Pilot pragmatic clinical trial of iron therapy in children with anemia of chronic kidney disease (FeTCh-CKD)
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BACKGROUND: KDIGO 2012 anemia guidelines recommend oral iron as initial anemia therapy in children with pre-dialysis chronic kidney disease (CKD) when transferrin saturation (TSAT) < 20% and ferritin < 100 ng/mL, while also warning against over-prescribing iron. In this trial, we hypothesized that postponement of iron therapy for 12 weeks after these KDIGO criteria are met does not compromise the wellbeing of children with CKD with mild anemia. METHODS: Children with CKD II-IV, anemia, and iron deficiency as defined by KDIGO were rand.omized to iron sulfate therapy (n = 10) vs. no iron therapy (n = 11). Physical activity (assessed by PROMIS) was the primary outcome. Secondary outcomes included fatigue, grip strength, muscle mass, eating behavior, and hematologic parameters. RESULTS: At randomization, both groups had similar CKD severity, hemoglobin, iron, BMI, physical activity, muscle mass, grip strength, and eating behavior. After iron therapy, hemoglobin increased by 0.4 g/dL in the treated group and decreased by 0.1 g/dL in the non-treated group. In the treatment group, serum iron improved by 19.8 μg/dL, and TSAT improved by 7.1%. Differences in iron parameters between or within the groups did not reach statistical significance. Consistent with our hypothesis, there were no statistically significant differences in physical activity, fatigue, grip strength, muscle mass, or enjoyment of food between the groups after iron therapy. CONCLUSIONS: In this pilot trial, postponing iron therapy for 12 weeks did not compromise physical activity, muscle mass, muscle strength, or eating behavior in children with mild anemia of CKD compared to the KDIGO-recommended timing.