This clinical trial is focused on studying the effects of a combination treatment for people with Chronic Kidney Disease (CKD) and high blood pressure. The study will use two medications: Baxdrostat and Dapagliflozin. Baxdrostat is a new medication being tested, while Dapagliflozin is already used to treat certain conditions. The purpose of the study is to find out if the combination of Baxdrostat and Dapagliflozin is more effective than Dapagliflozin alone in slowing down the progression of CKD.
Participants in the study will be randomly assigned to receive either the combination of Baxdrostat and Dapagliflozin, Dapagliflozin alone, or a placebo. The study will last for up to 26 weeks, during which participants will take the medication in the form of tablets by mouth. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The main focus will be on changes in kidney function, measured by a test called estimated glomerular filtration rate (eGFR), which helps assess how well the kidneys are working.
By participating in this study, researchers hope to gather important information about the safety and effectiveness of the combination treatment for people with CKD and high blood pressure. This could potentially lead to better treatment options in the future for managing these conditions. The study is designed to ensure the safety and well-being of all participants, with regular monitoring and support provided throughout the trial period.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney function, and blood pressure levels.
Participants must have chronic kidney disease (CKD) and high blood pressure, with specific measurements for kidney function and blood pressure.
2initial assessment
An initial assessment is conducted to establish baseline measurements. This includes evaluating kidney function through estimated glomerular filtration rate (eGFR) and urine albumin creatinine ratio (UACR).
Blood pressure is also measured to ensure it meets the study’s requirements.
3medication administration
Participants are randomly assigned to receive either a combination of baxdrostat and dapagliflozin or dapagliflozin alone.
Baxdrostat and dapagliflozin are administered orally in tablet form. The dosage and frequency are determined by the study protocol.
4ongoing monitoring
Regular monitoring is conducted to assess the progression of CKD and the effects of the medication.
This includes periodic measurements of eGFR, UACR, and blood pressure.
5end of treatment evaluation
At the end of the treatment period, a final evaluation is conducted to measure changes from baseline in eGFR and other health indicators.
The study aims to determine if the combination of baxdrostat and dapagliflozin is more effective than dapagliflozin alone in slowing CKD progression.
Who Can Join the Study?
Participants of any sex and gender must be 18 years old or older at the time of signing the informed consent.
Participants must have chronic kidney disease (CKD) with an eGFR (estimated glomerular filtration rate) between 30 and 90 mL/min/1.73 m² at screening. eGFR is a test that shows how well your kidneys are working.
Participants must have a urine albumin creatinine ratio greater than 200 mg/g (22.6 mg/mmol) and less than 5000 mg/g (565 mg/mmol) at screening. This test measures protein in your urine, which can indicate kidney problems.
Participants must have a history of hypertension (HTN), which means high blood pressure, and a systolic blood pressure (SBP) of at least 130 mmHg at screening and at least 120 mmHg at the randomization visit. SBP is the top number in a blood pressure reading.
Participants must be on a stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks before the screening visit. These are types of medications used to treat high blood pressure and kidney problems.
Participants must have a serum potassium level that meets specific criteria at the screening visit, based on their eGFR:
For participants with an eGFR of 45 mL/min/1.73 m² or higher, potassium must be between 3.5 and 4.8 mmol/L.
For participants with an eGFR less than 45 mL/min/1.73 m², potassium must be between 3.5 and 4.5 mmol/L.
Potassium is a mineral in your blood that needs to be at the right level for your body to function properly.
Who Cannot Join the Study?
Patients with severe liver disease cannot participate.
Individuals with a history of allergic reactions to the study drugs are excluded.
Pregnant or breastfeeding women are not allowed to join the study.
People with uncontrolled diabetes, meaning their blood sugar levels are not well-managed, cannot take part.
Participants who have had a heart attack or stroke in the past 6 months are excluded.
Individuals with a history of drug or alcohol abuse in the past year cannot participate.
Patients currently taking certain medications that might interfere with the study drugs are not eligible.
Anyone with a serious infection or illness that requires hospitalization is excluded.
Individuals with a history of cancer, except for certain types of skin cancer, cannot join the study.
Patients with a history of organ transplant are not eligible.
Baxdrostat is a medication being studied to see if it can help slow down the progression of chronic kidney disease (CKD) in people who also have high blood pressure. It is being tested in combination with another medication to see if it works better than the other medication alone.
Dapagliflozin is a medication that is already used to treat certain conditions, including chronic kidney disease and high blood pressure. In this study, it is being used to see how well it works on its own and in combination with another medication to slow down the progression of chronic kidney disease.
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. Over time, this can lead to a buildup of waste products in the body, causing symptoms like fatigue, swelling, and changes in urination. The disease progresses through stages, with each stage indicating a further decline in kidney function. As the condition advances, it can lead to complications such as high blood pressure, anemia, and bone disease. Monitoring kidney function through tests like eGFR is crucial to understanding the progression of the disease. Lifestyle changes and medications can help manage symptoms and slow progression.
Hypertension – Hypertension, commonly known as high blood pressure, is a condition where the force of the blood against the artery walls is consistently too high. This condition often develops over many years and can lead to serious health problems, such as heart disease and stroke, if left unmanaged. Hypertension is often called a “silent killer” because it may not present noticeable symptoms until significant damage has occurred. The progression of hypertension can lead to complications affecting the heart, brain, kidneys, and eyes. Regular monitoring of blood pressure is essential to detect and manage this condition effectively. Lifestyle changes and medications can help control blood pressure levels.
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