A randomized controlled trial of oral heme iron polypeptide versus oral iron supplementation for the treatment of anaemia in peritoneal dialysis patients: HEMATOCRIT trial

Barraclough, Katherine A.; Brown, Fiona G.; Hawley, Carmel M.; Leary, D. R.; Noble, Euan; Campbell, Scott; Isbel, Nicole M.; Mudge, David W.; Eps, C. L. Van; Johnson, David W.

doi:10.1093/ndt/gfs372

Cited by 29 publications

(26 citation statements)

References 26 publications

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“…However, similar to previous randomized studies, the serum ferritin was significantly higher in IV iron group, in spite of similar TSATs in the HIP group. A similar result was seen in the recently completed HEMATOCRIT trial in which the serum ferritin was also higher in peritoneal dialysis patients treated with ferrous sulfate compared to HIP [38]. It is unclear if the increased ferritin is clinically significant.…”

Section: Discussionsupporting

confidence: 68%

Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial

et al. 2013

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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

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Section: Discussionsupporting

confidence: 68%

Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial

et al. 2013

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“…103 To date, pharmaceutical filing and published trials have not demonstrated anaphylactic reactions with intradialytic administration of soluble ferric pyrophosphate 104 or oral ferric citrate 105 or with another iron compound currently under development, heme iron polypeptide. 106 However, given the rarity of reactions with any form of iron administration, it cannot be concluded that oral or intradialytic administration of iron is without risk.…”

Section: Table 4 | Research Recommendationsmentioning

confidence: 99%

Iron management in chronic kidney disease: conclusions from a “Kidney Disease: Improving Global Outcomes” (KDIGO) Controversies Conference

Macdougall

Bircher

Eckardt

et al. 2016

Kidney International

308

236

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Before the introduction of erythropoiesis-stimulating agents (ESAs) in 1989, repeated transfusions given to patients with end-stage renal disease caused iron overload, and the need for supplemental iron was rare. However, with the widespread introduction of ESAs, it was recognized that supplemental iron was necessary to optimize hemoglobin response and allow reduction of the ESA dose for economic reasons and recent concerns about ESA safety. Iron supplementation was also found to be more efficacious via intravenous compared to oral administration, and the use of intravenous iron has escalated in recent years. The safety of various iron compounds has been of theoretical concern due to their potential to induce iron overload, oxidative stress, hypersensitivity reactions, and a permissive environment for infectious processes. Therefore, an expert group was convened to assess the benefits and risks of parenteral iron, and to provide strategies for its optimal use while mitigating the risk for acute reactions and other adverse effects.

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“…Recently, a nanoparticulate mimetic of the ferritin core was proposed as a potentially side effect-free form of supplemental iron [ 27 ] and a paediatric trial is ongoing (NCT02941081). Other trials are on-going with many different oral iron formulations developed to improve absorption and/or tolerability [ 14 , 23 , 28 , 29 , 30 ].…”

Section: Iron Deficiency Anaemiamentioning

confidence: 99%

Intravenous Irons: From Basic Science to Clinical Practice

et al. 2018

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Iron is an essential trace mineral necessary for life, and iron deficiency anaemia (IDA) is one of the most common haematological problems worldwide, affecting a sixth of the global population. Principally linked to poverty, malnutrition and infection in developing countries, in Western countries the pathophysiology of IDA is primarily linked to blood loss, malabsorption and chronic disease. Oral iron replacement therapy is a simple, inexpensive treatment, but is limited by gastrointestinal side effects that are not inconsequential to some patients and are of minimal efficacy in others. Third generation intravenous (IV) iron therapies allow rapid and complete replacement dosing without the toxicity issues inherent with older iron preparations. Their characteristic, strongly-bound iron-carbohydrate complexes exist as colloidal suspensions of iron oxide nanoparticles with a polynuclear Fe(III)-oxyhydroxide/oxide core surrounded by a carbohydrate ligand. The physicochemical differences between the IV irons include mineral composition, crystalline structure, conformation, size and molecular weight, but the most important difference is the carbohydrate ligand, which influences complex stability, iron release and immunogenicity, and which is a unique feature of each drug. Recent studies have highlighted different adverse event profiles associated with third-generation IV irons that reflect their different structures. The increasing clinical evidence base has allayed safety concerns linked to older IV irons and widened their clinical use. This review considers the properties of the different IV irons, and how differences might impact current and future clinical practice.

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A randomized controlled trial of oral heme iron polypeptide versus oral iron supplementation for the treatment of anaemia in peritoneal dialysis patients: HEMATOCRIT trial

Cited by 29 publications

References 26 publications

Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial

Heme iron polypeptide for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients: a randomized controlled trial

Iron management in chronic kidney disease: conclusions from a “Kidney Disease: Improving Global Outcomes” (KDIGO) Controversies Conference

Intravenous Irons: From Basic Science to Clinical Practice

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