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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) Phase II 218 Double aveugle International

En recrutement
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L'essai clinique NCT07222917 (BaxDuo-Baltic) est conçu pour étudier le traitement de Chronic Kidney Disease and Hypertension. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : en recrutement. L'étude a débuté le 5 décembre 2025 et vise à recruter 218 participants. Dirigée par AstraZeneca, l'étude devrait être terminée d'ici le 24 mai 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 3 avril 2026.
Résumé succinct
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.
Description détaillée
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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Titre officiel

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.

Pathologies
Chronic Kidney Disease and Hypertension
Autres identifiants de l'étude
  • BaxDuo-Baltic
  • D6972C00006
Numéro NCT
Date de début (réel)
2025-12-05
Dernière mise à jour publiée
2026-04-03
Date de fin (estimée)
2027-05-24
Inscription (estimée)
218
Type d'étude
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
Chronic kidney disease
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
Objectif principal
Traitement
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Quadruple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalBaxdrostat/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
Comparateur placeboBaxdrostat /placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily
Baxdrostat/Placebo
baxdrostat tablet placebo tablet
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.
Change from baseline in UACR
Up to 12 weeks
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  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
Contact central de l'étude
Contact: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
71 Centres de l'étude dans 11 pays

Ontario

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

Quebec

Research Site, Montreal, Quebec, H4J 1C5, Canada
Pas encore en recrutement

Arizona

Research Site, Surprise, Arizona, 85374, United States
En recrutement

Florida

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

Georgia

Research Site, Atlanta, Georgia, 30344, United States
En recrutement

Illinois

Research Site, Champaign, Illinois, 61822, United States
En recrutement

Kansas

Research Site, Wichita, Kansas, 67214, United States
En recrutement

New Jersey

Research Site, Eatontown, New Jersey, 07724, United States
En recrutement

North Carolina

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

Ohio

Research Site, Columbus, Ohio, 43215, United States
En recrutement

Pennsylvania

Research Site, Media, Pennsylvania, 19063, United States
En recrutement

Rhode Island

Research Site, East Providence, Rhode Island, 02914, United States
En recrutement

Texas

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

Virginia

Research Site, Woodbridge, Virginia, 22192, United States
En recrutement
Research Site, Buenos Aires, C1060AAB, Argentina
Retiré
Research Site, Ciudad de Buenos Aires, C1425AGC, Argentina
Pas encore en recrutement
Research Site, Mar del Plata, 7600, Argentina
Pas encore en recrutement
Research Site, Rosario, S2000CVD, Argentina
Pas encore en recrutement
Research Site, San Nicolás, B2900DMH, Argentina
Pas encore en recrutement
Research Site, Pernik, 2300, Bulgaria
Retiré
Research Site, Plovdiv, 4004, Bulgaria
Retiré
Research Site, Sofia, 1431, Bulgaria
Retiré
Research Site, Sofia, 1680, Bulgaria
Retiré
Research Site, Sofia, 1756, Bulgaria
Retiré
Research Site, Sofia, 1756, Bulgaria
Pas encore en recrutement
Research Site, Yambol, 8600, Bulgaria
Pas encore en recrutement
Research Site, Anyang-si, 14068, South Korea
Retiré
Research Site, Cheonan-si, 31151, South Korea
Retiré
Research Site, Goyang-si, 10380, South Korea
Retiré
Research Site, Seoul, 04401, South Korea
Retiré
Research Site, Badalona, 08916, Spain
Retiré
Research Site, Pamplona, 31008, Spain
Retiré
Research Site, Valencia, 46010, Spain
Retiré
Research Site, Kaohsiung City, 80756, Taiwan
En recrutement
Research Site, Kaohsiung City, 83301, Taiwan
En recrutement
Research Site, New Taipei City, 235, Taiwan
En recrutement
Research Site, Taichung, 402, Taiwan
En recrutement
Research Site, Taichung, 433004, Taiwan
En recrutement
Research Site, Taipei, 10002, Taiwan
En recrutement
Research Site, Taipei, 110, Taiwan
En recrutement
Research Site, Taoyuan District, 333, Taiwan
En recrutement
Research Site, Bangkoknoi, 10700, Thailand
En recrutement
Research Site, Changwat Sara Buri, 18000, Thailand
Pas encore en recrutement
Research Site, Hat Yai, 90110, Thailand
En recrutement
Research Site, Muang, 50200, Thailand
Pas encore en recrutement
Research Site, Ratchathewi, 10400, Thailand
Pas encore en recrutement
Research Site, Adana, 01060, Turkey (Türkiye)
Pas encore en recrutement
Research Site, Adapazarı, 54290, Turkey (Türkiye)
En recrutement
Research Site, Kahramanmaraş, 46040, Turkey (Türkiye)
En recrutement
Research Site, Kayseri, 38039, Turkey (Türkiye)
En recrutement
Research Site, Kocaeli, 41380, Turkey (Türkiye)
En recrutement
Research Site, Kyiv, 01601, Ukraine
En recrutement
Research Site, Kyiv, 02002, Ukraine
En recrutement
Research Site, Kyiv, 02091, Ukraine
En recrutement
Research Site, Kyiv, 03037, Ukraine
En recrutement
Research Site, Kyiv, 03049, Ukraine
En recrutement
Research Site, Kyiv, 04210, Ukraine
En recrutement
Research Site, Uzhhorod, 88018, Ukraine
En recrutement
Research Site, Vinnytsia, 21029, Ukraine
En recrutement
Research Site, Dundee, DD1 9SY, United Kingdom
Actif, ne recrute pas
Research Site, Liverpool, L9 7AL, United Kingdom
En recrutement
Research Site, London, E1 1FR, United Kingdom
En recrutement