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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 2 218 Dubbelblind Internationaal

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De klinische studie NCT07222917 (BaxDuo-Baltic) onderzoekt behandeling bij Chronic Kidney Disease and Hypertension. Deze Fase 2 interventioneel-studie heeft de status rekruterend. Het doel is om 218 deelnemers te includeren vanaf 5 december 2025. De studie wordt geleid door AstraZeneca en de voltooiing is gepland op 24 mei 2027. Laatste update op ClinicalTrials.gov: 3 april 2026.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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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Officiële titel

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.

Aandoeningen
Chronic Kidney Disease and Hypertension
Andere studie-ID's
  • BaxDuo-Baltic
  • D6972C00006
NCT-ID
Startdatum (Werkelijk)
2025-12-05
Laatste update geplaatst
2026-04-03
Verwachte einddatum
2027-05-24
Inschrijving (Geschat)
218
Studietype
Interventioneel
FASE
Fase 2
Status
Rekruterend
Trefwoorden
Chronic kidney disease
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelBaxdrostat/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
Placebo-comparatorBaxdrostat /placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily
Baxdrostat/Placebo
baxdrostat tablet placebo tablet
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
Up to 12 weeks
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  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
Centraal Contactpersoon
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
71 Studielocaties in 11 landen

Arizona

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

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

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

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

Research Site, Wichita, Kansas, 67214, United States
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New Jersey

Research Site, Eatontown, New Jersey, 07724, United States
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North Carolina

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

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

Research Site, Media, Pennsylvania, 19063, United States
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Rhode Island

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

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

Research Site, Woodbridge, Virginia, 22192, United States
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Research Site, Buenos Aires, C1060AAB, Argentina
Ingetrokken
Research Site, Ciudad de Buenos Aires, C1425AGC, Argentina
Nog niet rekruterend
Research Site, Mar del Plata, 7600, Argentina
Nog niet rekruterend
Research Site, Rosario, S2000CVD, Argentina
Nog niet rekruterend
Research Site, San Nicolás, B2900DMH, Argentina
Nog niet rekruterend
Research Site, Pernik, 2300, Bulgaria
Ingetrokken
Research Site, Plovdiv, 4004, Bulgaria
Ingetrokken
Research Site, Sofia, 1431, Bulgaria
Ingetrokken
Research Site, Sofia, 1680, Bulgaria
Ingetrokken
Research Site, Sofia, 1756, Bulgaria
Ingetrokken
Research Site, Sofia, 1756, Bulgaria
Nog niet rekruterend
Research Site, Yambol, 8600, Bulgaria
Nog niet rekruterend

Ontario

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

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