Baxdrostat + Dapagliflozin for Chronic Kidney Disease and High Blood Pressure

(BaxDuo-Pacific Trial)

Recruiting at 666 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: ACEi, ARB

Disqualifiers: T1DM, Uncontrolled T2DM, Heart failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to 41 months

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, Baxdrostat (an experimental treatment) and Dapagliflozin, to evaluate their effectiveness in helping people with chronic kidney disease and high blood pressure. The researchers aim to determine if this treatment can improve kidney health and reduce the risk of heart-related deaths. Participants are divided into two groups: one receives the actual drugs, while the other receives a placebo (a harmless pill with no active medicine) along with Dapagliflozin. Suitable candidates for this trial include those with long-term kidney problems and persistent high blood pressure, despite taking other blood pressure medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on a stable and maximum tolerated dose of an ACE inhibitor or an ARB for at least 4 weeks before the screening visit.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that baxdrostat, when combined with dapagliflozin, is generally well-tolerated. Earlier studies found that baxdrostat significantly lowered systolic blood pressure and was mostly well-received by participants. Reports from these studies showed no major safety concerns, indicating that side effects were mild or manageable. Clinical trials have already tested this combination in people with chronic kidney disease and high blood pressure, adding to its safety record. Although the trial is still ongoing, previous research supports the safety of this treatment for human use. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for chronic kidney disease and high blood pressure?

Researchers are excited about Baxdrostat in combination with Dapagliflozin for treating chronic kidney disease and high blood pressure because Baxdrostat offers a novel mechanism of action. Unlike most treatments that primarily focus on controlling blood pressure or managing kidney function separately, Baxdrostat targets the enzyme aldosterone synthase, potentially reducing harmful levels of aldosterone that contribute to kidney and heart issues. This dual approach with Dapagliflozin, a well-known SGLT2 inhibitor, could offer enhanced protection for kidney function while effectively managing blood pressure. This combination could lead to better overall outcomes for patients by addressing multiple aspects of these conditions simultaneously.

What evidence suggests that Baxdrostat and Dapagliflozin could be effective for chronic kidney disease and high blood pressure?

In this trial, participants will receive either a combination of Baxdrostat and Dapagliflozin or a placebo with Dapagliflozin. Previous research has shown that Baxdrostat significantly lowers systolic blood pressure, the top number in a blood pressure reading. One study found it reduced blood pressure by 15.7 mmHg, which was 9.8 mmHg more than a placebo. Another study showed it lowered night-time blood pressure by 13.9 mmHg compared to a placebo. Dapagliflozin, a medication often used for kidney and heart health, is already known to help with high blood pressure and kidney problems. Combining these two treatments could improve outcomes for people with chronic kidney disease and high blood pressure. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people with chronic kidney disease and high blood pressure. Participants should not have other serious health conditions that could interfere with the study or be at risk of rapid progression to kidney failure.

Inclusion Criteria

I have a documented history of adrenal insufficiency.

I am not on any new immunosuppression drugs except for stable maintenance ones.

My kidney function is moderately reduced, and I have protein in my urine.

Exclusion Criteria

Known hyperkalaemia defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.

Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.

I have not had dialysis in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants untreated with SGLT2i at screening undergo a 4-week dapagliflozin run-in period

4 weeks

1 visit (in-person)

Treatment

Participants receive either baxdrostat/dapagliflozin or placebo/dapagliflozin in a double-blind manner

Up to 41 months

Visits at 2, 4, 8, 16, 34, and 52 weeks, then every 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Baxdrostat
• Dapagliflozin

Trial Overview The study tests Baxdrostat combined with Dapagliflozin against a placebo/dapagliflozin combo. It's international, multicenter, double-blind (meaning neither doctors nor patients know who gets what), and focuses on how well kidneys work and heart health.

How Is the Trial Designed?

Group I: Baxdrostat/dapagliflozin Experimental Treatment 1 Intervention

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

Group II: Placebo/dapagliflozin Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

In the DAPA-CKD trial, dapagliflozin significantly improved long-term outcomes for patients with chronic kidney disease (CKD), allowing them to spend more time in earlier CKD stages (1-3) and less time in advanced stages (4-5) over a 10-year period.

The use of dapagliflozin is projected to prevent approximately 83 deaths and 51 cases of kidney replacement therapy per 1000 patients, while also reducing the rates of hospitalized heart failure and sudden declines in kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extrapolated longer-term effects of the DAPA-CKD trial: a modelling analysis. McEwan, P., Boyce, R., Sanchez, JJG., et al.[2023]

The fixed-dose combination of dapagliflozin and saxagliptin (QTERN) effectively reduces hemoglobin A1C levels in patients with uncontrolled type 2 diabetes when used alongside metformin, showing a significant difference in A1C reduction compared to other combinations.

QTERN is generally well tolerated, but its use may be limited by cost and modest efficacy in A1C reduction, highlighting the need for further research on its long-term effects on diabetes complications and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin/Saxagliptin Fixed-Dose Tablets: A New Sodium-Glucose Cotransporter 2 and Dipeptidyl Peptidase 4 Combination for the Treatment of Type 2 Diabetes. Coppenrath, VA., Hydery, T.[2022]

Dapagliflozin (DAPA) is an effective SGLT2 inhibitor for treating type 2 diabetes, showing favorable pharmacokinetics and pharmacodynamics that help lower blood sugar levels while having beneficial effects on other metabolic risk factors.

While DAPA is generally safe, it carries an increased risk of genital and urinary infections, and concerns about bladder cancer and cardiovascular safety remain, prompting the FDA to seek further data on these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. Maranghi, M., Carnovale, A., Durante, C., et al.[2021]

Dapagliflozin effectively lowers blood sugar levels and glycated hemoglobin (HbA1c) in patients with type 2 diabetes, with a low risk of hypoglycemia and additional benefits like weight loss and reduced blood pressure.

While it is generally safe, dapagliflozin can increase the risk of genital infections, particularly in women, and its efficacy may be reduced in patients with kidney issues; ongoing trials are investigating its potential cardiovascular and renal protective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. Scheen, AJ.[2021]

Dapagliflozin (Farxiga) is approved for reducing the risk of declining kidney function and kidney failure in adults with chronic kidney disease, regardless of whether they have type 2 diabetes.

It also helps lower the risk of cardiovascular death and hospitalization for heart failure, highlighting its efficacy in managing both kidney and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. Aschenbrenner, DS.[2023]

Citations

1. astrazeneca.com astrazeneca.com/content/astraz/media-centre/press-releases/2025/bax24-phase-iii-trial-full-results.html

Baxdrostat demonstrated a statistically significant and ... Baxdrostat demonstrated a statistically significant placebo-adjusted reduction of 13.9 mmHg in night-time ambulatory systolic blood pressure ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06742723

Study Details | NCT06742723 | A Phase III Renal ... The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo ...

3. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D6972C00002

BaxDuo-Pacific The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and ...

4. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2025/Baxdrostat-demonstrated-statistically-significant-and-clinically-meaningful-reduction-in-systolic-blood-pressure-in-patients-with-hard-to-control-hypertension-in-the-BaxHTN-Phase-III-trial.html

Baxdrostat demonstrated statistically significant and ... Baxdrostat 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted) from baseline, and was generally well tolerated with ...

5. renalandurologynews.com renalandurologynews.com/news/hypertension-baxdrostat-lower-blood-pressure-chronic-kidney-disease-ckd/

Baxdrostat May Lower Systolic BP in CKD With ... A phase 2 trial finds that baxdrostat, an aldosterone synthase inhibitor, meaningfully reduces systolic blood pressure (SBP) in patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06268873

NCT06268873 | A Phase III Study to Investigate the ... 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.