BridgeMD
A Phase IIb study to evaluate the effect of combination of dapagliflozin and baxdrostat compared with baxdrostat alone in participants with chronic kidney disease and high blood pressure
EU CTIS ID: 2025-522407-23-00
What this study is testing
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/placebo at reducing albuminuria
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 medically contraindicated.
- Participants with: (a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2. (b) Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2.
You likely can't join if
- Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.
- 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
- Known hyperkalaemia, defined as potassium of ≥ 5.5mmol/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).
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: (a) Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2. (b) 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.
- 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
- Known hyperkalaemia, defined as potassium of ≥ 5.5mmol/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: (a) T1DM at the screening visit (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91mmol/mol)
- New York Heart Association functional HF class IV at screening
- Any use of mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders 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.
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Taiwan
- Canada
- United States
- United Kingdom
- Argentina
- Ukraine
- Turkey
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Taiwan; Canada; United States; United Kingdom; Argentina and 2 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 EU CTIS; the study team decides eligibility.