Abstract

BackgroundAnemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease (ND-CKD) but it is unclear if oral supplementation is as effective as intravenous (IV) supplementation in re-establishing iron stores. The purpose of this study was to determine if oral Heme Iron Polypeptide (HIP) is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with ND-CKD.MethodsForty ND-CKD patients were randomized; 18 to HIP 11 mg orally 3 times per day and 22 to IV iron sucrose 200 mg monthly for 6 months. Baseline clinical and laboratory data were collected for all patients. The primary and secondary outcomes for the study were hemoglobin (Hgb) concentration and iron indices [ferritin and percentage transferrin saturation (TSAT)] at the end of 6 months respectively. Adverse events were also compared.ResultsThe baseline demographic characteristics and laboratory values were similar for the two groups. After 6 months of treatment, Hb in the HIP group was 117 g/L and 113 g/L in the IV sucrose group (p = 0.37). The TSAT at 6 months was not different between the two groups {p = 0.82}but the serum ferritin was significantly higher in the IV iron sucrose group {85.5 ug/L in HIP and 244 ug/L; p = 0.004}. Overall adverse events were not different between the groups.ConclusionHIP is similar in efficacy to IV iron sucrose in maintaining hemoglobin in ND-CKD patients with no differences in adverse events over 6 months. It is unclear if the greater ferritin values in the IV iron sucrose group are clinically significant.Trial registrationClinicalTrials.gov: NCT00318812

Highlights

  • Anemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease (ND-CKD) but it is unclear if oral supplementation is as effective as intravenous (IV) supplementation in re-establishing iron stores

  • We examined the requirement for erythropoietin and adverse events with the medication

  • The estimated glomerular filtration rate (eGFR) was comparable between both groups {20.5 ml/min/ 1.73 m2 (IQR:12–26) in Heme Iron Polypeptide (HIP) and 23 ml/min/1.73 m2 (IQR:18–33) in IV iron sucrose group}

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Summary

Introduction

Anemia secondary to iron deficiency is common in patients with non-dialysis dependent chronic kidney disease (ND-CKD) but it is unclear if oral supplementation is as effective as intravenous (IV) supplementation in re-establishing iron stores. The purpose of this study was to determine if oral Heme Iron Polypeptide (HIP) is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with ND-CKD. Iron deficiency is common in patients with CKD which limits the effectiveness of erythropoiesis-stimulating agents (ESA) [4,5,6,7]. The main adverse reactions to oral iron are gastrointestinal and may limit adherence and dose [12]. The most feared adverse reaction to IV iron is anaphylaxis, which is more common with iron dextran than with other preparations [13,14]. There are concerns that IV iron may accelerate kidney damage in patients with CKD not on dialysis therapy, promote infections by supplying iron to pathogenic bacteria, enhance atherosclerosis by generating oxidative stress, and cause endothelial damage [15,16,17,18]

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