Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT03991169
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
21 Years
Study:
NCT03991169
Study Brief:
Protocol Section:
NCT03991169