Dapagliflozin + Baxdrostat for Chronic Kidney Disease

(BaxDuo-Baltic Trial)

Not yet recruiting at 56 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: ACE inhibitors, ARBs

Must not be taking: Mineralocorticoid antagonists, Potassium-sparing diuretics

Disqualifiers: Uncontrolled diabetes, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of medications, baxdrostat and dapagliflozin, to determine if they can reduce protein in urine (albuminuria) and improve safety for people with chronic kidney disease and high blood pressure. Participants will receive either the baxdrostat/dapagliflozin combination or baxdrostat with a placebo. This trial may suit those managing chronic kidney disease and high blood pressure while on a stable dose of certain blood pressure medications. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of either an ACE inhibitor or an ARB for at least 4 weeks before screening. You must also avoid certain medications like mineralocorticoid receptor antagonists and potassium-sparing diuretics for 4 weeks before screening.

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 safe and well-tolerated. Studies examining this combination for safety have not identified any major concerns. One study found that baxdrostat significantly lowered blood pressure in patients with chronic kidney disease, which is promising. Although no major side effects have been reported, it's important to note that the treatment has undergone human testing before, so any serious issues would likely have been discovered. Always consult a healthcare professional for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of dapagliflozin and baxdrostat for chronic kidney disease because it offers a fresh approach compared to standard treatments like ACE inhibitors or ARBs. Unlike these traditional therapies, dapagliflozin is a type of SGLT2 inhibitor that helps kidneys remove excess glucose and sodium, which can reduce kidney stress. Baxdrostat, on the other hand, inhibits aldosterone synthesis, potentially providing added kidney protection by controlling blood pressure and reducing inflammation. This dual-action approach targets multiple pathways, which could enhance kidney function and slow disease progression more effectively than current options.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research shows that using baxdrostat with dapagliflozin may benefit people with chronic kidney disease and high blood pressure. In this trial, one group of participants will receive the combination of baxdrostat and dapagliflozin, while another group will receive baxdrostat with a placebo instead of dapagliflozin. Studies have found that baxdrostat can significantly lower systolic blood pressure by an average of 8.1 mmHg compared to a placebo. Dapagliflozin is already known to help protect the kidneys and control blood sugar levels. Together, these treatments aim to reduce protein in the urine, a sign of kidney damage, and improve kidney function. This combination is being tested because both treatments have shown potential benefits in earlier studies. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults with chronic kidney disease and high blood pressure, having a certain level of kidney function (eGFR ≥ 30 and < 90 mL/min/1.73 m2) and albuminuria can join. They must have stable hypertension, be on specific blood pressure meds for at least 4 weeks, and not have severe liver issues or recent dialysis. Uncontrolled type 2 diabetes patients or those with very high potassium levels are excluded.

Inclusion Criteria

Participants with UACR > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening

Contraceptive use should be consistent with local regulations regarding the methods of contraception for female participants

My kidney function is moderately reduced but not severely.

Exclusion Criteria

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

Timeline for a Trial Participant

Pre-screening

Optional pre-screening period to assess parameters such as eGFR, UACR, potassium, sodium, and BP

2-4 weeks

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Washout

Participants on SGLT2i treatment undergo a washout period before randomization

2 weeks

Treatment

Participants receive either baxdrostat/dapagliflozin or baxdrostat/placebo to evaluate the effect on albuminuria

12 weeks

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 is testing the combination of two drugs: Baxdrostat and Dapagliflozin against Baxdrostat with a placebo to see which is better at reducing protein in urine (albuminuria) in people with kidney disease and hypertension. It's an international trial where neither participants nor doctors know who gets which treatment.

How Is the Trial Designed?

Group I: Baxdrostat/dapagliflozin Experimental Treatment 1 Intervention

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

Group II: Baxdrostat /placebo Placebo Group 1 Intervention

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

Citations

1.

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 ...

2.

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 ...

3.

astrazeneca.com

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

Baxdrostat demonstrated a statistically significant and ...

Significantly more patients treated with baxdrostat (71%) achieved ambulatory 24-hour average SBP of less than 130 mmHg compared with patients ...

4.

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.

5.

renalandurologynews.com

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

Baxdrostat May Lower Systolic BP in CKD With ...

Baxdrostat demonstrated a significant placebo-corrected reduction in systolic BP of -8.1 mmHg (95% confidence interval -13.4 to -2.8 mm Hg, P= ...