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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

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 2 years + 6 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

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Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 7Eligibility criteria met