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Title: | A randomized controlled trial of oral heme iron polypeptide versus oral iron supplementation for the treatment of anaemia in peritoneal dialysis patients: HEMATOCRIT trial. | Authors: | Johnson D.W.;Brown F.;Hawley C.M.;Leary D.;Noble E.;Campbell S.B.;Isbel N.M.;Mudge D.W.;Van Eps C.L.;Barraclough K.A. | Institution: | (Barraclough, Hawley, Leary, Noble, Campbell, Isbel, Mudge, Van Eps, Johnson) Department of Nephrology, University of Queensland, Princess Alexandra Hospital, Brisbane, Australia (Brown) Department of Nephrology, Monash Medical Centre, Melbourne, Australia (Hawley, Johnson) Australasian Kidney Trials Network, School of Medicine, University of Queensland, Brisbane, Australia | Issue Date: | 4-Dec-2012 | Copyright year: | 2012 | Publisher: | Oxford University Press (Great Clarendon Street, Oxford OX2 6DP, United Kingdom) | Place of publication: | United Kingdom | Publication information: | Nephrology Dialysis Transplantation. 27 (11) (pp 4146-4153), 2012. Date of Publication: November 2012. | Abstract: | BackgroundPreliminary clinical evidence suggests that heme iron polypeptide (HIP) might represent a promising, novel oral iron supplementation strategy in chronic kidney disease. The aim of this multi-centre randomized controlled trial was to determine the ability of HIP administration to augment iron stores in darbepoetin (DPO)-treated patients compared with conventional oral iron supplementation.MethodsAdult peritoneal dialysis (PD) patients treated with DPO were randomized 1:1 to receive two capsules daily of either HIP or ferrous sulphate per os for 6 months. The primary outcome measure was transferrin saturation (TSAT). Secondary outcomes comprised serum ferritin, haemoglobin, DPO dose and responsiveness, and adverse events.ResultsSixty-two patients were randomized to HIP (n = 32) or ferrous sulphate (n = 30). On intention-to-treat analysis, the median (inter-quartile range) TSAT was 22 (16-29) in the HIP group compared with 20 (17-26) in controls (P = 0.65). HIP treatment was not significantly associated with TSAT at 6 months on multivariable analysis (P = 0.95). Similar results were found on per-protocol analysis and subgroup analysis in iron-deficient patients. Serum ferritin levels at 6 months were significantly lower in the HIP group (P = 0.003), while the cost of HIP was 7-fold higher than that of ferrous sulphate. No other differences in secondary outcomes were observed.ConclusionsHIP showed no clear safety or efficacy benefit in PD patients compared with conventional oral iron supplements. The reduction in serum ferritin levels and high costs associated with HIP therapy suggest that this agent is unlikely to have a significant role in iron supplementation in PD patients. © The Author 2012. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1093/ndt/gfs372 | PubMed URL: | 22962411 [http://www.ncbi.nlm.nih.gov/pubmed/?term=22962411] | ISSN: | 0931-0509 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/28181 | Type: | Article | Subjects: | dose response calcinosis/si [Side Effect] clinical protocol constipation/si [Side Effect] controlled study diarrhea/si [Side Effect] drug cost drug efficacy drug safety faintness/si [Side Effect] female ferritin blood level gastrointestinal symptom/si [Side Effect] heart arrest/si [Side Effect] heart infarction/si [Side Effect] hematological parameters *hemodialysis patient hemoglobin blood level human hypercalcemia/si [Side Effect] intention to treat analysis iron storage kidney failure/co [Complication] kidney failure/th [Therapy] liver cyst/si [Side Effect] major clinical study male multicenter study open study outcome assessment *peritoneal dialysis peritonitis/si [Side Effect] phase 4 clinical trial priority journal prospective study randomized controlled trial respiratory tract disease/si [Side Effect] restless legs syndrome/si [Side Effect] supplementation treatment duration ulcer/si [Side Effect] unspecified side effect/si [Side Effect] unstable angina pectoris/si [Side Effect] urinary tract disease/si [Side Effect] vomiting/si [Side Effect] weakness/si [Side Effect] ferritin/ec [Endogenous Compound] *ferrous sulfate/ae [Adverse Drug Reaction] *ferrous sulfate/ct [Clinical Trial] *ferrous sulfate/cm [Drug Comparison] *ferrous sulfate/dt [Drug Therapy] *ferrous sulfate/po [Oral Drug Administration] *ferrous sulfate/pr [Pharmaceutics] hemoglobin/ec [Endogenous Compound] *iron saccharate/ae [Adverse Drug Reaction] *iron saccharate/ct [Clinical Trial] *iron saccharate/cm [Drug Comparison] *iron saccharate/dt [Drug Therapy] *iron saccharate/po [Oral Drug Administration] *iron saccharate/pr [Pharmaceutics] novel erythropoiesis stimulating protein/dt [Drug Therapy] transferrin/ec [Endogenous Compound] unclassified drug transferrin saturation proferrin es abdominal pain/si [Side Effect] adult *anemia/co [Complication] *anemia/dm [Disease Management] *anemia/dt [Drug Therapy] anemia/dt [Drug Therapy] article ulcer / side effect urinary tract disease / side effect vomiting / side effect weakness / side effect constipation / side effect clinical protocol calcinosis / side effect article abdominal pain / side effect adult *anemia / *complication / *disease management / *drug therapy anemia / drug therapy controlled study diarrhea / side effect dose response drug cost drug efficacy drug safety faintness / side effect female ferritin blood level gastrointestinal symptom / side effect heart arrest / side effect heart infarction / side effect hematological parameters *hemodialysis patient hemoglobin blood level human hypercalcemia / side effect intention to treat analysis iron storage kidney failure / complication / therapy liver cyst / side effect major clinical study male multicenter study open study outcome assessment *peritoneal dialysis peritonitis / side effect phase 4 clinical trial priority journal prospective study randomized controlled trial respiratory tract disease / side effect restless legs syndrome / side effect supplementation treatment duration unspecified side effect / side effect unstable angina pectoris / side effect |
Type of Clinical Study or Trial: | Randomised controlled trial |
Appears in Collections: | Articles |
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