Testing Baxdrostat/dapagliflozin against a placebo for chronic kidney disease and hypertension
Official title: 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
Interventions
Baxdrostat/dapagliflozin
baxdrostat tablet dapagliflozin tablet
Placebo/dapagliflozin
dapagliflozin tablet placebo tablet
Canadian Sites (21)
Research Site
Edmonton, Alberta, Canada
Research Site
Surrey, British Columbia, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Saint John, New Brunswick, Canada
Research Site
Halifax, Nova Scotia, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Oshawa, Ontario, Canada
Research Site
Sarnia, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Waterloo, Ontario, Canada
Research Site
Laval, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Eligibility Criteria
See who this study is looking for29 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:
- +(b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:
- +Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)
- +Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Participants with (a) or (b):
- +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).
- +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)
- +\[obsolete\]
- +Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or at the Screening Visit) and ≥ 120 mmHg at the RandomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → Visit.
- +Stable and maximum tolerated doseMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more → of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.
- +Participants with:
- +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
- −Systolic blood pressure \> 180 mmHg, or diastolic BP \> 110 mmHg at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- −Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
- −Serum sodium \< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).
- −\. Participants with T1DM will be excluded, except:
- −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 inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →.
- −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.
- −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).
- −New York Heart Association functional HF class IV at screening.
- −Documented history of adrenal insufficiency.
- −Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
- −Any acute kidney injury within 3 months prior to the Screening Visit.
- −History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (including kidney transplant).
- −Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Baxdrostat/dapagliflozin, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →/dapagliflozin.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 5,000 people.
The study is currently expected to finish around December 2029.
The main measurement is taken over: Up to 37 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
To determine whether baxdrostat/dapagliflozin is superior to placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →/dapagliflozin in reducing the risk of the composite endpointEndpointThe specific thing a study measures to answer its question.Read more → of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death — measured over Up to 37 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06742723 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Baxdrostat/dapagliflozinDrug
baxdrostat tablet dapagliflozin tablet
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo/dapagliflozinDrug
dapagliflozin tablet placebo tablet
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 37 months.
The study as a whole is currently expected to finish around 2029-12-18.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 5,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 23 locations, including: Edmonton, Alberta, Canada; Surrey, British Columbia, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Saint John, New Brunswick, Canada; Halifax, Nova Scotia, Canada, and 17 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
Other Sites (8)
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
Research Site
Garden City, Michigan, United States
Research Site
Saint Joseph, Michigan, United States
Research Site
Albany, New York, United States
Research Site
Buffalo, New York, United States
Research Site
New York, New York, United States
Research Site
Seattle, Washington, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.