame': 'At week 52', 'description': 'To assess the effect of baxdrostat versus placebo on the percent change in PRA 8 weeks after RWD'}, {'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', 'description': 'To assess the effect of baxdrostat versus placebo on 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'}, {'measure': 'Percent change from baseline in PRA at Week 8', 'timeFrame': 'At week 8', 'description': 'To assess the effect of baxdrostat versus placebo on the percent change from baseline in PRA 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', 'description': 'To assess the effect of baxdrostat versus placebo on achieving 24-hour urine aldosterone \\< 10 μg at Week 8 in participants with 24-hour urine aldosterone\n\n≥ 10 μg at baseline'}, {'measure': 'Change from baseline in 24-hour urine albumin at Week 8', 'timeFrame': 'At week 8', 'description': 'To assess the effect of baxdrostat versus placebo on 24-hour urine albumin at Week 8'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary hyperaldosteronism', 'Primary aldosteronism', 'PA', 'Baxdrostat', 'CIN-107', 'Aldosterone'], 'conditions': ['Primary Hyperaldosteronism']}, 'descriptionModule': {'briefSummary': '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.\n\nBaxdrostat (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants must be ≥ 18 years of age\n* Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.\n* 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.\n* eGFR ≥ 45 mL/min/1.73m2 at Screening\n* Serum potassium level ≥ 3.0 and \\< 5.0 mmol/L at Screeningdetermined as per the central laboratory.\n* Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation\n* Mean seated SBP on AOBPM of ≥ 135 mmHg.\n\nExclusion Criteria:\n\n\\- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \\> 170 mmHg or mean seated DBP ≥110 mmHg (on AOBPM).\n\nIf taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \\> 160 mmHg or mean seated DBP ≥ 100 mmHg.\n\n* 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.\n* 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.\n* Serum sodium level \\< 135 mmol/L at Screening, determined as per central laboratory.\n* New York Heart Association functional HF class IV at Screening.\n* Persistent atrial fibrillation.\n* Treatment with any MRA or potassium-sparing diuretic within 2weeks prior to Randomisation."}, 'identificationModule': {'nctId': 'NCT07007793', 'acronym': 'BaxPA', 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'DRUG', 'description': 'Placebo tablet matching baxdrostat, administered orally, once daily (QD).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62702', 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