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Oral Iron in Children With Chronic Kidney Disease

RecruitingPhase 4Ages 1 Year - 21 YearsAllWeill Medical College of Cornell University
NCT03991169 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a pilot clinical trial of oral iron therapy in children with chronic kidney disease (CKD) and mild anemia. Eligible children will be randomized into a standard of care (iron sulfate) arm vs. no iron therapy arm for 3 months. The outcomes will include muscle strength, physical activity, and changes in eating behavior, which will be measured at enrollment and at the end of the study period.

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📋 Eligibility rules (as published)
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
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What it tests

  • Ferrous Sulfate
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Where

2 sites
Weill Cornell Medicine / New York Presbyterian Hospital
New York, United States
Children's Hospital of Philadelphia
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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