Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.

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 Overview

• Status: Not yet recruiting
• Conditions: Anemia
• Intervention / Treatment: Drug: Spironolactone (drug); Drug: Iron Supplement; Drug: Erythropoietin stimulating agent

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacy; Phone Number: +201014792219; Email: nouran.ahmed21@pharma.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female patients with ages 6-18 years old undergoing regular hemodialysis (3 sessions per week for at least 6 months)
2. Pediatric patients weighing between 25 kg and 50 kg.
3. Patients with potassium level less than 5.5 mmol/L and produce urine.
4. Anemic patients "have Hb values between 9.5 and 12.5 g/dl, transferrin saturation (TSAT) less than 20%)
5. patients have been receiving stable rHuEpo therapy administered intravenously (IV) or subcutaneously (SC) for at least 8 weeks prior to randomization
6. Patients suffering from iron- restricted erythropoiesis -

Exclusion Criteria:

1. Patients with acute renal insufficiency.
2. Patients with hyperkalemia (≥5.5 mmol/L) and hyponatremia (blood level less than135 mEq/L)
3. Patients with liver disease (AST & ALT greater than 3times upper limit normal)
4. Patients with hypersensitivity to spironolactone.
5. Patients scheduled for a living donor kidney transplant within 6 weeks following consent.
6. Current or recently enrolled in another investigational drug study (within 30 days).

7. 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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 ( Spironolactone group); Pediatric hemodialysis patients receiving spironolactone in addition to standard care.	Drug: 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: Iron Supplement; 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); Drug: Erythropoietin stimulating agent; 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.
Active Comparator: Arm 2 (control group); pediatric hemodialysis patients receiving standard anemia management without spironolactone	Drug: Iron Supplement; 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); Drug: Erythropoietin stimulating agent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
erythropoietin-stimulating agents (ESAs) dose	Reduction in erythropoietin-stimulating agents (ESAs) dose	baseline to 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum iron	increase in level of serum iron	Baseline to 12 weeks
Hemoglobin	increase level of hemoglobin	Baseline to 12 weeks.
Transferrin Saturation (TSAT)	increase level of Transferrin Saturation (TSAT)	Baseline to 12weeks.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: anemia; chronic kidney disease; erythropoietin; Spironolactone; end stage renal disease; hemodialysis patients; pediatric hemodialysis
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Hematologic Diseases; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic; Anemia; Organic Chemicals; Carbohydrates; Polycyclic Compounds; Coordination Complexes; Pregnanes; Steroids; Fused-Ring Compounds; Lactones; Polysaccharides; Pregnenes; Glucans; Dextrans; Spironolactone; Iron-Dextran Complex; Pharmaceutical Preparations
• Other Study ID Numbers: ACUC -FP -ASU RHDIRB2020110301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data are available from the primary investigator and will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No