RecruitingPhase 3

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well baxdrostat taken with dapagliflozin works and how safe it is. It is for adults with long-term kidney disease and high blood pressure, and looks at kidney health and deaths from heart or blood vessel problems.

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • Meet one of two kidney test patterns below. eGFR measures how well your kidneys filter blood. UACR and UPCR measure protein in urine.
  • Have an eGFR of 30–59, plus a UACR of 30–5000 mg/g or a UPCR of 700–7000 mg/g. A UACR below 500 must come from the study’s central lab; UPCR must come from a local lab.
  • Or have an eGFR of 60–75, plus a UACR of 500–5000 mg/g or a UPCR of 700–7000 mg/g. UPCR must come from a local lab.
  • Have a history of high blood pressure. The top number must be at least 130 at screening or within the 4 weeks before it, and at least 120 when assigned to a study group.
  • Take a steady dose of an ACE inhibitor or ARB—not both—for at least 4 weeks before screening. These are blood pressure medicines, and the dose must be the highest you can tolerate.
  • Have blood potassium of 3.0–4.8 mmol/L if your eGFR is 45 or higher, or 3.0–4.5 mmol/L if your eGFR is below 45.

Who can't join

  • Blood pressure above 180 for the top number or above 110 for the bottom number at screening.
  • Blood potassium of 5.5 mmol/L or higher within the past 3 months, or blood sodium below 135 mmol/L at screening or within the 4 weeks before it.
  • Type 1 diabetes, with limited exceptions: in the US, you must have taken an SGLT2 inhibitor for at least 4 months, had no diabetic ketoacidosis during that time, and have experience checking ketones. In Japan, you must have taken dapagliflozin 10 mg for at least 4 months with no diabetic ketoacidosis during treatment. Ketoacidosis is a dangerous buildup of acids in the blood.
  • Type 2 diabetes that is not controlled, with HbA1c above 10.5% at screening or within the past 3 months. HbA1c measures average blood sugar.
  • The most severe level of heart failure, called class IV, at screening; or a stroke, mini-stroke, heart valve procedure, neck artery procedure, sudden serious heart blood-flow problem, or hospital stay for worsening heart failure within 3 months before study group assignment.
  • A history of adrenal glands not making enough hormones; or any sudden kidney injury or dialysis within 3 months before screening. Dialysis is a treatment that filters the blood.
  • A past organ or bone marrow transplant, or a planned organ transplant within 6 months after study group assignment.
  • A condition needing medicine that lowers immune activity throughout the body, unless it is ongoing treatment that has been steady for at least 3 months before the first visit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND: * UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or * UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or * UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only). (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND: * UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or * UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only) 3. \[obsolete\] 4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit. 5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit. 6. Participants with: 1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values) 2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2 (local or central laboratory values) Exclusion Criteria: 1. Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screening. 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening. 3. Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit). 4\. Participants with T1DM will be excluded, except: 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion. 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion. 5 Uncontrolled T2DM with HbA1c \> 10.5% (\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit). 6 New York Heart Association functional HF class IV at screening. 7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation. 8 Documented history of adrenal insufficiency. 9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit. 10 Any acute kidney injury within 3 months prior to the Screening Visit. 11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant). 12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).

Study sites (133)

AL

AZ

CA

CO

CT

DC

FL

GA

HI

IA

ID

IL

IN

KS

LA

MA

MD

MI

MO

NC

NE

NJ

NV

NY

OH

OR

PA

RI

SC

TN

TX

UT

VA

VT

WA