Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia. (NCT07715318) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
40 participantsStarted 2026-12-01
Plain-language summary
The goal of this clinical trial is to learn if Spironolactone drug works to treat anemia in hemodialysis pediatric patients. It will also learn about the safety of Spironolactone drug. The main questions it aims to answer are:
In pediatric patients with anemia undergoing maintenance hemodialysis, does treatment with spironolactone, compared with standard care alone, reduce erythropoietin dose requirements while maintaining an acceptable safety profile? Researchers will compare Spironolactone drug to a standard therapy ((IV iron according to serum iron deficiency and patient's weight, epoetin after each session of dialysis according to the patient's weight) to see if Spironolactone drug works to treat anemia.
Participants will:
* Take Spironolactone drug daily for 12 weeks in addition to standard care.
* Continue their scheduled maintenance hemodialysis sessions.
* Undergo regular monitoring during dialysis visits, including clinical assessment and laboratory tests (e.g., hemoglobin, potassium, renal profile)
* Record any symptoms or side effects during the study period.
Who can participate
Age range
6 Years – 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
. Male or female patients with ages 6-18 years old undergoing regular hemodialysis (3 sessions per week for at least 6 months)
. Pediatric patients weighing between 25 kg and 50 kg.
. Patients with potassium level less than 5.5 mmol/L and produce urine.
. Anemic patients "have Hb values between 9.5 and 12.5 g/dl, transferrin saturation (TSAT) less than 20%)
. patients have been receiving stable rHuEpo therapy administered intravenously (IV) or subcutaneously (SC) for at least 8 weeks prior to randomization
. Patients suffering from iron- restricted erythropoiesis -
Exclusion criteria
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
erythropoietin-stimulating agents (ESAs) dose
Timeframe: baseline to 12 weeks.
Trial details
NCT IDNCT07715318
SponsorAin Shams University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-12-01
Contact for this trial
Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacy
. Patients with hyperkalemia (≥5.5 mmol/L) and hyponatremia (blood level less than135 mEq/L)
. Patients with liver disease (AST \& ALT greater than 3times upper limit normal)
. Patients with hypersensitivity to spironolactone.
. Patients scheduled for a living donor kidney transplant within 6 weeks following consent.
. Current or recently enrolled in another investigational drug study (within 30 days).
. Uncontrolled pre-dialysis supine diastolic blood pressure greater than the 95th percentile for height, gender, and age on more than two occasions in the 2 weeks prior to screening.