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Compares treatment options for Chronic Kidney Disease and Hypertension
Official title 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.
ClinicalTrials.gov ID: NCT07222917
What this study is testing
What is Baxdrostat/dapagliflozin?
Baxdrostat/dapagliflozin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney disease and hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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
+ 40 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 54 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.