Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- erythropoietin-stimulating agents (ESAs) dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •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.
结局指标
主要结局
erythropoietin-stimulating agents (ESAs) dose
时间窗: baseline to 12 weeks.
Reduction in erythropoietin-stimulating agents (ESAs) dose
次要结局
- serum iron(Baseline to 12 weeks)
- Hemoglobin(Baseline to 12 weeks.)
- Transferrin Saturation (TSAT)(Baseline to 12weeks.)
研究者
Nouran Ahmed
Teaching Assistant
Heliopolis University