Suspended

Baxdrostat and Dapagliflozin Combination for Chronic Kidney Disease and High Blood Pressure

Study Aim

This phase 3 study aims to evaluate if the combination of Baxdrostat and Dapagliflozin is more effective than Dapagliflozin alone in slowing the progression of chronic kidney disease and high blood pressure, by observing changes in your kidney function over time.

What is being tested

Baxdrostat/dapagliflozin

+ Dapagliflozin in combination with placebo

Drug

Who is being recruted

Urogenital Diseases+12

+ Cardiovascular Diseases

+ Chronic Disease

Over 18 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: March 2024

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: March 29, 2024

Actual date on which the first participant was enrolled.

This clinical trial aims to explore how well and how safely a combination of two drugs, baxdrostat and dapagliflozin, can help people aged 18 and above who have chronic kidney disease (CKD) along with high blood pressure. CKD is a condition where the kidneys do not function properly over a long time, and managing high blood pressure in such patients is crucial to slow down kidney damage. The study seeks to compare whether the combination of these two drugs is more effective at slowing the progression of kidney disease than using dapagliflozin alone. This research is important because finding better treatment options could significantly enhance the quality of life for people living with CKD. Participants in the study start with a screening process followed by a period where they take dapagliflozin alone if they are new to this type of medication. After this, participants are randomly assigned to receive either the combination of baxdrostat and dapagliflozin or just dapagliflozin for 24 months. During this time, regular visits to the study site are scheduled to monitor progress. Following this, all participants switch to taking only dapagliflozin for about six more weeks, during which their kidney function is reassessed. The study involves regular check-ups to ensure safety and effectiveness, and if someone needs to stop the study drugs early, they will continue with dapagliflozin alone unless advised otherwise. This structured approach helps in gathering comprehensive data on how the drugs work together.

Official TitleA Phase III, Randomised, Double-Blind 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

NCT06268873

Principal SponsorAstraZeneca

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

2554 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesCardiovascular DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsHypertensionKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesVascular DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

6 inclusion criteria required to participate

Participants of any sex and gender must be >= 18 years old, or older, at the time of signing the informed consent.

Participants with history of HTN and a SBP >= 130 mmHg at screening and >= 120 mmHg at the randomisation visit

Participants with CKD and eGFR >= 30 and < 90 mL/min/1.73 m2 at screening

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 >= 3.0 and <= 4.8 mmol/L at the Screening Visit for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be >= 3.0 and <= 4.5 mmol/L at the Screening Visit

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12 exclusion criteria prevent from participating

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.

Known hyperkalaemia, defined as potassium of >= 5.5 mmol/L within 3 months at screening.

History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).

New York Heart Association functional HF class IV at screening.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

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.

Group II

Active Comparator

Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily

Study Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 564 locations

Suspended

Research Site

Lanús, ArgentinaOpen Research Site in Google Maps

Suspended

Research Site

Mar del Plata, Argentina

Suspended

Research Site

Mar del Plata, Argentina

Suspended

Research Site

Mendoza, Argentina

Suspended564 Study Centers