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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 Duplo-cego Internacional

Em recrutamento
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O estudo clínico NCT07222917 (BaxDuo-Baltic) procura avaliar tratamento para Chronic Kidney Disease and Hypertension. Este é um estudo intervencionista de Fase II. Seu status atual é: em recrutamento. O estudo começou em 5 de dezembro de 2025 e pretende incluir 218 participantes. Coordenado por AstraZeneca e deve ser concluído em 24 de maio de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de abril de 2026.
Resumo
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.
Descrição detalhada
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.

Condições médicas
Chronic Kidney Disease and Hypertension
Outros IDs do estudo
  • BaxDuo-Baltic
  • D6972C00006
Número NCT
Data de início (real)
2025-12-05
Última atualização postada
2026-04-03
Data de conclusão (estimada)
2027-05-24
Inscrição (estimada)
218
Tipo de estudo
Intervencionista
FASE
Fase II
Status
Em recrutamento
Palavras-chave
Chronic kidney disease
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Quádruplo-cego
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
Up to 12 weeks
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
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
Contato central do estudo
Contato: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
71 Locais do estudo em 11 países

Arizona

Research Site, Surprise, Arizona, 85374, United States
Em recrutamento

Florida

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

Georgia

Research Site, Atlanta, Georgia, 30344, United States
Em recrutamento

Illinois

Research Site, Champaign, Illinois, 61822, United States
Em recrutamento

Kansas

Research Site, Wichita, Kansas, 67214, United States
Em recrutamento

New Jersey

Research Site, Eatontown, New Jersey, 07724, United States
Em recrutamento

North Carolina

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

Ohio

Research Site, Columbus, Ohio, 43215, United States
Em recrutamento

Pennsylvania

Research Site, Media, Pennsylvania, 19063, United States
Em recrutamento

Rhode Island

Research Site, East Providence, Rhode Island, 02914, United States
Em recrutamento

Texas

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

Virginia

Research Site, Woodbridge, Virginia, 22192, United States
Em recrutamento
Research Site, Buenos Aires, C1060AAB, Argentina
Retirado
Research Site, Ciudad de Buenos Aires, C1425AGC, Argentina
Ainda não recrutando
Research Site, Mar del Plata, 7600, Argentina
Ainda não recrutando
Research Site, Rosario, S2000CVD, Argentina
Ainda não recrutando
Research Site, San Nicolás, B2900DMH, Argentina
Ainda não recrutando
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
Ainda não recrutando
Research Site, Yambol, 8600, Bulgaria
Ainda não recrutando

Ontario

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

Quebec

Research Site, Montreal, Quebec, H4J 1C5, Canada
Ainda não recrutando
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, Badalona, 08916, Spain
Retirado
Research Site, Pamplona, 31008, Spain
Retirado
Research Site, Valencia, 46010, Spain
Retirado
Research Site, Kaohsiung City, 80756, Taiwan
Em recrutamento
Research Site, Kaohsiung City, 83301, Taiwan
Em recrutamento
Research Site, New Taipei City, 235, Taiwan
Em recrutamento
Research Site, Taichung, 402, Taiwan
Em recrutamento
Research Site, Taichung, 433004, Taiwan
Em recrutamento
Research Site, Taipei, 10002, Taiwan
Em recrutamento
Research Site, Taipei, 110, Taiwan
Em recrutamento
Research Site, Taoyuan District, 333, Taiwan
Em recrutamento
Research Site, Bangkoknoi, 10700, Thailand
Em recrutamento
Research Site, Changwat Sara Buri, 18000, Thailand
Ainda não recrutando
Research Site, Hat Yai, 90110, Thailand
Em recrutamento
Research Site, Muang, 50200, Thailand
Ainda não recrutando
Research Site, Ratchathewi, 10400, Thailand
Ainda não recrutando
Research Site, Adana, 01060, Turkey (Türkiye)
Ainda não recrutando
Research Site, Adapazarı, 54290, Turkey (Türkiye)
Em recrutamento
Research Site, Kahramanmaraş, 46040, Turkey (Türkiye)
Em recrutamento
Research Site, Kayseri, 38039, Turkey (Türkiye)
Em recrutamento
Research Site, Kocaeli, 41380, Turkey (Türkiye)
Em recrutamento
Research Site, Kyiv, 01601, Ukraine
Em recrutamento
Research Site, Kyiv, 02002, Ukraine
Em recrutamento
Research Site, Kyiv, 02091, Ukraine
Em recrutamento
Research Site, Kyiv, 03037, Ukraine
Em recrutamento
Research Site, Kyiv, 03049, Ukraine
Em recrutamento
Research Site, Kyiv, 04210, Ukraine
Em recrutamento
Research Site, Uzhhorod, 88018, Ukraine
Em recrutamento
Research Site, Vinnytsia, 21029, Ukraine
Em recrutamento
Research Site, Dundee, DD1 9SY, United Kingdom
Ativo, não recrutando
Research Site, Liverpool, L9 7AL, United Kingdom
Em recrutamento
Research Site, London, E1 1FR, United Kingdom
Em recrutamento