A Phase 3 interventional study of Dapagliflozin (10Mg Tab) along with standard medical therapy and Placebo in Chronic Kidney Disease, Anemia and Cardiovascular Calcification, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Mansoura University · Phase 3, Interventional, and Treatment
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.
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 100 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive dapagliflozin 10 mg once daily plus standard CKD care.
Drug: Dapagliflozin (10Mg Tab) along with standard medical therapy
Participants receive placebo once daily plus standard CKD care
Other: Placebo
Drug page: Dapagliflozin
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.
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.
Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease
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.
Time frame: 12 months
Change in Hemoglobin
Change from baseline in hemoglobin levels (g/dL).
Time frame: 12 months
Change in Serum Hepcidin
Change from baseline in serum hepcidin levels (ng/mL).
Time frame: 12 months
Change in Erythropoietin (EPO)
Change from baseline in erythropoietin levels (mIU/mL).
Time frame: 12 months
Change in Left Ventricular Ejection Fraction (LVEF)
Change from baseline in LVEF assessed by echocardiography (percentage).
Time frame: 12 month
Change in Coronary Artery Calcium Score
Change from baseline in coronary artery calcium score (Agatston score).
Time frame: 12 month
Incidence of Major Adverse Cardiovascular Events (MACE)
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).
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data (IPD) will not be shared because of privacy concerns, regulatory restrictions, and the absence of a formal data-sharing infrastructure at the study site. De-identified aggregate results will be published, but raw participant-level data will not be made available to protect confidentiality.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin
Renal Insufficiency, Chronic →