A Phase 2 interventional study of Spironolactone (drug) and Iron Supplement in Anemia, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment
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:
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 40 is below the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Ain Shams University is the lead sponsor of 1,953 studies on the registry; 430 are open to participants now.
Of its 35 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:
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.
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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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric hemodialysis patients receiving spironolactone in addition to standard care.
Drug: Spironolactone (drug) · Drug: Iron Supplement · Drug: Erythropoietin stimulating agent
pediatric hemodialysis patients receiving standard anemia management without spironolactone
Drug: Iron Supplement · Drug: Erythropoietin stimulating agent
Spironolactone is a potassium-sparing diuretic and mineralocorticoid receptor antagonist. It blocks the action of aldosterone and is commonly used in conditions such as heart failure, hypertension, and fluid retention. In this study, spironolactone is evaluated for its potential effect on anemia-related outcomes in pediatric patients receiving maintenance hemodialysis
Iron supplementation used as supportive therapy in anemic pediatric hemodialysis patients to optimize iron stores, improve iron availability for red blood cell production, and support the response to erythropoiesis-stimulating agents (ESAs)
Erythropoiesis-stimulating agent therapy used as standard treatment for anemia in patients with chronic kidney disease undergoing hemodialysis. ESAs stimulate red blood cell production by promoting erythropoiesis and are administered to maintain or improve hemoglobin levels.
erythropoietin-stimulating agents (ESAs) dose
Reduction in erythropoietin-stimulating agents (ESAs) dose
Time frame: baseline to 12 weeks.
serum iron
increase in level of serum iron
Time frame: Baseline to 12 weeks
Hemoglobin
increase level of hemoglobin
Time frame: Baseline to 12 weeks.
Transferrin Saturation (TSAT)
increase level of Transferrin Saturation (TSAT)
Time frame: Baseline to 12weeks.
No study locations are listed for this record.
Plan to share: No — The data are available from the primary investigator and will be shared upon reasonable request.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 88 phase 2 interventional studies under Anemia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 56. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spironolactone