Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia. | NCT07715318

NCT07715318

Overview

NCT ID: NCT07715318
Lead Sponsor: Ain Shams UniversityOTHER
Official Title: Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
Brief Summary: 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.

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

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Central Contacts: Nouran Ahmed Abo El-Magd, Bachelor degree of pharmacyContact
nouran.ahmed21@pharma.asu.edu.eg