Intermittent versus maintenance iron therapy in children on hemodialysis: a randomized study

Abstract

In patients with renal anemia, iron therapy can be administered intermittently or regularly at a low dose. We performed a randomized clinical trial in pediatric patients with end-stage renal failure on hemodialysis and absolute or functional iron deficiency. The study group received maintenance iron therapy according to the ferritin serum levels and the control group received intermittent 10-weekly doses. Success was defined as stabilization of ferritin levels between 100 and 800 microg/l and transferrin saturation (TSAT) between 20% and 50%, in addition to an increase in the hemoglobin level. The major reason for exclusion was iron overload. The study group received 6 mg/kg per month of parenteral iron [95% confidence interval (CI) 3.3-8.8] and the control group 14.4 mg/kg per month (95% CI 12-16.8) ( P<0.001). After 4 months of treatment, ferritin levels increased to 66 microg/l (95% CI 69-200) in the study group and to 334 microg/l (95% CI 145-522) in the control group ( P=0.009). Maintenance therapy and intermittent weekly doses were successful in 73% and 38%, respectively. After 3 months of treatment, hemoglobin levels increased to 10 g/dl, with no difference between the groups. However, in the control group the increase in hemoglobin levels was unsustained, and 3 patients needed transfusion. Patients in the control group had a higher risk of iron overload than patients in the study group (70% vs. 19%). Thus, the regimen based on assessment of serum ferritin levels was more efficient than the intermittent regimen because it increased and maintained the hemoglobin levels with lower iron doses and a lower risk of iron overload.

Report of an NIH task force on research priorities in chronic kidney disease in children

“…Iron management also deserves attention, with reference to the issues of intravenous (IV) versus oral (PO) therapy (and if IV therapy, what is the optimal preparation), defining optimal monitoring parameters and target values for iron management, and the impact of IV iron therapy on neutrophil function and oxidative stress [78,79,80,81].…”

Iron therapy in the pediatric hemodialysis population

“…Another potential reason for caution regarding the use of IV iron in children may be the risk of iron overload. Whereas serum ferritin levels >800 ng/ml have not been reported in either iron-deficient or iron-replete pediatric patients enrolled in the prior published IV iron studies [15,24,25,26,28], the safe upper limit for SF in pediatric patients has not been well established [13] and the optimal dose of IV iron required to maintain pediatric patients in an iron-replete state and improve responsiveness to r-HuEPO without causing iron overload has yet to be determined.…”

“…While there have been several studies evaluating the efficacy of maintenance IV iron in adult HD patients, information is limited in the pediatric population [15,28]. Accordingly, the objective of the current study was to compare the efficacy and safety of maintenance IV iron versus oral iron supplementation in pediatric patients with ESRD receiving chronic HD and r-HuEPO therapy.…”

Annual Iron Loss Associated with Hemodialysis

“…Hb cycling, which might be related to cardiovascular events, has also been induced by intensive iron supplementation [24,25] . The second mode of iron supplementation is periodic minimum iron repletion, which helps maintain a constant iron status by supplying the same amount of iron intravenously that is lost through the hemodialysis procedure [21,26] . This may be the more physiological of the 2, as iron absorption from food is not sufficient to maintain iron status in chronic hemodialysis patients even when oral iron supplementation is prescribed [27,28] .…”