This clinical trial is focused on studying the effects of a medication called dapagliflozin on patients with severe chronic kidney disease (CKD). Chronic kidney disease is a long-term condition where the kidneys do not work as well as they should. The study will also look at how this medication affects heart health, specifically in terms of reducing the risk of heart failure and overall mortality, which means the risk of death from any cause.
The purpose of the study is to determine if dapagliflozin is more effective than a placebo in improving kidney and heart health outcomes. Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will include patients with advanced CKD, those on dialysis, and kidney transplant recipients. The trial will monitor the time it takes for participants to experience kidney failure, hospitalization due to heart failure, or death from any cause.
Throughout the study, participants will take the medication or placebo orally, in the form of a film-coated tablet, for a period of up to 48 weeks. The study aims to provide valuable insights into whether dapagliflozin can help improve the health and quality of life for people with severe chronic kidney disease by potentially reducing the risk of kidney failure and heart-related issues.
1joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. These include having advanced chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73m² or less, being on dialysis with residual urine output of 500 mL/24 hours or more, or being a kidney transplant recipient with an eGFR of 45 mL/min/1.73m² or less.
Participants must be 18 years or older and willing to sign an informed consent form. Pre-dialysis patients must be on a stable dose of ACE inhibitors or ARBs for at least four weeks before the screening visit, unless they cannot tolerate these medications.
2randomization
Participants are randomly assigned to receive either dapagliflozin or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication or the placebo.
3medication administration
Participants take the assigned medication orally. The dosage for dapagliflozin is 10 mg in the form of film-coated tablets. The frequency and duration of administration are determined by the study protocol and continue throughout the trial period.
4monitoring and follow-up
Participants are monitored for the occurrence of the primary composite endpoint, which includes kidney failure, hospitalization for heart failure, and all-cause mortality. Secondary endpoints include time to kidney failure, time to first heart failure hospitalization, and time to all-cause death.
Regular follow-up visits are scheduled to assess health status and any side effects of the medication.
5completion of the trial
The trial is estimated to end by March 31, 2027. Upon completion, data from all participants are analyzed to determine the effectiveness of dapagliflozin compared to the placebo in reducing the incidence of the primary and secondary endpoints.
Who Can Join the Study?
Patients must have one of the following conditions:
Advanced CKD (Chronic Kidney Disease) with an eGFR (a test that measures kidney function) of 25 or less.
Patients on hemo- or peritoneal dialysis with a residual diuresis (remaining urine output) of 500 mL or more per day, at least 3 months after starting dialysis.
Kidney transplant recipients with an eGFR of 45 or less, at least 6 months after transplantation.
Participants must be 18 years of age or older.
Participants must be willing to sign an informed consent form, which is a document that explains the study and confirms their agreement to participate.
Pre-dialysis patients with an eGFR of 25 or less must be on a stable dose of ACEis (Angiotensin-Converting Enzyme inhibitors) or ARBs (Angiotensin Receptor Blockers) for at least 4 weeks before the screening visit, unless they cannot tolerate these medications. They should continue their stable doses throughout the trial if possible and tolerated. This requirement does not apply to patients on maintenance dialysis or kidney transplant recipients.
Who Cannot Join the Study?
Patients who have a severe allergy to the study medication or any of its ingredients.
Patients who are currently participating in another clinical trial.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse that could interfere with the study.
Patients who have had a recent heart attack or stroke.
Patients who have uncontrolled high blood pressure.
Patients who have a serious infection that requires treatment.
Patients who have a history of cancer within the last five years, except for certain types of skin cancer.
Patients who have a mental health condition that could interfere with their ability to follow study instructions.
Dapagliflozin is a medication used in this trial to see if it can help improve kidney and heart health in people with severe chronic kidney disease. The study aims to find out if dapagliflozin can lower the chances of kidney failure, reduce hospital visits due to heart failure, and decrease the risk of death from any cause in the patients participating in the trial.
Chronic Kidney Disease – This condition involves the gradual loss of kidney function over time. As the disease progresses, the kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. Symptoms may not appear until significant damage has occurred, and they can include fatigue, swelling in the legs and ankles, and changes in urination patterns. In advanced stages, kidney failure may occur, requiring dialysis or a kidney transplant.
Heart Failure – This condition occurs when the heart is unable to pump blood effectively to meet the body’s needs. It can develop over time as the heart becomes weakened or stiff, often due to conditions like high blood pressure or coronary artery disease. Symptoms may include shortness of breath, fatigue, and swelling in the legs and abdomen. As heart failure progresses, these symptoms can worsen, leading to increased difficulty in performing daily activities and a higher risk of hospitalization.
All-Cause Mortality – This term refers to death from any cause, not limited to a specific disease or condition. It is often used in studies to measure the overall risk of death in a population. Factors contributing to all-cause mortality can include chronic diseases, acute medical events, and external factors such as accidents. Monitoring all-cause mortality helps in understanding the overall health impact of various conditions and treatments.
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