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

ConditionAnemia

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age6-18

SponsorAin Shams University

About this trial

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.

Eligibility criteria

Qualifiers

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%)

Disqualifiers

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.

Trial design

Treatments tested in this trial

Spironolactone (drug)
Iron Supplement
Erythropoietin stimulating agent

Treatment groups

40 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Ain Shams University

Lead sponsor

Heliopolis University

Sponsor institution

Source ClinicalTrials.gov