Chronic Kidney Disease, Anemia, Cardiovascular Calcification
Conditions
Keywords
dapagliflozin, Anemia, vascular calcification
Brief summary
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.
Detailed description
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. Whether it improves anemia by increasing hemoglobin and related blood markers. Whether it improves heart health, including heart function and blood vessel changes. How safe dapagliflozin is for patients with CKD who do not have diabetes. How the study works: About 100 adults with CKD will take part. Participants will be randomly assigned to receive either dapagliflozin or a placebo, in addition to their usual medications. The treatment will last for 12 months. Participants will visit the clinic every 3 months for checkups, blood and urine tests, and heart evaluations such as echocardiography and ECG. At the end of the study, researchers will compare kidney function, anemia markers, and heart health between the two groups. Why this study matters: If dapagliflozin proves effective, it could become an important new option for patients with CKD who do not have diabetes. This would mean better kidney outcomes, fewer complications from anemia, and improved heart health for a large group of patients who currently have limited treatment choices.
Interventions
Participants will receive dapagliflozin 10 mg oral tablet once daily, with or without food, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.
OTHERPlacebo
Participants will receive a placebo oral tablet once daily, identical in appearance to dapagliflozin but containing no active drug, in addition to standard chronic kidney disease care. Treatment will continue for 12 months.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
This is a randomized, double-arm, parallel assignment clinical trial. A total of 100 adults with non-diabetic chronic kidney disease (CKD) will be enrolled and randomly assigned in equal numbers to one of two groups: Intervention group: Participants will receive dapagliflozin 10 mg once daily in addition to standard CKD care. Control group: Participants will receive a placebo once daily in addition to standard CKD care. Both groups will be followed in parallel for 12 months. Outcomes related to kidney function, anemia, and cardiovascular health will be compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) | 12 month | Change from baseline in LVEF assessed by echocardiography (percentage). |
| Change in Coronary Artery Calcium Score | 12 month | Change from baseline in coronary artery calcium score (Agatston score). |
| Change in Erythropoietin (EPO) | 12 months | Change from baseline in erythropoietin levels (mIU/mL). |
| Change in Hemoglobin | 12 months | Change from baseline in hemoglobin levels (g/dL). |
| Change in Serum Hepcidin | 12 months | Change from baseline in serum hepcidin levels (ng/mL). |
| Incidence of Major Adverse Cardiovascular Events (MACE) | 12 months | Number of participants with at least one Major Adverse Cardiovascular Event, defined as a composite of: myocardial infarction, stroke, or hospitalization for heart failure (Participants). |
Countries
Egypt
Outcome results
None listed