Impact of Sodium-Glucose Co-transporter 2 Inhibitors on Cardiovascular System and Anemia in Non-diabetic Chronic Kidney Disease Patients. A Randomized-Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease
研究概览
简要总结
The goal of this clinical trial is to learn if the drug dapagliflozin (an SGLT2 inhibitor) can help protect the kidneys, improve anemia, and support heart health in adults with chronic kidney disease (CKD) who do not have diabetes. The main questions it aims to answer are:
Does dapagliflozin slow the worsening of kidney function compared to standard care?
Does dapagliflozin improve anemia by increasing hemoglobin and related blood markers?
Does dapagliflozin improve heart function and reduce cardiovascular problems in CKD patients?
Researchers will compare dapagliflozin to a placebo (a look-alike pill with no active drug) to see if dapagliflozin works better than standard treatment alone.
Participants will:
Take dapagliflozin or a placebo once daily for 12 months, along with their usual CKD medications.
Visit the clinic every 3 months for checkups, blood tests, urine tests, and heart evaluations.
Have measurements of kidney function, anemia markers, and heart health taken at baseline and during follow-up visits.
详细描述
Chronic kidney disease (CKD) is a serious health problem that affects millions of people worldwide. It often leads to worsening kidney function, anemia (low blood count), and heart problems. While diabetes is a common cause of CKD, many patients develop kidney disease without having diabetes. These patients still face high risks of anemia and cardiovascular complications, but treatment options remain limited.
Dapagliflozin, a medicine from the sodium-glucose co-transporter 2 (SGLT2) inhibitor family, was originally developed to lower blood sugar in people with diabetes. However, recent large studies have shown that dapagliflozin can also protect the kidneys and improve heart health-even in patients who do not have diabetes. There is also evidence that this drug may help improve anemia by boosting the body's ability to make red blood cells.
This study is designed to test whether dapagliflozin can provide these benefits in adults with CKD who do not have diabetes. The trial will compare dapagliflozin to a placebo (a pill with no active drug) alongside standard medical care.
Key goals of the study are to learn:
Whether dapagliflozin slows the decline of kidney function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study is a randomized, double-blind, placebo-controlled trial. Participants, care providers, investigators, and outcomes assessors were all masked to treatment assignment. Study medications (dapagliflozin or placebo) are identical in appearance, packaging, and administration schedule to maintain blinding throughout the trial. Randomization codes were securely held and only revealed after study completion or in case of medical necessity.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years with a diagnosis of chronic kidney disease (CKD), non-diabetic etiology.
- •Estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73 m² at screening.
- •Stable standard CKD care for at least 3 months prior to enrollment.
- •Ability to provide written informed consent.
排除标准
- •Diagnosis of diabetes mellitus (type 1 or type 2).
- •History of kidney transplantation or currently on dialysis.
- •Acute kidney injury within the past 3 months.
- •Known hypersensitivity to dapagliflozin or excipients.
- •Pregnant or breastfeeding women.
- •Participation in another interventional clinical trial within the past 30 days.
- •Severe uncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, decompensated heart failure).
- •Any condition judged by the investigator to interfere with study participation or interpretation of results.
结局指标
主要结局
Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease
时间窗: 12 months
Composite outcome defined as ≥50% sustained decline in estimated glomerular filtration rate (eGFR) from baseline or reaching end-stage kidney disease requiring dialysis or transplantation.
次要结局
- Change in Hemoglobin(12 months)
- Change in Serum Hepcidin(12 months)
- Change in Erythropoietin (EPO)(12 months)
- Change in Left Ventricular Ejection Fraction (LVEF)(12 month)
- Change in Coronary Artery Calcium Score(12 month)
- Incidence of Major Adverse Cardiovascular Events (MACE)(12 months)
研究者
Mostafa Gamal Mosad Abu-Gharbia
Consultant Physician, Department of Nephrology and Kidney transplantation, Urology and Nephrology Center, Mansoura University
Mansoura University