Actively Recruiting
Oral Iron in Children With Chronic Kidney Disease
Led by Weill Medical College of Cornell University · Updated on 2025-08-11
40
Participants Needed
2
Research Sites
506 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral Iron in Children With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1-21 years old (muscle strength assessed only in children older than 3 years)
- Estimated glomerular filtration rate (GFR) below 90 ml/min/1.73m2 by bedside Schwartz formula
- Hemoglobin (Hb) of 9.0 or higher 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 less than 12.5 g/dL in children 12-15 years and females older than 15 years
- Hb less than 13.5 g/dL in males older than 15 years
- Transferrin saturation 20% or less AND serum ferritin 100 ng/mL or less
You will not qualify if you...
- Transferrin saturation less than 5%
- Serum ferritin less than 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 worsening kidney function or expected transplantation or dialysis within 3 months
- Pregnancy and breast-feeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, United States, 10065
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
A
Akeem Noziere, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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