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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06742723




Registration number
NCT06742723
Ethics application status
Date submitted
16/12/2024
Date registered
19/12/2024

Titles & IDs
Public 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
Scientific title
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
Secondary ID [1] 0 0
2023-506460-14-00
Secondary ID [2] 0 0
D6972C00002
Universal Trial Number (UTN)
Trial acronym
BaxDuo-Pacific
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease and Hypertension 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baxdrostat/dapagliflozin
Treatment: Drugs - Placebo/dapagliflozin

Experimental: Baxdrostat/dapagliflozin - Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

Placebo comparator: Placebo/dapagliflozin - Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.


Treatment: Drugs: Baxdrostat/dapagliflozin
baxdrostat tablet

dapagliflozin tablet

Treatment: Drugs: Placebo/dapagliflozin
dapagliflozin tablet

placebo tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of = 50% sustained decline in eGFR (estimated glomerular filtration rate)
Timepoint [1] 0 0
Up to 41 months
Primary outcome [2] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of kidney failure
Timepoint [2] 0 0
Up to 41 months
Primary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death.
Timepoint [3] 0 0
Up to 41 months
Secondary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin at reducing UACR (urine albumin-creatinine ratio).
Timepoint [1] 0 0
Baseline- 16 weeks
Secondary outcome [2] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin at reducing SBP (systolic blood pressure).
Timepoint [2] 0 0
Baseline- 16 weeks
Secondary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events).
Timepoint [3] 0 0
Up to 41 months
Secondary outcome [4] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death.
Timepoint [4] 0 0
Up to 41 months
Secondary outcome [5] 0 0
To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause death.
Timepoint [5] 0 0
Up to 41 months

Eligibility
Key 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:

1. eGFR = 30 and < 60 mL/min/1.73 m2 (local or central laboratory values) AND UACR = 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory values only), or
2. eGFR = 30 and = 75 mL/min/1.73 m2 (local or central laboratory values) AND UACR = 500 mg/g (56.5 mg/mmol) and = 5000 mg/g (565 mg/mmol) or UPCR = 700 mg/g (79 mg/mmol) and = 7000 mg/g (790 mg/mmol) (local or central laboratory values).
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).
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 prior to 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. T1DM:

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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/04/2030
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Gosford
Recruitment hospital [2] 0 0
Research Site - Perth
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Research Site - st Leonards
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Research Site - Wollongong
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2250 - Gosford
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment postcode(s) [3] 0 0
2065 - st Leonards
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06742723