Recruiting

BaxDuo-BalticBaxdrostat and Dapagliflozin Effects on Albuminuria in Chronic Kidney Disease with High Blood Pressure

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What is being tested

Baxdrostat/dapagliflozin

+ Baxdrostat/Placebo

Drug
Who is being recruted

Urogenital Diseases+12

+ Cardiovascular Diseases

+ Chronic Disease

Over 18 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 5, 2025

Actual date on which the first participant was enrolled.

This clinical trial focuses on exploring how a combination of two drugs, baxdrostat and dapagliflozin, affects kidney health in adults with chronic kidney disease (CKD) and high blood pressure. The objective is to evaluate whether this combination can improve the condition of the kidneys, specifically by reducing the amount of a protein called albumin in the urine, which is a marker of kidney damage. This study is important because finding more effective treatments could lead to better management of CKD, potentially improving quality of life and health outcomes for those affected. Participants who join the study will be randomly assigned to receive either the combination of baxdrostat and dapagliflozin or baxdrostat with a placebo. The treatment is given orally. Before starting the study, participants undergo a screening to check specific health markers like kidney function and blood pressure. The effectiveness of the treatment is measured by changes in the levels of albumin in urine from the start to the end of the study. This trial is designed to ensure that all participants and researchers do not know which treatment is being given to maintain objectivity. The study also includes monitoring for any potential side effects to ensure safety.

Official TitleA Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.
NCT07222917
Principal SponsorAstraZeneca
Study ContactAstraZeneca Clinical Study Information Center
Last updated: January 28, 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

218 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

7 inclusion criteria required to participate
Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.
Participants with eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.
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12 exclusion criteria prevent from participating
Systolic blood pressure > 180 mmHg, or diastolic blood pressure > 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening
Serum sodium < 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).
Diabetes mellitus: T1DM at the screening visit. Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol)
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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

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily.

Group II

Placebo
Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily

Study Objectives

Primary 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 69 locations

Recruiting

Research Site

Hollywood, United StatesOpen Research Site in Google Maps
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Research Site

Champaign, United States
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Research Site

Eatontown, United States
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Research Site

Courtice, Canada
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69 Study Centers