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A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. (BaxDuo-Baltic) Fase II 218 Doble ciego Internacional

Reclutando
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El ensayo clínico NCT07222917 (BaxDuo-Baltic) está diseñado para estudiar el tratamiento de Chronic Kidney Disease and Hypertension. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El estudio se inició el 5 de diciembre de 2025, con el objetivo de reclutar a 218 participantes. Dirigido por AstraZeneca, se espera que finalice el 24 de mayo de 2027. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de abril de 2026.
Resumen
International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.
Descripción detallada
This is a Phase IIb, randomised, multicentre, double-blind, parallel-group study aiming to determine the effect on albuminuria, as well as safety, of baxdrostat/dapagliflozin compared with baxdrostat/placebo, when given to participants with CKD and high blood pressure.

Study population will include participants ≥ 18 years old with CKD. Participants with or without a diagnosis of T2DM and with or without an SGLT2i tr...

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Título oficial

A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

Condiciones médicas
Chronic Kidney Disease and Hypertension
Otros ID del estudio
  • BaxDuo-Baltic
  • D6972C00006
Número del NCT
Inicio del estudio (real)
2025-12-05
Última actualización
2026-04-03
Fecha de finalización (estimada)
2027-05-24
Inscripción (prevista)
218
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
Chronic kidney disease
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalBaxdrostat/dapagliflozin
Participants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily.
Baxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
Comparador placeboBaxdrostat /placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily
Baxdrostat/Placebo
baxdrostat tablet placebo tablet
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
Up to 12 weeks
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.

  2. Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening

  3. Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening

  4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.

  5. Stable and maximum daily tolerated dose of either an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to the screening visit, if not medically contraindicated.

  6. Participants with:

    1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
    2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
  7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.

  1. Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.

  2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening

  3. Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).

  4. Diabetes mellitus:

    1. T1DM at the screening visit
    2. Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
  5. New York Heart Association functional HF class IV at screening

  6. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), aldosterone synthase inhibitors, potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening

  7. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening HF within previous 3 months prior to randomisation.

  8. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.

  9. Documented history of adrenal insufficiency.

  10. Any dialysis (including for acute kidney injury) within 3 months prior to the screening

  11. Any acute kidney injury within 3 months prior to the screening visit.

  12. Prohibited concomitant medications

AstraZeneca logoAstraZeneca
Contactos centrales del estudio
Contacto: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
71 Centros del estudio en 11 países
Research Site, Badalona, 08916, Spain
Retirado
Research Site, Pamplona, 31008, Spain
Retirado
Research Site, Valencia, 46010, Spain
Retirado
Research Site, Buenos Aires, C1060AAB, Argentina
Retirado
Research Site, Ciudad de Buenos Aires, C1425AGC, Argentina
Aún no recluta
Research Site, Mar del Plata, 7600, Argentina
Aún no recluta
Research Site, Rosario, S2000CVD, Argentina
Aún no recluta
Research Site, San Nicolás, B2900DMH, Argentina
Aún no recluta

Arizona

Research Site, Surprise, Arizona, 85374, United States
Reclutando

Florida

Research Site, Hollywood, Florida, 33021, United States
Reclutando
Research Site, Port Charlotte, Florida, 33952, United States
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Research Site, Port Orange, Florida, 32127, United States
Reclutando

Georgia

Research Site, Atlanta, Georgia, 30344, United States
Reclutando

Illinois

Research Site, Champaign, Illinois, 61822, United States
Reclutando

Kansas

Research Site, Wichita, Kansas, 67214, United States
Reclutando

New Jersey

Research Site, Eatontown, New Jersey, 07724, United States
Reclutando

North Carolina

Research Site, Greenville, North Carolina, 27834, United States
Reclutando
Research Site, Jacksonville, North Carolina, 28546, United States
Reclutando
Research Site, New Bern, North Carolina, 28562, United States
Reclutando

Ohio

Research Site, Columbus, Ohio, 43215, United States
Reclutando

Pennsylvania

Research Site, Media, Pennsylvania, 19063, United States
Reclutando

Rhode Island

Research Site, East Providence, Rhode Island, 02914, United States
Reclutando

Texas

Research Site, Arlington, Texas, 76015, United States
Reclutando
Research Site, Pasadena, Texas, 77504, United States
Reclutando
Research Site, San Antonio, Texas, 78212, United States
Reclutando

Virginia

Research Site, Woodbridge, Virginia, 22192, United States
Reclutando
Research Site, Pernik, 2300, Bulgaria
Retirado
Research Site, Plovdiv, 4004, Bulgaria
Retirado
Research Site, Sofia, 1431, Bulgaria
Retirado
Research Site, Sofia, 1680, Bulgaria
Retirado
Research Site, Sofia, 1756, Bulgaria
Retirado
Research Site, Sofia, 1756, Bulgaria
Aún no recluta
Research Site, Yambol, 8600, Bulgaria
Aún no recluta

Ontario

Research Site, Courtice, Ontario, L1E 2J5, Canada
Reclutando
Research Site, Etobicoke, Ontario, M9W 6V1, Canada
Reclutando
Research Site, Stouffville, Ontario, L4A1H2, Canada
Reclutando
Research Site, Waterloo, Ontario, N2T 0C1, Canada
Reclutando

Quebec

Research Site, Montreal, Quebec, H4J 1C5, Canada
Aún no recluta
Research Site, Anyang-si, 14068, South Korea
Retirado
Research Site, Cheonan-si, 31151, South Korea
Retirado
Research Site, Goyang-si, 10380, South Korea
Retirado
Research Site, Seoul, 04401, South Korea
Retirado
Research Site, Kaohsiung City, 80756, Taiwan
Reclutando
Research Site, Kaohsiung City, 83301, Taiwan
Reclutando
Research Site, New Taipei City, 235, Taiwan
Reclutando
Research Site, Taichung, 402, Taiwan
Reclutando
Research Site, Taichung, 433004, Taiwan
Reclutando
Research Site, Taipei, 10002, Taiwan
Reclutando
Research Site, Taipei, 110, Taiwan
Reclutando
Research Site, Taoyuan District, 333, Taiwan
Reclutando
Research Site, Bangkoknoi, 10700, Thailand
Reclutando
Research Site, Changwat Sara Buri, 18000, Thailand
Aún no recluta
Research Site, Hat Yai, 90110, Thailand
Reclutando
Research Site, Muang, 50200, Thailand
Aún no recluta
Research Site, Ratchathewi, 10400, Thailand
Aún no recluta
Research Site, Adana, 01060, Turkey (Türkiye)
Aún no recluta
Research Site, Adapazarı, 54290, Turkey (Türkiye)
Reclutando
Research Site, Kahramanmaraş, 46040, Turkey (Türkiye)
Reclutando
Research Site, Kayseri, 38039, Turkey (Türkiye)
Reclutando
Research Site, Kocaeli, 41380, Turkey (Türkiye)
Reclutando
Research Site, Kyiv, 01601, Ukraine
Reclutando
Research Site, Kyiv, 02002, Ukraine
Reclutando
Research Site, Kyiv, 02091, Ukraine
Reclutando
Research Site, Kyiv, 03037, Ukraine
Reclutando
Research Site, Kyiv, 03049, Ukraine
Reclutando
Research Site, Kyiv, 04210, Ukraine
Reclutando
Research Site, Uzhhorod, 88018, Ukraine
Reclutando
Research Site, Vinnytsia, 21029, Ukraine
Reclutando
Research Site, Dundee, DD1 9SY, United Kingdom
Activo, no reclutando
Research Site, Liverpool, L9 7AL, United Kingdom
Reclutando
Research Site, London, E1 1FR, United Kingdom
Reclutando