Abstract
BackgroundThe main hypothesis of this study is that oral heme iron polypeptide (HIP; Proferrin® ES) administration will more effectively augment iron stores in erythropoietic stimulatory agent (ESA)-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation (Ferrogradumet®).MethodsInclusion criteria are peritoneal dialysis patients treated with darbepoietin alpha (DPO; Aranesp®, Amgen) for ≥ 1 month. Patients will be randomized 1:1 to receive either slow-release ferrous sulphate (1 tablet twice daily; control) or HIP (1 tablet twice daily) for a period of 6 months. The study will follow an open-label design but outcome assessors will be blinded to study treatment. During the 6-month study period, haemoglobin levels will be measured monthly and iron studies (including transferring saturation [TSAT] measurements) will be performed bi-monthly. The primary outcome measure will be the difference in TSAT levels between the 2 groups at the end of the 6 month study period, adjusted for baseline values using analysis of covariance (ANCOVA). Secondary outcome measures will include serum ferritin concentration, haemoglobin level, DPO dosage, Key's index (DPO dosage divided by haemoglobin concentration), and occurrence of adverse events (especially gastrointestinal adverse events).DiscussionThis investigator-initiated multicentre study has been designed to provide evidence to help nephrologists and their peritoneal dialysis patients determine whether HIP administration more effectively augments iron stores in ESP-treated PD patients than conventional oral iron supplementation.Trial RegistrationAustralia New Zealand Clinical Trials Registry number ACTRN12609000432213.
Highlights
The main hypothesis of this study is that oral heme iron polypeptide (HIP; Proferrin® ES) administration will more effectively augment iron stores in erythropoietic stimulatory agent (ESA)-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation (Ferrogradumet®)
Several investigations, including a randomised controlled trial, have consistently demonstrated that intravenous iron supplementation is superior to oral iron replacement with respect to enhancing body iron stores, augmenting haemoglobin levels and reducing EPO requirements [5,6,7]
Other investigators have demonstrated that oral iron supplements are unable to maintain adequate iron stores in PD patients over medium-to-long term periods [5], principally because of poor compliance, gastrointestinal side effects, suboptimal gastrointestinal absorption of iron, and medication costs [9]
Summary
The main hypothesis of this study is that oral heme iron polypeptide (HIP; Proferrin® ES) administration will more effectively augment iron stores in erythropoietic stimulatory agent (ESA)-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation (Ferrogradumet®). Other investigators have demonstrated that oral iron supplements are unable to maintain adequate iron stores in PD patients over medium-to-long term periods [5], principally because of poor compliance, gastrointestinal side effects, suboptimal gastrointestinal absorption of iron ( in the presence of an acute phase response and high ferritin levels), and medication costs [9] In spite of this evidence, many authors [10,11,12] and clinical practice guidelines [13,14,15] have recommended oral iron supplementation for PD patients in the first instance, because of its greater simplicity, lower cost and avoidance of the need for repeated intravenous cannulation
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