임상 레이더 AI | ||
|---|---|---|
임상시험 NCT07222917 (BaxDuo-Baltic)은(는) Chronic Kidney Disease and Hypertension에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
아스트라제네카A 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) 2상 218 이중 눈가림 국제
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...
더 보기A 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
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Baxdrostat/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 |
위약 대조군Baxdrostat /placebo Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily | Baxdrostat/Placebo baxdrostat tablet
placebo tablet |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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
아스트라제네카Arizona
Florida
Georgia
Illinois
Kansas
New Jersey
North Carolina
Ohio
Pennsylvania
Rhode Island
Texas
Virginia
Ontario
Quebec