NCT03991169PHASE4Recruiting
Oral Iron in Children With Chronic Kidney Disease
Weill Medical College of Cornell University
Start Date
4/19/2019
Completion Date
12/31/2028
Summary
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.
Eligibility Criteria
Age Range: 1 years to 21 years
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
Interventions
DRUG
Ferrous Sulfate
Conditions
Chronic Kidney InsufficiencyChronic Kidney Diseases
Locations
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York 10065
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States