drugset / Trial / NCT07715318

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

NCT07715318

Phase 2 Not yet recruiting 40 enrolled Ain Shams University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Spironolactone Small molecule

Indications