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

NCT07715318 | Not Yet Recruiting Phase 2

• 1 other identifier: ACUC -FP -ASU RHDIRB2020110301
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anemia

Keywords

Spironolactone; pediatric hemodialysis; chronic kidney disease; end stage renal disease; anemia; erythropoietin; hemodialysis patients

Outcome Measures

Primary Outcomes (1)

• erythropoietin-stimulating agents (ESAs) dose

  Reduction in erythropoietin-stimulating agents (ESAs) dose

  baseline to 12 weeks.

Secondary Outcomes (3)

• serum iron

  Baseline to 12 weeks

• Hemoglobin

  Baseline to 12 weeks.

• Transferrin Saturation (TSAT)

  Baseline to 12weeks.

Study Arms (2)

Arm 1 ( Spironolactone group)

EXPERIMENTAL

Pediatric hemodialysis patients receiving spironolactone in addition to standard care.

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

Drug: Iron Supplement; Drug: Erythropoietin stimulating agent

Interventions

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

Arm 1 ( Spironolactone group)

Erythropoietin stimulating agent DRUG

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.

Arm 1 ( Spironolactone group); Arm 2 (control group)

Iron Supplement DRUG

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)

Arm 1 ( Spironolactone group); Arm 2 (control group)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Spironolactone; Pharmaceutical Preparations; Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Coordination Complexes; Dextrans; Glucans; Polysaccharides; Carbohydrates

Central Study Contacts

Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacy

CONTACT

+201014792219; nouran.ahmed21@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share