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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06268873




Registration number
NCT06268873
Ethics application status
Date submitted
13/02/2024
Date registered
20/02/2024
Date last updated
28/10/2024

Titles & IDs
Public title
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.
Scientific title
A Phase III, Randomised, Double-Blind, Active-controlled Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants With CKD and High Blood Pressure
Secondary ID [1] 0 0
D6972C00003
Universal Trial Number (UTN)
Trial acronym
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 - Dapagliflozin in combination with placebo

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

Active comparator: Dapagliflozin - Patients will receive one dose of dapagliflozin (active comparator) in combination with matching placebo daily


Treatment: Drugs: Baxdrostat/dapagliflozin
baxdrostat tablet

dapagliflozin tablet

Treatment: Drugs: Dapagliflozin in combination with placebo
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 dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.
Timepoint [1] 0 0
Baseline - 2 years + 6 weeks
Secondary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone 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 dapagliflozin alone at reducing SBP.
Timepoint [2] 0 0
Baseline -16 weeks
Secondary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease).
Timepoint [3] 0 0
baseline - 2 years + 6 weeks
Secondary outcome [4] 0 0
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate).
Timepoint [4] 0 0
8 weeks following randomisation to end of treatment

Eligibility
Key inclusion criteria
1. Participants of any sex and gender must be = 18 years old, or older, at the time of signing the informed consent.
2. Participants with CKD and eGFR = 30 and < 90 mL/min/1.73 m2 at screening
3. Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
4. Participants with history of HTN and a SBP = 130 mmHg at screening and = 120 mmHg at the randomisation visit
5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
6. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:

* for participants with screening eGFR = 45 mL/min/1.73 m2, potassium must be = 3.5 and = 4.8 mmol/L at the Screening Visit
* for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be = 3.5 and = 4.5 mmol/L at the Screening Visit
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 DBP > 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 at the Screening Visit, determined as per central laboratory.
4. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) at Screening.
5. New York Heart Association functional HF class IV at screening.
6. 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.
7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
8. Any acute kidney injury within 3 months prior to the Screening Visit
9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
12. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/12/2027
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
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Research Site - Birtinya
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Research Site - Clayton
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Research Site - Gosford
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Research Site - Parkville
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Research Site - Perth
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Research Site - St Leonards
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Research Site - Wollongong
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4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3168 - Clayton
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2250 - Gosford
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2217 - Kogarah
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3050 - Parkville
Recruitment postcode(s) [6] 0 0
6000 - Perth
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2065 - St Leonards
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2500 - Wollongong
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Hochiminh city

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants = 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone.

Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.
Trial website
https://clinicaltrials.gov/study/NCT06268873
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06268873