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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.
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
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