This clinical trial is focused on studying the effects of a new treatment for people with chronic kidney disease (CKD) and high blood pressure. The study will test a combination of two medications: Baxdrostat and Dapagliflozin. Baxdrostat is a new drug being tested, while Dapagliflozin is already used to treat certain conditions. The purpose of the study is to see if the combination of these two drugs is more effective than using Dapagliflozin alone in improving kidney health and reducing the risk of heart-related deaths.
Participants in the study will be randomly assigned to receive either the combination of Baxdrostat and Dapagliflozin or Dapagliflozin with a placebo. A placebo is a substance with no active medication. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, ensuring unbiased results. The treatment period will last up to 60 days, and participants will take the medication in the form of tablets.
The study aims to monitor the health of the participants over time, focusing on changes in kidney function and heart health. The researchers will look for any significant decline in kidney function, the need for dialysis or kidney transplant, and any heart-related deaths. The study will also track changes in blood pressure and other health markers. This research hopes to provide valuable insights into better treatment options for people with CKD and high blood pressure.
1joining the study
Upon joining the study, participants will be randomly assigned to one of two groups. One group will receive a combination of baxdrostat and dapagliflozin, while the other group will receive a placebo with dapagliflozin.
2medication administration
Participants will take the medications orally in the form of tablets. The exact dosage and frequency will be provided by the study team. The duration of medication administration will continue throughout the study period.
3regular health assessments
Participants will undergo regular health assessments to monitor kidney function and blood pressure. These assessments will help determine the effectiveness and safety of the treatment.
4monitoring and follow-up
Participants will be monitored for any changes in their health status. Follow-up visits will be scheduled to ensure the well-being of participants and to collect necessary data for the study.
5completion of the study
Upon completion of the study, participants will have a final assessment to evaluate the overall impact of the treatment. The study is estimated to end by May 20, 2030.
Who Can Join the Study?
Participants of any sex and gender must be at least 18 years old at the time of signing the informed consent.
Participants must have chronic kidney disease with specific kidney function levels:
eGFR (a measure of kidney function) between 30 and 60 mL/min/1.73 m² and UACR (a measure of protein in urine) between 30 mg/g and 500 mg/g, or
eGFR between 30 and 75 mL/min/1.73 m² and UACR between 500 mg/g and 5000 mg/g, or UPCR (another measure of protein in urine) between 700 mg/g and 7000 mg/g.
Participants must have a history of hypertension (high blood pressure) with a systolic blood pressure (SBP) of at least 130 mmHg within 4 weeks before screening or at the screening visit, and at least 120 mmHg at the randomization visit.
Participants must be on a stable and maximum tolerated dose of an ACE inhibitor or an ARB (types of blood pressure medications) for at least 4 weeks before the screening visit.
Participants must have specific levels of potassium in their blood:
Between 3.0 and 4.8 mmol/L if eGFR is 45 mL/min/1.73 m² or higher.
Between 3.0 and 4.5 mmol/L if eGFR is less than 45 mL/min/1.73 m².
Who Cannot Join the Study?
Patients with a history of severe allergic reactions to the study drugs cannot participate.
Patients who are currently pregnant or breastfeeding are not eligible.
Individuals with uncontrolled blood pressure, meaning their blood pressure is not well-managed with medication, are excluded.
Patients with a recent history of heart attack or stroke, which are serious heart and brain conditions, cannot join the study.
Those with severe liver disease, which affects how the body processes substances, are not allowed to participate.
Patients who have had a kidney transplant, meaning they have received a new kidney from a donor, are excluded.
Individuals with active cancer, which is a disease where cells in the body grow uncontrollably, cannot take part in the study.
Patients who are currently participating in another clinical trial are not eligible.
Individuals with a history of drug or alcohol abuse, which means using substances in a harmful way, are excluded.
Patients with any other medical condition that the study doctors believe would make participation unsafe are not allowed to join.
Baxdrostat is a medication being studied to see if it can help people with chronic kidney disease and high blood pressure. It is being tested to find out if it can reduce the risk of serious kidney problems or heart-related deaths when used together with another medication called dapagliflozin. The goal is to see if this combination can better protect the kidneys and heart compared to using dapagliflozin alone.
Dapagliflozin is a medication that is already used to help manage certain health conditions, like diabetes and heart failure. In this study, it is being used to see if it can help protect the kidneys and reduce the risk of heart-related deaths in people with chronic kidney disease and high blood pressure. Researchers are testing it both alone and in combination with another medication called baxdrostat to see which approach works better.
Chronic Kidney Disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses through stages, starting with mild damage and potentially advancing to severe kidney impairment. As the disease progresses, waste products can build up in the body, leading to symptoms such as fatigue, swelling, and high blood pressure. Over time, the kidneys may become unable to function effectively, which can result in the need for dialysis or a kidney transplant. The progression of chronic kidney disease can vary, with some individuals experiencing a slow decline in kidney function, while others may progress more rapidly. The disease is often associated with other health conditions, such as diabetes and hypertension, which can accelerate its progression.
Hypertension – Hypertension, also known as high blood pressure, is a condition where the force of the blood against the artery walls is consistently too high. This condition can develop over many years and often goes unnoticed due to the lack of symptoms. As hypertension progresses, it can cause damage to blood vessels and organs, particularly the heart, brain, kidneys, and eyes. Persistent high blood pressure can lead to complications such as heart disease, stroke, and kidney damage. The progression of hypertension can be influenced by factors such as age, lifestyle, and genetics. Managing blood pressure is crucial to prevent the long-term effects and complications associated with this condition.
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