SGLT2 Inhibitors in Non-Diabetic CKD: Effects on Vascular Calcification and Anemia (NCT07344922) | Clinical Trial Compass
CompletedPhase 3
SGLT2 Inhibitors in Non-Diabetic CKD: Effects on Vascular Calcification and Anemia
Egypt100 participantsStarted 2022-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to first occurrence of sustained decline in kidney function or progression to end-stage kidney disease