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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 Doppio cieco Internazionale

In arruolamento
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La sperimentazione clinica NCT07222917 (BaxDuo-Baltic) è uno studio interventistico di Fase II volto a esaminare il trattamento per Chronic Kidney Disease and Hypertension, attualmente in arruolamento. Avviato il 5 dicembre 2025, prevede di arruolare 218 partecipanti. Sotto la guida di AstraZeneca, dovrebbe concludersi entro il 24 maggio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 3 aprile 2026.
Sommario breve
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.
Descrizione dettagliata
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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Titolo ufficiale

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.

Patologie
Chronic Kidney Disease and Hypertension
Altri ID dello studio
  • BaxDuo-Baltic
  • D6972C00006
Numero NCT
Data di inizio (effettiva)
2025-12-05
Ultimo aggiornamento pubblicato
2026-04-03
Data di completamento (stimata)
2027-05-24
Arruolamento (previsto)
218
Tipo di studio
Interventistico
FASE
Fase II
Stato
In arruolamento
Parole chiave
Chronic kidney disease
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Quadruplo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleBaxdrostat/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
Comparatore placeboBaxdrostat /placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily
Baxdrostat/Placebo
baxdrostat tablet placebo tablet
Esito primario
Misure di esitoDescrizione della misuraArco temporale
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
Up to 12 weeks
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  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
Contatti principali dello studio
Contatto: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
71 Centri dello studio in 11 paesi

Arizona

Research Site, Surprise, Arizona, 85374, United States
In arruolamento

Florida

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

Georgia

Research Site, Atlanta, Georgia, 30344, United States
In arruolamento

Illinois

Research Site, Champaign, Illinois, 61822, United States
In arruolamento

Kansas

Research Site, Wichita, Kansas, 67214, United States
In arruolamento

New Jersey

Research Site, Eatontown, New Jersey, 07724, United States
In arruolamento

North Carolina

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

Ohio

Research Site, Columbus, Ohio, 43215, United States
In arruolamento

Pennsylvania

Research Site, Media, Pennsylvania, 19063, United States
In arruolamento

Rhode Island

Research Site, East Providence, Rhode Island, 02914, United States
In arruolamento

Texas

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

Virginia

Research Site, Woodbridge, Virginia, 22192, United States
In arruolamento
Research Site, Buenos Aires, C1060AAB, Argentina
Ritirato
Research Site, Ciudad de Buenos Aires, C1425AGC, Argentina
Non ancora in arruolamento
Research Site, Mar del Plata, 7600, Argentina
Non ancora in arruolamento
Research Site, Rosario, S2000CVD, Argentina
Non ancora in arruolamento
Research Site, San Nicolás, B2900DMH, Argentina
Non ancora in arruolamento
Research Site, Pernik, 2300, Bulgaria
Ritirato
Research Site, Plovdiv, 4004, Bulgaria
Ritirato
Research Site, Sofia, 1431, Bulgaria
Ritirato
Research Site, Sofia, 1680, Bulgaria
Ritirato
Research Site, Sofia, 1756, Bulgaria
Ritirato
Research Site, Sofia, 1756, Bulgaria
Non ancora in arruolamento
Research Site, Yambol, 8600, Bulgaria
Non ancora in arruolamento

Ontario

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

Quebec

Research Site, Montreal, Quebec, H4J 1C5, Canada
Non ancora in arruolamento
Research Site, Anyang-si, 14068, South Korea
Ritirato
Research Site, Cheonan-si, 31151, South Korea
Ritirato
Research Site, Goyang-si, 10380, South Korea
Ritirato
Research Site, Seoul, 04401, South Korea
Ritirato
Research Site, Badalona, 08916, Spain
Ritirato
Research Site, Pamplona, 31008, Spain
Ritirato
Research Site, Valencia, 46010, Spain
Ritirato
Research Site, Kaohsiung City, 80756, Taiwan
In arruolamento
Research Site, Kaohsiung City, 83301, Taiwan
In arruolamento
Research Site, New Taipei City, 235, Taiwan
In arruolamento
Research Site, Taichung, 402, Taiwan
In arruolamento
Research Site, Taichung, 433004, Taiwan
In arruolamento
Research Site, Taipei, 10002, Taiwan
In arruolamento
Research Site, Taipei, 110, Taiwan
In arruolamento
Research Site, Taoyuan District, 333, Taiwan
In arruolamento
Research Site, Bangkoknoi, 10700, Thailand
In arruolamento
Research Site, Changwat Sara Buri, 18000, Thailand
Non ancora in arruolamento
Research Site, Hat Yai, 90110, Thailand
In arruolamento
Research Site, Muang, 50200, Thailand
Non ancora in arruolamento
Research Site, Ratchathewi, 10400, Thailand
Non ancora in arruolamento
Research Site, Adana, 01060, Turkey (Türkiye)
Non ancora in arruolamento
Research Site, Adapazarı, 54290, Turkey (Türkiye)
In arruolamento
Research Site, Kahramanmaraş, 46040, Turkey (Türkiye)
In arruolamento
Research Site, Kayseri, 38039, Turkey (Türkiye)
In arruolamento
Research Site, Kocaeli, 41380, Turkey (Türkiye)
In arruolamento
Research Site, Kyiv, 01601, Ukraine
In arruolamento
Research Site, Kyiv, 02002, Ukraine
In arruolamento
Research Site, Kyiv, 02091, Ukraine
In arruolamento
Research Site, Kyiv, 03037, Ukraine
In arruolamento
Research Site, Kyiv, 03049, Ukraine
In arruolamento
Research Site, Kyiv, 04210, Ukraine
In arruolamento
Research Site, Uzhhorod, 88018, Ukraine
In arruolamento
Research Site, Vinnytsia, 21029, Ukraine
In arruolamento
Research Site, Dundee, DD1 9SY, United Kingdom
Attivo, non in arruolamento
Research Site, Liverpool, L9 7AL, United Kingdom
In arruolamento
Research Site, London, E1 1FR, United Kingdom
In arruolamento