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L'essai clinique NCT07222917 (BaxDuo-Baltic) pour Chronic Kidney Disease and Hypertension est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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
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...
Afficher plusA 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.
- BaxDuo-Baltic
- D6972C00006
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
| Groupe de participants/Bras | Intervention/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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria. | Change from baseline in UACR | Up to 12 weeks |
Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
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.
Participants with:
- Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2.
- Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.
Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening
Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).
Diabetes mellitus:
- T1DM at the screening visit
- Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
New York Heart Association functional HF class IV at screening
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
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.
Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.
Documented history of adrenal insufficiency.
Any dialysis (including for acute kidney injury) within 3 months prior to the screening
Any acute kidney injury within 3 months prior to the screening visit.
Prohibited concomitant medications
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