治験レーダーAI | ||
|---|---|---|
治験 NCT07222917 (BaxDuo-Baltic)（対象：Chronic Kidney Disease and Hypertension）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
アストラゼネカ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) 第II相・フェーズ2 218 二重盲検 国際共同
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...
もっと見る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.
- BaxDuo-Baltic
- D6972C00006
Hypertension
Blood pressure
Baxdrostat
Dapagliflozin
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Baxdrostat/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 |
プラセボ対照薬Baxdrostat /placebo Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily | Baxdrostat/Placebo baxdrostat tablet
placebo tablet |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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
アストラゼネカArizona
Florida
Georgia
Illinois
Kansas
New Jersey
North Carolina
Ohio
Pennsylvania
Rhode Island
Texas
Virginia
Ontario
Quebec