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

NCT07715318 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2027-12-01
Completion
2028-03-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715318 on ClinicalTrials.gov