55 - Pilot pragmatic clinical trial of oral iron therapy in children with chronic kidney disease (FeTCh-CKD): initial findings

Anemia is a common complication of chronic kidney disease (CKD) in children, often associated with functional iron (Fe) deficiency. Based on expert opinions, KDOQI guides Fe therapy when transferrin saturation (TSAT) < 20% and ferritin < 100 ng/mL. However, Fe therapy may adversely affect inflammation, oxidative stress, and bone health in CKD. In this non-inferiority trial, we hypothesized that after children with mild anemia of CKD reach the above TSAT and ferritin cutoffs, Fe therapy can be safely postponed for 12 weeks without compromising their well-being.

Objective:

Compare physical activity and well-being metrics in children with mild anemia of CKD not receiving iron therapy (noFe group) vs. receiving immediate iron therapy (Fe group) over 12 weeks.

Design/Methods:

Table 1 shows inclusion/exclusion criteria for this ongoing randomized open-label pilot pragmatic clinical trial (NCT03991169). Post-randomization, Fe-group received Fe sulfate, 3-6 mg/kg/day, vs. no Fe therapy in noFe group. Failure to increase in serum Fe or TSAT after Fe therapy defined noncompliance. Physical activity after 12 weeks (assessed by PROMIS surveys) was the primary outcome. Secondary outcomes included fatigue (assessed by PROMIS), grip strength, muscle mass (bioelectrical impedance analysis, BIA), eating behavior (Child Eating Behavior Questionnaire, CEBQ), and hematologic parameters. Comparisons were performed using χ² and t tests.

Results:

Of 28 enrolled participants, 16 were randomized: 10 Fe group, 6 noFe group. At baseline, groups had similar CKD severity, hemoglobin, iron status, BMI, height z-score, physical activity, muscle mass, grip strength, and eating behavior (Table 2). One participant was noncompliant with iron therapy.

After 12 weeks, both groups had similar physical activity, grip strength, muscle mass, and enjoyment of food (Table 3). Fatigue trended favorably in Fe group as per parental proxy reports. Median hemoglobin increased 0.4 g/dL in Fe group and decreased 0.4 g/dL in noFe group. Within Fe group, serum Fe increased by 19.0 μg/dL, and TSAT by 4.6% (median values; p=0.003 and p=0.008 respectively).

Conclusion(s):

Although our preliminary data suggest improvement in hematologic parameters after Fe therapy, postponement of therapy for 3 months did not negatively affect well-being outcomes in children with mild anemia of CKD in a statistically or clinically significant manner. Larger trials are needed to optimize criteria for iron therapy initiation in children with CKD.