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
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
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 (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).
Primary outcome measure(s)
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. — Up to 37 months Time to the first occurrence of any of the components of the composite of:
Kidney disease progression
* ≥ 50% sustained decline in eGFR
* Onset of kidney failure:
* Sustained eGFR \< 15 mL/min/1.73 m2 or
* Chronic dialysis treatment or
* Receiving a kidney transplant or
* Death with a renal primary cause (death due to kidney failure when dialysis is not given)
CV events
* HF with or without hospitalisation
* CV death
Trial sites (771)
Facility
City
Region
Status
Research Site
Fairhope
Alabama
Recruiting
Research Site
Surprise
Arizona
Recruiting
Research Site
Tucson
Arizona
Recruiting
Research Site
Beverly Hills
California
Recruiting
Research Site
Canoga Park
California
Withdrawn
Research Site
Concord
California
Recruiting
Research Site
Fremont
California
Recruiting
Research Site
Fullerton
California
Recruiting
Research Site
Inglewood
California
Withdrawn
Research Site
Los Alamitos
California
Recruiting
Research Site
Los Angeles
California
Recruiting
Research Site
San Diego
California
Withdrawn
Research Site
San Francisco
California
Withdrawn
Research Site
Stanford
California
Recruiting
Research Site
Tarzana
California
Recruiting
Research Site
Arvada
Colorado
Recruiting
Research Site
Denver
Colorado
Withdrawn
Research Site
New Britain
Connecticut
Recruiting
Research Site
Washington D.C.
District of Columbia
Recruiting
Research Site
Boca Raton
Florida
Recruiting
Research Site
Boynton Beach
Florida
Recruiting
Research Site
Edgewater
Florida
Recruiting
Research Site
Fort Lauderdale
Florida
Recruiting
Research Site
Hollywood
Florida
Recruiting
Research Site
Jacksonville Beach
Florida
Recruiting
Research Site
Lake City
Florida
Recruiting
Research Site
Lakeland
Florida
Recruiting
Research Site
Melbourne
Florida
Recruiting
Research Site
Miami Lakes
Florida
Suspended
Research Site
Ocoee
Florida
Recruiting
Research Site
Port Charlotte
Florida
Recruiting
Research Site
Port Orange
Florida
Recruiting
Research Site
Riverview
Florida
Recruiting
Research Site
Atlanta
Georgia
Recruiting
Research Site
Augusta
Georgia
Withdrawn
Research Site
Austell
Georgia
Recruiting
Research Site
Brunswick
Georgia
Recruiting
Research Site
Conyers
Georgia
Recruiting
Research Site
Decatur
Georgia
Recruiting
Research Site
East Point
Georgia
Recruiting
+ 731 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.
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