Oral iron therapy for children with chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial investigates the effects of oral iron therapy using ferrous sulfate in children aged 1-21 years with chronic kidney disease (CKD) and mild anemia. Participants will be randomly assigned to receive either standard iron sulfate treatment or no iron therapy for a duration of three months. The study aims to evaluate outcomes such as muscle strength, physical activity, and changes in eating behavior, measured at the start and end of the trial. The goal is to determine the efficacy of oral iron in improving health metrics in this vulnerable population.

Why it matters

Who can join: the full rules

Key inclusion criteria:

* Age 1-21 years old (muscle strength will be assessed only in children \>3 year old)
* Estimated glomerular filtration rate (GFR) \< 90 ml/min/1.73m2 by bedside Schwartz formula \[height (cm) \*0.413 / serum creatinine (mg/dL)\]
* Hemoglobin (Hb) more or equal than 9.0 at the previous clinic visit
* Hb less than 11.5 g/dL in children younger than 5 years Hb less than 12.0 g/dL in children 5-12 years Hb \<12.5 g/dL in children 12-15 yrs and females \>15 yrs. Hb \<13.5 g/dL in males \>15 years (all at the previous clinic visit)

Children with transferrin saturation ≤ 20% AND serum ferritin ≤ 100 ng/mL will be randomized into one of the arms

Key exclusion criteria:

* Transferrin saturation \<5%
* Serum ferritin \< 10 ng/mL
* Iron therapy or erythrocyte stimulating agents (erythropoietin) therapy within 3 months prior to randomization
* Blood transfusion within 4 months prior to enrollment
* Children on hemodialysis
* Rapidly deteriorating kidney function or expectation for transplantation or dialysis in less than 3 months
* Pregnancy and breast-feeding

Where it's running

• Weill Cornell Medicine / New York Presbyterian Hospital
  New York, New York, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Oleh Akchurin, M.D. — Weill Cornell College of Medicine
• Study coordinator: Akeem Noziere, B.S.
• Email: akn4001@med.cornell.edu
• Phone: 646-962-8313

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.