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A study to evaluate the effect of baxdrostat and dapagliflozin in reducing protein in the urine for patients with chronic kidney disease and high blood pressure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on individuals living with Chronic Kidney Disease, a condition where the kidneys do not work as well as they should, and Hypertension, which is high blood pressure. The research aims to determine if combining two different medications is more effective than using just one to reduce Albuminuria, a condition where a protein called albumin leaks into the urine. This leakage is often a sign of kidney damage.

Participants in the study may receive Baxdrostat, which is taken as an oral tablet, either by itself or combined with Dapagliflozin. In some cases, the medication Forxiga is used, which contains the active substance dapagliflozin. Some individuals may also receive a placebo instead of the second medication. This is a double-blind study, meaning that neither the participants nor the researchers know which specific treatment is being administered during the course of the trial.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry and medication administration
Participation begins with the administration of medication. depending on the assigned group, baxdrostat tablets will be taken by oral use.
The treatment involves a combination of baxdrostat and either dapagliflozin (10 mg film-coated tablets) or a placebo (an inactive substance used for comparison) taken by oral use.
Step 2
Monitoring and evaluation
The effects of the medication are monitored over a period of 12 weeks.
The primary measurement is the change in uacr, which refers to the urine albumin-to-creatinine ratio, a test used to check for albuminuria (the presence of a protein called albumin in the urine, which can indicate kidney disease).

Who can join the trial?

8 criteria

You must be at least 18 years old at the time you agree to join the study.
Your eGFR, which is a measure of how well your kidneys are filtering waste from your blood, must be between 30 and 90 mL/min/1.73 m2.
Your UACR, a test that measures the amount of albumin (a type of protein) in your urine, must be between 200 mg/g and 5000 mg/g.
You must have a history of hypertension, which is high blood pressure.
Your systolic blood pressure, which is the top number in a blood pressure reading, must be at least 130 mmHg during your initial screening and at least 120 mmHg when you are assigned to a study group.
If it is safe for you to take them, you must have been taking a stable, maximum daily dose of either an ACE inhibitor or an ARB (two different types of blood pressure medications) for at least 4 weeks before the study begins. You cannot be taking both.
Your potassium levels in your blood must be within specific ranges: between 3.0 and 4.8 mmol/L if your kidney function (eGFR) is 45 or higher, or between 3.0 and 4.5 mmol/L if your kidney function (eGFR) is below 45.
Female participants must use contraception (methods to prevent pregnancy) in a way that follows local rules for clinical study participants.

Who cannot join the trial?

12 criteria

Your systolic blood pressure (the top number in a blood pressure reading) is higher than 180 mmHg, or your diastolic blood pressure (the bottom number) is higher than 110 mmHg during the initial check.
You have used dialysis, which is a medical treatment that cleans your blood when your kidneys cannot do it themselves, within the last 3 months.
You have experienced acute kidney injury, which is a sudden episode of kidney failure or damage, within the last 3 months.
You are taking any prohibited concomitant medications, which are specific medicines that are not allowed to be taken at the same time as the study treatment.
You have hyperkalaemia, which means your blood has a high level of potassium (a mineral), measured at 5.5mmol/L or higher within the last 3 months.
Your serum sodium level, which is the amount of salt in your blood, is less than 135 mmol/L during your initial check.
You have Type 1 diabetes or uncontrolled Type 2 diabetes, which is diagnosed when your HbA1C (a measure of average blood sugar over time) is higher than 10.5%.
You have New York Heart Association functional HF class IV, which is the most severe stage of heart failure, meaning you have very limited ability to carry out physical activity.
You have used certain types of medications within the last 4 weeks, such as mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders.
You have had a stroke, a transient ischaemic cerebral attack (a temporary blockage of blood flow to the brain), valve implantation or replacement, carotid surgery, carotid angioplasty, acute coronary syndrome (a sudden reduction in blood flow to the heart), or were hospitalized for worsening heart failure within the last 3 months.
You have severe hepatic impairment, which means your liver is not working properly, specifically classified as Child-Pugh Class C.
You have a medical history of adrenal insufficiency, a condition where your adrenal glands do not produce enough essential hormones.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario De Navarra
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Pamplona, Spain
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
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Badalona, Spain
Medical Center Berbatov Ltd.
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Yambol, Bulgaria

Trial locations

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Investigated drugs

Baxdrostat
is a medication taken by mouth that is being studied to help manage high blood pressure and protect kidney function.
Dapagliflozin
is a medication taken by mouth that helps the body get rid of excess sugar through urine, which can help protect the kidneys in people with certain health conditions.

What is already known about the treatment

Baxdrostat
This medication is an oral tablet that is currently being studied in clinical trials for its potential to treat high blood pressure and kidney disease. It belongs to a class of drugs known as aldosterone synthase inhibitors, which work by blocking a specific enzyme in the body to reduce the production of a hormone that raises blood pressure. By lowering this hormone, the drug helps to relax blood vessels and reduce the strain on the kidneys.
Dapagliflozin
This medication is taken orally in the form of film-coated tablets and is already widely used in medicine to manage type 2 diabetes and protect kidney function. It is classified as an SGLT2 inhibitor, which works by preventing the kidneys from reabsorbing sugar back into the bloodstream, allowing excess sugar to be removed through urine. This process also helps lower blood pressure and reduces the workload on the kidneys, making it beneficial for patients with chronic kidney disease.

Investigated diseases

Chronic kidney disease
This condition occurs when the kidneys gradually lose their ability to filter waste products from the blood. As the disease progresses, the filtering units within the kidneys become damaged. This damage leads to an accumulation of fluids and waste in the body. Over time, the kidney function continues to decline steadily.
Hypertension
This is a condition where the force of the blood against the artery walls is consistently too high. It often develops over many years and may show no obvious signs initially. As it progresses, the constant pressure can cause damage to the blood vessels throughout the body. This can lead to changes in how organs like the heart and kidneys function.