Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney… (NCT05735197) | Clinical Trial Compass
CompletedPhase 4
Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney Disease Patients
Egypt100 participantsStarted 2022-09-01
Plain-language summary
It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated.
Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2.
Participants will be randomized into two groups:
* Study group: includes 50 patients, they will receive Sodium glucose co-transporter 2 inhibitor (SGLT2i) as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
* Control group: includes 50 patients, they will receive placebo their medication.
The investigators will follow up all patients for 12 months and compare their results.
This study aims to:
1. Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease.
2. Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.
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
. Patients aged more than 18 year.
. CKD patient with eGFR from 25 to 75 ml/min/1.73m2 with no evidence of acute drop of the GFR in the last 3 months.
. Willing to sign informed consent.
Exclusion criteria
. eGFR less than 25 ml/min per 1.73 m2.
. Medical history of chronic disease (diabetes mellitus, chronic liver and/or respiratory diseases).
. Patients with primary or secondary glomerulonephritis/ nephrotic syndrome (proteinuria ≥ 3.5 gm/day) and/or any evidence of active immunological/ collagen vascular disease.
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.
. Inability to sign the study consent form or refusal to participate in the study.
. Evidence of urinary obstruction.
. Patients with evidence of volume depletion or receiving a combination of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBS)..
. Patients with current history of frequent hypotensive episodes or systolic blood pressure \<100 mmHg.
. Patients with history of recurrent urinary tract infection and/or valvovaginitis