Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07715318

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

  • 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.

-

Treatment and study plan

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.

Primary outcomes

  1. erythropoietin-stimulating agents (ESAs) dose

    Time frame: baseline to 12 weeks.

    Reduction in erythropoietin-stimulating agents (ESAs) dose

Secondary outcomes

  1. serum iron

    Time frame: Baseline to 12 weeks

    increase in level of serum iron

  2. Hemoglobin

    Time frame: Baseline to 12 weeks.

    increase level of hemoglobin

  3. Transferrin Saturation (TSAT)

    Time frame: Baseline to 12weeks.

    increase level of Transferrin Saturation (TSAT)

Study contacts

Contact information is provided by the study sponsor or research team.

Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacy

CONTACT

[email protected]

+201014792219

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.