What is baxdrostat studying for chronic kidney disease and high blood pressure?

Baxdrostat is being studied in combination with dapagliflozin to see how it affects albuminuria, a marker of kidney function, in people with chronic kidney disease and high blood pressure. This research aims to understand the safety and impact of these treatments under the sponsor AstraZeneca. Participants will help determine if this combination works better than baxdrostat alone.

Who may be eligible for this chronic kidney disease clinical trial?

Adults aged 18 and older with chronic kidney disease and high blood pressure may be eligible. Participants can have type 2 diabetes or not, and need to have certain kidney function levels and blood pressure readings. People with uncontrolled diabetes or very high blood pressure may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic kidney disease clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07222917

Phase IIb Study of Baxdrostat Combined With Dapagliflozin Versus Baxdrostat Alone to Reduce Albuminuria in Adults With Chronic Kidney Disease and High Blood Pressure

Led by AstraZeneca · Updated on 2026-05-18

218

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease CKD and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio UACR to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.

CONDITIONS

Brief Title

A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants of any sex and gender must be 18 years or older at the time of signing consent
eGFR between 30 and 90 mL/min/1.73 m2 at screening
Urine albumin-to-creatinine ratio (UACR) greater than 200 mg/g and less than 5000 mg/g at screening
History of hypertension with systolic blood pressure 130 mmHg or higher at screening and 120 mmHg or higher at randomisation
Stable and maximum tolerated daily dose of either an ACE inhibitor or an ARB for at least 4 weeks prior to screening, if not medically contraindicated
Serum or plasma potassium between 3.0 and 4.8 mmol/L if eGFR is 45 mL/min/1.73 m2 or higher
Serum or plasma potassium between 3.0 and 4.5 mmol/L if eGFR is less than 45 mL/min/1.73 m2
Female participants must use contraception consistent with local regulations during the study

You will not qualify if you...

Systolic blood pressure higher than 180 mmHg or diastolic blood pressure higher than 110 mmHg at screening
Known hyperkalaemia with potassium 5.5 mmol/L or higher within 3 months before screening
Serum sodium less than 135 mmol/L at screening
Type 1 diabetes mellitus at screening
Uncontrolled type 2 diabetes with HbA1C greater than 10.5% at screening
New York Heart Association functional heart failure class IV at screening
Use of mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders within 4 weeks prior to screening
History of stroke, transient ischemic attack, valve surgery, carotid surgery, acute coronary syndrome, or hospitalization for worsening heart failure within 3 months prior to randomisation
Severe liver impairment classified as Child-Pugh Class C
Documented history of adrenal insufficiency
Dialysis within 3 months prior to screening
Acute kidney injury within 3 months prior to screening
Use of prohibited concomitant medications

Research Team

AstraZeneca Clinical Study Information Center

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase IIb Study of Baxdrostat Combined With Dapagliflozin Versus Baxdrostat Alone to Reduce Albuminuria in Adults With Chronic Kidney Disease and High Blood Pressure

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria