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.
Condition(s) studied
Chronic Kidney Disease and Hypertension
Investigational drug(s) / intervention(s)
Baxdrostat/dapagliflozinBaxdrostat/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
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)
| Facility | City | Region | Status |
| Research Site |
Surprise |
Arizona |
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| Research Site |
Hollywood |
Florida |
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| Research Site |
Port Charlotte |
Florida |
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| Research Site |
Port Orange |
Florida |
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| Research Site |
East Point |
Georgia |
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| Research Site |
Champaign |
Illinois |
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| Research Site |
Wichita |
Kansas |
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| Research Site |
Greenville |
North Carolina |
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| Research Site |
Jacksonville |
North Carolina |
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| Research Site |
New Bern |
North Carolina |
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| Research Site |
Columbus |
Ohio |
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| Research Site |
Media |
Pennsylvania |
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| Research Site |
East Providence |
Rhode Island |
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| Research Site |
Arlington |
Texas |
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| Research Site |
Pasadena |
Texas |
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| Research Site |
San Antonio |
Texas |
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| Research Site |
Woodbridge |
Virginia |
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| Research Site |
Ciudad de Buenos Aires |
Argentina |
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| Research Site |
Mar del Plata |
Argentina |
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| Research Site |
Rosario |
Argentina |
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| Research Site |
San Nicolás |
Argentina |
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| Research Site |
Sofia |
Bulgaria |
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| Research Site |
Yambol |
Bulgaria |
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| Research Site |
Courtice |
Ontario |
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| Research Site |
Etobicoke |
Ontario |
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| Research Site |
Stouffville |
Ontario |
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| Research Site |
Waterloo |
Ontario |
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| Research Site |
Kaohsiung City |
Taiwan |
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| Research Site |
Kaohsiung City |
Taiwan |
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| Research Site |
New Taipei City |
Taiwan |
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| Research Site |
Taichung |
Taiwan |
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| Research Site |
Taichung |
Taiwan |
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| Research Site |
Taipei |
Taiwan |
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| Research Site |
Taipei |
Taiwan |
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| Research Site |
Taoyuan |
Taiwan |
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| Research Site |
Bangkoknoi |
Thailand |
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| Research Site |
Changwat Sara Buri |
Thailand |
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| Research Site |
Hat Yai |
Thailand |
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| Research Site |
Ratchathewi |
Thailand |
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| Research Site |
Adana |
Turkey (Türkiye) |
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+ 15 more sites — see the full list on the official registry below.