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Active, not recruiting Phase 2

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 · tracked via the Priya Life Science UK tracker
Phase
Phase 2
Started
2025-12-05
Last updated
2026-09-01

Condition(s) studied

Chronic Kidney Disease and Hypertension

Investigational drug(s) / intervention(s)

Baxdrostat/dapagliflozin →Baxdrostat/Placebo

Baxdrostat/dapagliflozin: baxdrostat tablet dapagliflozin tablet

Baxdrostat/Placebo: baxdrostat tablet placebo tablet

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria. — Up to 12 weeks
    Change from baseline in UACR

Trial sites (55)

FacilityCityRegionStatus
Research Site Surprise Arizona
Research Site Hollywood Florida
Research Site Port Charlotte Florida
Research Site Port Orange Florida
Research Site East Point Georgia
Research Site Champaign Illinois
Research Site Wichita Kansas
Research Site Greenville North Carolina
Research Site Jacksonville North Carolina
Research Site New Bern North Carolina
Research Site Columbus Ohio
Research Site Media Pennsylvania
Research Site East Providence Rhode Island
Research Site Arlington Texas
Research Site Pasadena Texas
Research Site San Antonio Texas
Research Site Woodbridge Virginia
Research Site Ciudad de Buenos Aires Argentina
Research Site Mar del Plata Argentina
Research Site Rosario Argentina
Research Site San Nicolás Argentina
Research Site Sofia Bulgaria
Research Site Yambol Bulgaria
Research Site Courtice Ontario
Research Site Etobicoke Ontario
Research Site Stouffville Ontario
Research Site Waterloo Ontario
Research Site Kaohsiung City Taiwan
Research Site Kaohsiung City Taiwan
Research Site New Taipei City Taiwan
Research Site Taichung Taiwan
Research Site Taichung Taiwan
Research Site Taipei Taiwan
Research Site Taipei Taiwan
Research Site Taoyuan Taiwan
Research Site Bangkoknoi Thailand
Research Site Changwat Sara Buri Thailand
Research Site Hat Yai Thailand
Research Site Ratchathewi Thailand
Research Site Adana Turkey (Türkiye)

+ 15 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07222917 on ClinicalTrials.gov ↗ ← All trials in the UK