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Baxdrostat + Dapagliflozin for Chronic Kidney Disease

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
Must not have
Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% at Screening
New York Heart Association functional HF class IV at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 2 years + 6 weeks
Awards & highlights

Summary

This trial is testing the effectiveness and safety of a drug called baxdrostat/dapagliflozin in adults over 18 with chronic kidney disease (CKD) and high blood pressure

Who is the study for?
This trial is for adults with chronic kidney disease (CKD) and high blood pressure. Participants should not have previously used SGLT2 inhibitors, a type of diabetes medication. They must be willing to take the study drugs and visit the site regularly over two years.Check my eligibility
What is being tested?
The trial tests if baxdrostat combined with dapagliflozin can slow down CKD progression better than dapagliflozin alone in patients with CKD and hypertension. It's a double-blind study, meaning neither participants nor researchers know who gets which treatment until after the results are collected.See study design
What are the potential side effects?
Possible side effects include those common to SGLT2 inhibitors like dehydration, low blood sugar, yeast infections, urinary tract infections, changes in urination, and low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is reduced but not severely (eGFR between 30 and 90).
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I have high blood pressure with readings of at least 130 mmHg during screening and 120 mmHg when joining the study.
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I am 18 years or older and can give informed consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Type 1 diabetes or my Type 2 diabetes is not under control with an HbA1c over 10.5%.
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My heart failure is severe, limiting my physical activity significantly.
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I have had or will have an organ or bone marrow transplant.
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I have been on stable immunosuppression therapy for over 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 2 years + 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 2 years + 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.
Secondary outcome measures
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease).
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).
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP.
+1 more

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Baxdrostat/dapagliflozinExperimental Treatment1 Intervention
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: DapagliflozinActive Control1 Intervention
Patients will receive one dose of dapagliflozin (active comparator) in combination with matching placebo daily

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,302 Previous Clinical Trials
288,622,099 Total Patients Enrolled
4 Trials studying Kidney Failure
7,810 Patients Enrolled for Kidney Failure
~1667 spots leftby Dec 2027