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

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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)
• Препарат 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.

Первичные конечные точки

• erythropoietin-stimulating agents (ESAs) dose [Срок оценки: baseline to 12 weeks.]

Вторичные конечные точки (3)

• serum iron [Срок оценки: Baseline to 12 weeks]
• Hemoglobin [Срок оценки: Baseline to 12 weeks.]
• Transferrin Saturation (TSAT) [Срок оценки: Baseline to 12weeks.]

Критерии участия

Критерии включения

• 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 -

Критерии исключения

• 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.

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07715318 · ACUC -FP -ASU RHDIRB2020110301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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