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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.
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.

NCT07222917

RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Chronic Kidney Disease and Hypertension

Interventions: Baxdrostat/dapagliflozin, Baxdrostat/Placebo

Countries: United States, Argentina, Bulgaria, Canada, South Korea, Spain, Taiwan, Thailand

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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.

Exclusion Criteria:

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
Locations (71)
  • Surprise, Arizona, United States
  • Hollywood, Florida, United States
  • Port Charlotte, Florida, United States
  • Port Orange, Florida, United States
  • Atlanta, Georgia, United States
  • Champaign, Illinois, United States
  • Wichita, Kansas, United States
  • Eatontown, New Jersey, United States
  • Greenville, North Carolina, United States
  • Jacksonville, North Carolina, United States
  • New Bern, North Carolina, United States
  • Columbus, Ohio, United States
  • Media, Pennsylvania, United States
  • East Providence, Rhode Island, United States
  • Arlington, Texas, United States
  • Pasadena, Texas, United States
  • San Antonio, Texas, United States
  • Woodbridge, Virginia, United States
  • Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Mar del Plata, Argentina
  • Rosario, Argentina
  • San Nicolás, Argentina
  • Pernik, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Yambol, Bulgaria
  • + 41 more on CT.gov