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.

Recruiting · NCT07222917 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

Baxdrostat/PlaceboBaxdrostat/dapagliflozin

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

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

Where it is running

60 locations listed across 12 US states.

Research Site - Surprise, Arizona, United States
Research Site - Hollywood, Florida, United States
Research Site - Port Charlotte, Florida, United States
Research Site - Port Orange, Florida, United States
Research Site - Atlanta, Georgia, United States
Research Site - Champaign, Illinois, United States
Research Site - Wichita, Kansas, United States
Research Site - Eatontown, New Jersey, United States
Research Site - Greenville, North Carolina, United States
Research Site - Jacksonville, North Carolina, United States
Research Site - New Bern, North Carolina, United States
Research Site - Columbus, Ohio, United States
Research Site - Media, Pennsylvania, United States
Research Site - East Providence, Rhode Island, United States
Research Site - Arlington, Texas, United States
Research Site - Pasadena, Texas, United States
Research Site - San Antonio, Texas, United States
Research Site - Woodbridge, Virginia, United States
Research Site - Adana, Turkey (Türkiye)
Research Site - Adapazarı, Turkey (Türkiye)
Research Site - Anyang-si, South Korea
Research Site - Badalona, Spain
Research Site - Bangkoknoi, Thailand
Research Site - Buenos Aires, Argentina
Research Site - Changwat Sara Buri, Thailand
Research Site - Cheonan-si, South Korea
Research Site - Ciudad de Buenos Aires, Argentina
Research Site - Dundee, United Kingdom
Research Site - Goyang-si, South Korea
Research Site - Hat Yai, Thailand
Research Site - Kahramanmaraş, Turkey (Türkiye)
Research Site - Kaohsiung City, Taiwan
Research Site - Kaohsiung City, Taiwan
Research Site - Kayseri, Turkey (Türkiye)
Research Site - Kocaeli, Turkey (Türkiye)
Research Site - Kyiv, Ukraine
Research Site - Kyiv, Ukraine
Research Site - Kyiv, Ukraine
Research Site - Kyiv, Ukraine
Research Site - Kyiv, Ukraine
Research Site - Kyiv, Ukraine
Research Site - Liverpool, United Kingdom
Research Site - London, United Kingdom
Research Site - Mar del Plata, Argentina
Research Site - Muang, Thailand
Research Site - New Taipei City, Taiwan
Research Site - Pamplona, Spain
Research Site - Pernik, Bulgaria
Research Site - Plovdiv, Bulgaria
Research Site - Ratchathewi, Thailand
Research Site - Rosario, Argentina
Research Site - San Nicolás, Argentina
Research Site - Seoul, South Korea
Research Site - Sofia, Bulgaria
Research Site - Sofia, Bulgaria
Research Site - Sofia, Bulgaria
Research Site - Sofia, Bulgaria
Research Site - Taichung, Taiwan
Research Site - Taichung, Taiwan
Research Site - Taipei, Taiwan

Showing 60 of 71 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →