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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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)

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm 1 ( Spironolactone group)Experimental treatment 3 interventions
Group B: Arm 2 (control group)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

erythropoietin-stimulating agents (ESAs) dose

Reduction in erythropoietin-stimulating agents (ESAs) dose

Time frame
baseline to 12 weeks.

Secondary outcomes

1

serum iron

increase in level of serum iron

Time frame
Baseline to 12 weeks
2

Hemoglobin

increase level of hemoglobin

Time frame
Baseline to 12 weeks.
3

Transferrin Saturation (TSAT)

increase level of Transferrin Saturation (TSAT)

Time frame
Baseline to 12weeks.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Heliopolis University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: