Oral Iron in Children With Chronic Kidney Disease

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Children's Hospital of Philadelphia
• Treatments: Iron

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