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Intravenous Iron in non dialysis patients

Wieneke M Michels, Bernard G Jaar, Patti L Ephraim, Yang Liu, Dana C Miskulin, Navdeep Tangri, Deidra C Crews, Julia J Scialla, Tariq Shafi, Stephen M Sozio, Karen Bandeen-Roche, Courtney J Cook, Klemens B Meyer, L Ebony Boulware
BACKGROUND: The effect of maintenance intravenous (IV) iron administration on subsequent achievement of anemia management goals and mortality among patients recently initiating hemodialysis is unclear. METHODS: We performed an observational cohort study, in adult incident dialysis patients starting on hemodialysis. We defined IV administration strategies over a 12-week period following a patient's initiation of hemodialysis; all those receiving IV iron at regular intervals were considered maintenance, and all others were considered non-maintenance...
September 6, 2016: Nephrology, Dialysis, Transplantation
Adrian C Covic, Jürgen Floege, Markus Ketteler, Stuart M Sprague, Laura Lisk, Viatcheslav Rakov, Anjay Rastogi
BACKGROUND: Sucroferric oxyhydroxide is a non-calcium, iron-based phosphate binder indicated for the treatment of hyperphosphataemia in adult dialysis patients. This post hoc analysis of a randomized, 24-week Phase 3 study and its 28-week extension was performed to evaluate the long-term effect of sucroferric oxyhydroxide on iron parameters. METHODS: A total of 1059 patients were randomized to sucroferric oxyhydroxide 1.0-3.0 g/day (n = 710) or sevelamer carbonate ('sevelamer') 2...
June 23, 2016: Nephrology, Dialysis, Transplantation
Carlo A Gaillard, Andreas H Bock, Fernando Carrera, Kai-Uwe Eckardt, David B Van Wyck, Sukhvinder S Bansal, Maureen Cronin, Yvonne Meier, Sylvain Larroque, Simon D Roger, Iain C Macdougall
Hepcidin is the key regulator of iron homeostasis but data are limited regarding its temporal response to iron therapy, and response to intravenous versus oral iron. In the 56-week, open-label, multicenter, prospective, randomized FIND-CKD study, 626 anemic patients with non-dialysis dependent chronic kidney disease (ND-CKD) and iron deficiency not receiving an erythropoiesis stimulating agent were randomized (1:1:2) to intravenous ferric carboxymaltose (FCM), targeting higher (400-600μg/L) or lower (100-200μg/L) ferritin, or to oral iron...
2016: PloS One
Geoffrey A Block
Ferric citrate (FC) is an iron-containing phosphate binder that has been shown to effectively decrease serum phosphate, increase hemoglobin, and replete iron stores in patients with chronic kidney disease. Intestinal absorption of iron from FC results in increases in serum iron, ferritin, and transferrin saturation, effects that occur over 12 to 24 weeks and subsequently appear to plateau. As a result, use of erythropoiesis-stimulating agents and intravenous iron is reduced significantly and in clinical trials in patients receiving hemodialysis, the majority of subjects were able to discontinue intravenous iron use completely...
March 2016: Seminars in Nephrology
Guy Rostoker, Nosratola D Vaziri, Steven Fishbane
Iron overload used to be considered rare in hemodialysis patients but its clinical frequency is now increasingly realized. The liver is the main site of iron storage and the liver iron concentration (LIC) is closely correlated with total iron stores in patients with secondary hemosideroses and genetic hemochromatosis. Magnetic resonance imaging is now the gold standard method for LIC estimation and monitoring in non-renal patients. Studies of LIC in hemodialysis patients by quantitative magnetic resonance imaging and magnetic susceptometry have demonstrated a strong relation between the risk of iron overload and the use of intravenous (IV) iron products prescribed at doses determined by the iron biomarker cutoffs contained in current anemia management guidelines...
May 2016: Drugs
Jacques Rottembourg, Guy Rostoker
Iron deficiency is an important clinical concern in chronic kidney disease (CKD), giving rise to iron-deficiency anaemia, and various impaired cellular functions. Oral supplementation, in particular with ferrous salts, is associated with a high rate of gastro-intestinal side effects and is poorly absorbed, a problem that is avoided with intravenous (IV) irons. Recently, with the approval of the European Medicines Agency's Committee for Medicinal Products for Human Use, the French Agence nationale de sécurité du médicament et des produits de santé (ANSM) took adequate measures to minimize the risk of allergic reactions, by correction on the summary of intravenous iron products characteristics...
December 2015: Néphrologie & Thérapeutique
Philip A Kalra, Sunil Bhandari, Sanjiv Saxena, Dhananjai Agarwal, Georg Wirtz, Josef Kletzmayr, Lars L Thomsen, Daniel W Coyne
BACKGROUND: Iron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia. METHODS: The trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B)...
April 2016: Nephrology, Dialysis, Transplantation
A Syed, S Bhandari
BACKGROUND: Intravenous (IV) iron is commonly used for correcting iron deficiency anaemia in patients with chronic kidney disease (CKD). There remains a concern for its use in patients with asthma as it may trigger an acute exacerbation. Pre-treatment with a single dose of parenteral hydrocortisone may obviate this risk. METHOD: We carried out a prospective study of known asthmatic patients with CKD requiring single-dose iron repletion therapy. We analysed the efficacy and safety of IV CosmoFer (low molecular weight iron dextran)...
March 2016: QJM: Monthly Journal of the Association of Physicians
Jorge Eduardo Toblli, Federico Di Gennaro
BACKGROUND: Patients with non-dialysis-dependent chronic kidney disease (ND-CKD) often receive an erythropoiesis-stimulating agent (ESA) and oral iron treatment. This study evaluated whether a switch from oral iron to intravenous ferric carboxymaltose can reduce ESA requirements and improve iron status and hemoglobin in patients with ND-CKD. METHODS: This prospective, single arm and single-center study included adult patients with ND-CKD (creatinine clearance ≤40 mL/min), hemoglobin 11-12 g/dL and iron deficiency (ferritin <100 μg/L or transferrin saturation <20%), who were regularly treated with oral iron and ESA during 6 months prior to inclusion...
2015: PloS One
Bergur Stefansson
The main causes for renal anemia are insufficient erythropoietin production and absolute and/or functional iron deficiency. Absolute iron deficiency occurs with blood losses (most common are gastro-intestinal bleedings and hemodialysis treatments) or inadequate iron absorption in the gut (mainly due to increased circulating hepcidin or treatment with erythropoiesis stimulating agents). The explanation for functional iron deficiency is the high level of circulating hepcidin found in chronic kidney disease patients...
2015: Läkartidningen
Jorge Eduardo Toblli, Margarita Angerosa
With the challenge of optimizing iron delivery, new intravenous (iv) iron-carbohydrate complexes have been developed in the last few years. A good example of these new compounds is ferric carboxymaltose (FCM), which has recently been approved by the US Food and Drug Administration for the treatment of iron deficiency anemia in adult patients who are intolerant to oral iron or present an unsatisfactory response to oral iron, and in adult patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). FCM is a robust and stable complex similar to ferritin, which minimizes the release of labile iron during administration, allowing higher doses to be administered in a single application and with a favorable cost-effective rate...
2014: Drug Design, Development and Therapy
Emanuel Zitt, Gisela Sturm, Florian Kronenberg, Ulrich Neyer, Florian Knoll, Karl Lhotta, Günter Weiss
BACKGROUND: Studies on the association between iron supplementation and mortality in dialysis patients are rare and conflicting. METHODS: In our observational single-center cohort study (INVOR study) we prospectively studied 235 incident dialysis patients. Time-dependent Cox proportional hazards models using all measured laboratory values for up to 7.6 years were applied to study the association between iron supplementation and all-cause mortality, cardiovascular and sepsis-related mortality...
2014: PloS One
Antonio Pisani, Eleonora Riccio, Massimo Sabbatini, Michele Andreucci, Antonio Del Rio, Bianca Visciano
INTRODUCTION: Iron deficiency is a common cause of anaemia in non-dialysis chronic kidney disease (ND-CKD). Controversies exist about the optimal route of administration for iron therapy. Liposomal iron, a new generation oral iron with high gastrointestinal absorption and bioavailability and a low incidence of side effects, seems to be a promising new strategy of iron replacement. Therefore, we conducted a study to determine whether liposomal iron, compared with intravenous (IV) iron, improves anaemia in ND-CKD patients...
April 2015: Nephrology, Dialysis, Transplantation
Szu-Chun Hung, Ko-Lin Kuo, Der-Cherng Tarng, Chih-Cheng Hsu, Mai-Szu Wu, Tung-Po Huang
The introduction of erythropoiesis-stimulating agents (ESAs) markedly improved the lives of many anaemic patients with chronic kidney disease (CKD). In Taiwan, the strategy of management of anaemia in patients with CKD was different from many other parts of the world. In 1996, the National Health Insurance Administration of Taiwan applied a more restrictive reimbursement criteria for ESA use in patients with CKD. ESA is to be initiated when non-dialysis CKD patients have a serum creatinine >6 mg/dL and a hematocrit <28% to maintain a hematocrit level not exceeding 30%...
December 2014: Nephrology
Lenar Yessayan, Jerry Yee, Gary Zasuwa, Stan Frinak, Anatole Besarab
BACKGROUND: Iron deficiency is common in non-dialysis chronic kidney disease (ND-CKD) patients and, on occasion, requires parenteral iron therapy. We investigated the effect of intravenous iron repletion on platelet counts in ND-CKD patients with and without concomitant darbepoetin administration. METHODS: We conducted a retrospective analysis of ND-CKD patients with iron deficiency anemia treated with low molecular weight iron dextran (LMWID) between 2005 and 2009 at our CKD clinic...
2014: BMC Nephrology
Scott P Sibbel, Linda H Ficociello, Michael Black, Mayuri Thakuria, Claudy Mullon, Jose Diaz-Buxo, Thomas J Alfieri
BACKGROUND: The Crit-Line® monitor (CLM) is a device for monitoring hematocrit, oxygen saturation and change in intravascular blood volume during hemodialysis. Prior studies have evaluated CLM use in dialysis patients, but not specifically in those new to dialysis. METHODS: In this retrospective analysis, 199 patients initiating dialysis at 8 facilities routinely using CLM were compared with 796 propensity score-matched non-CLM patients initiating dialysis at facilities not using CLM...
2014: Blood Purification
Iain C Macdougall, Andreas H Bock, Fernando Carrera, Kai-Uwe Eckardt, Carlo Gaillard, David Van Wyck, Bernard Roubert, Jacqueline G Nolen, Simon D Roger
BACKGROUND: The optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown. METHODS: Ferinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400-600 µg/L) or lower (100-200 µg/L) ferritin or oral iron therapy...
November 2014: Nephrology, Dialysis, Transplantation
Mercedes Prats, Ramon Font, Carmen García, Mònica Muñoz-Cortés, Carmen Cabré, Manel Jariod, Marta Romeu, Montserrat Giralt, Alberto Martinez-Vea
BACKGROUND: Nearly half of all non-dialysis chronic kidney disease (CKD) patients respond to iron therapy. Factors affecting anemia response to iron therapy are not well characterized. Oxidative stress (OS) is a recognized factor for anemia in CKD and promotes erythropoiesis stimulating agent (ESA) resistance; however, the influence in predicting response to intravenous (IV) iron has not been evaluated. METHODS: Patients (n = 47) with non-dialysis CKD stages 3 - 5 (mean eGFR: 26 ± 10...
June 2014: Clinical Nephrology
Sourabh Chand, Douglas G Ward, Zhi-Yan Valerie Ng, James Hodson, Heidi Kirby, Patricia Steele, Irina Rooplal, Ferly Bantugon, Tariq Iqbal, Chris Tselepis, Mark T Drayson, Alison Whitelegg, Marie Chowrimootoo, Richard Borrows
BACKGROUND: Hepcidin-25 is an iron regulator which reduces iron absorption and promotes sequestration in the reticulo-endothelial system. We investigated hepcidin and traditional iron storage marker utility in predicting haemoglobin increment following bolus intravenous iron. METHODS: The cohort included 129 consecutive non-dialysis chronic kidney disease patients that attended for intravenous iron over a 6-month period. Serum hepcidin-25 levels (determined by mass spectrometry) pre iron infusion and 6 weeks post were compared with ferritin and transferrin saturation in multivariate models...
February 2015: Journal of Nephrology
Nosratola D Vaziri
Loss of blood associated with hemodialysis procedures and laboratory testing, together with impaired iron absorption due to elevation of hepcidin, invariably cause iron deficiency in end-stage renal disease patients. For this reason, nearly all ESRD patients require intravenous iron to replete iron stores. Unfortunately, intravenously administered iron is often used routinely with inadequate attention to the body iron stores or severity of systemic inflammation. This has led to an epidemic of iron overload in the ESRD population...
February 2014: Nephrology News & Issues
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