NCT07715318Not yet recruitingPhase 2
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 Jul 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- Ain Shams University
- Diseases
- Chronic kidney disease
- NCT number
- NCT07715318
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Dec 2026 to the primary completion date, 1 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- \-
Other illness
- Patients with acute renal insufficiency.
- Patients with hypersensitivity to spironolactone.
Lab values
- 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)
Who the study is looking for
- 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 -
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.