AnemiaPhase 2NCT07715318
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
A Phase 2 study testing Spironolactone (drug), Iron Supplement and Erythropoietin stimulating agent in people with Anemia, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anemia
- What is being tested?
- Spironolactone (drug), Iron Supplement and Erythropoietin stimulating agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 -
Who cannot join
- Patients with acute renal insufficiency.
- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacy contact
About this study
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.
Read more
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.
- Conditions
- Anemia
- Being tested
- Spironolactone (drug), Iron Supplement, Erythropoietin stimulating agent
- Keywords
- Spironolactone, pediatric hemodialysis, chronic kidney disease, end stage renal disease, anemia, erythropoietin, hemodialysis patients
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spironolactone (drug)Drug
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 SupplementDrug
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)
Erythropoietin stimulating agentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 ( Spironolactone group) | Experimental | Pediatric hemodialysis patients receiving spironolactone in addition to standard care. Receives: Drug: Spironolactone (drug); Drug: Iron Supplement; Drug: Erythropoietin stimulating agent |
| Arm 2 (control group) | Active comparator | pediatric hemodialysis patients receiving standard anemia management without spironolactone Receives: Drug: Iron Supplement; Drug: Erythropoietin stimulating agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
erythropoietin-stimulating agents (ESAs) dose
Reduction in erythropoietin-stimulating agents (ESAs) dose
Measured: baseline to 12 weeks.
Secondary outcomes (3)
serum iron
increase in level of serum iron
Measured: Baseline to 12 weeks
Hemoglobin
increase level of hemoglobin
Measured: Baseline to 12 weeks.
Transferrin Saturation (TSAT)
increase level of Transferrin Saturation (TSAT)
Measured: Baseline to 12weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Ahmed, Heliopolis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715318
- Sponsor's protocol ID
- ACUC -FP -ASU RHDIRB2020110301
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are available from the primary investigator and will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
- ClinicalTrials.gov ID
- NCT07715318
- Acronym / sponsor ID
- ACUC -FP -ASU RHDIRB2020110301
- Conditions
- Anemia
- Keywords
- Spironolactone, pediatric hemodialysis, chronic kidney disease, end stage renal disease, anemia, erythropoietin, hemodialysis patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 ( Spironolactone group) | Experimental | Drug: Spironolactone (drug), Drug: Iron Supplement, Drug: Erythropoietin stimulating agentPediatric hemodialysis patients receiving spironolactone in addition to standard care. |
| Arm 2 (control group) | Active comparator | Drug: Iron Supplement, Drug: Erythropoietin stimulating agentpediatric hemodialysis patients receiving standard anemia management without spironolactone |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with acute renal insufficiency.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone (drug)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 | Drug | Arm 1 ( Spironolactone group) |
| Iron SupplementIron 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) | Drug | Arm 1 ( Spironolactone group), Arm 2 (control group) |
| Erythropoietin stimulating agentErythropoiesis-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. | Drug | Arm 1 ( Spironolactone group), Arm 2 (control group) |
Primary outcome
erythropoietin-stimulating agents (ESAs) dose
Time frame: baseline to 12 weeks.
Reduction in erythropoietin-stimulating agents (ESAs) dose
3 secondary outcomes
serum iron
Time frame: Baseline to 12 weeks
Hemoglobin
Time frame: Baseline to 12 weeks.
Transferrin Saturation (TSAT)
Time frame: Baseline to 12weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. The data are available from the primary investigator and will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacy contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone (drug), Iron Supplement and Erythropoietin stimulating agent in people with Anemia, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacy (+201014792219, nouran.ahmed21@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
erythropoietin-stimulating agents (ESAs) dose (time frame: baseline to 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.