A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism

Официальное название

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism

Обзор

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 achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 250 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 based on clinical response and tolerability. The study is planned to be conducted globally in approximately 90 study centres and 12 countries.

Вмешательства

• Препарат Baxdrostat
  Baxdrostat tablet administered orally, once daily (QD).
• Препарат Placebo
  Placebo tablet matching baxdrostat, administered orally, once daily (QD).

Первичные конечные точки

• Change from baseline in seated Systolic Blood Pressure (SBP) at Week 8 [Срок оценки: At week 8]
• Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8. [Срок оценки: At week 8]

Вторичные конечные точки (6)

• Percent change from RWD baseline (Week 44) in Direct Renin Concentration (DRC) at Week 52 [Срок оценки: At week 52]
• Change from Randomised withdrawal (RWD) baseline (Week 44) in seated Systolic Blood Pressure (SBP) at Week 52 [Срок оценки: At week 52]
• Achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) at week 8. [Срок оценки: At week 8]
• 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 [Срок оценки: At week 8]
• Achieving 24-hour urine aldosterone < 10 μg at Week 8 in participants with 24-hour urine aldosterone ≥ 10 μg at baseline [Срок оценки: At week 8]
• Percent change from baseline in 24-hour urine albumin at Week 8 [Срок оценки: At week 8]

Критерии участия

Критерии включения

• 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 or potassium sparing diuretics per study requirement for participants taking 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 Screening determined 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 and ≤ 170 mmHg and mean DBP of

≤ 105 mmHg.

• Serum potassium (local lab) > 3.0 mmol/L at randomization.

Критерии исключения

\- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP > 170 mmHg or mean seated DBP >105 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 2 weeks prior to Randomisation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 21 центр

• Research Site — Los Angeles
• Research Site — San Francisco
• Research Site — Farmington
• Research Site — Chicago
• Research Site — Springfield
• Research Site — Baltimore
• Research Site — Boston
• Research Site — Boston
• … и ещё 13 центров

Китай · 13 центров

• Research Site — Пекин
• Research Site — Пекин
• Research Site — Пекин
• Research Site — Чанша
• Research Site — Чэнду
• Research Site — Чэнду
• Research Site — Чунцин
• Research Site — Нанкин
• … и ещё 5 центров

Франция · 7 центров

• Research Site — Amiens
• Research Site — Bois-Guillaume
• Research Site — Bordeaux
• Research Site — Lille
• Research Site — Marseille
• Research Site — Paris
• Research Site — Paris

Япония · 7 центров

• Research Site — Kawasaki-shi
• Research Site — Kodaira-shi
• Research Site — Minatoku
• Research Site — Ōta-ku
• Research Site — Shinjuku-ku
• Research Site — Yokohama
• Research Site — Yufu-shi

Германия · 6 центров

• Research Site — Berlin
• Research Site — Düsseldorf
• Research Site — Kaiserslautern
• Research Site — München
• Research Site — Reinfeld (Holstein)
• Research Site — Würzburg

Индия · 6 центров

• Research Site — Belagavi
• Research Site — Delhi
• Research Site — Hyderabad
• Research Site — Kolkata
• Research Site — Mumbai
• Research Site — Mumbai

Италия · 6 центров

• Research Site — Bologna
• Research Site — Brescia
• Research Site — Florence
• Research Site — Milan
• Research Site — Milan
• Research Site — Torino

Тайвань · 6 центров

• Research Site — Kaohsiung City
• Research Site — Taichung
• … и ещё 4 центра

Испания · 5 центров

• Research Site — Barcelona
• Research Site — Madrid
• Research Site — Madrid
• Research Site — Madrid
• Research Site — Seville

Великобритания · 5 центров

Список центров уточняется — проверьте первичный протокол.

Канада · 4 центра

• Research Site — Calgary
• Research Site — Ottawa
• Research Site — Toronto
• Research Site — Montreal

Австралия · 3 центра

• Research Site — Brisbane
• Research Site — Clayton
• Research Site — Perth

Идентификаторы

NCT: NCT07007793 · D6974C00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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