Hepcidin Response to Iron Therapy in Patients with Non-Dialysis Dependent CKD: An Analysis of the FIND-CKD Trial
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 chron...
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| creator | Gaillard, Carlo A Bock, Andreas H Carrera, Fernando Eckardt, Kai-Uwe Van Wyck, David B Bansal, Sukhvinder S Cronin, Maureen Meier, Yvonne Larroque, Sylvain Roger, Simon D Macdougall, Iain C |
| description | 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. Serum hepcidin levels were measured centrally in a subset of 61 patients. Mean (SD) baseline hepcidin level was 4.0(3.5), 7.3(6.4) and 6.5(5.6) ng/mL in the high ferritin FCM (n = 17), low ferritin FCM (n = 16) and oral iron group (n = 28). The mean (SD) endpoint value (i.e. the last post-baseline value) was 26.0(9.1),15.7(7.7) and 16.3(11.0) ng/mL, respectively. The increase in hepcidin from baseline was significantly smaller with low ferritin FCM or oral iron vs high ferritin FCM at all time points up to week 52. Significant correlations were found between absolute hepcidin and ferritin values (r = 0.65, p |
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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. Serum hepcidin levels were measured centrally in a subset of 61 patients. Mean (SD) baseline hepcidin level was 4.0(3.5), 7.3(6.4) and 6.5(5.6) ng/mL in the high ferritin FCM (n = 17), low ferritin FCM (n = 16) and oral iron group (n = 28). The mean (SD) endpoint value (i.e. the last post-baseline value) was 26.0(9.1),15.7(7.7) and 16.3(11.0) ng/mL, respectively. The increase in hepcidin from baseline was significantly smaller with low ferritin FCM or oral iron vs high ferritin FCM at all time points up to week 52. Significant correlations were found between absolute hepcidin and ferritin values (r = 0.65, p<0.001) and between final post-baseline increases in both parameters (r = 0.70, p<0.001). The increase in hepcidin levels over the 12-month study generally mirrored the cumulative iron dose in each group. Hepcidin and transferrin saturation (TSAT) absolute values showed no correlation, although there was an association between final post-baseline increases (r = 0.42, p<0.001). Absolute values (r = 0.36, p = 0.004) and final post-baseline increases of hepcidin and hemoglobin (p = 0.30, p = 0.030) correlated weakly. Baseline hepcidin levels were not predictive of a hematopoietic response to iron therapy. In conclusion, hepcidin levels rose in response to either intravenous or oral iron therapy, but the speed and extent of the rise was greatest with intravenous iron targeting a higher ferritin level. However neither the baseline level nor the change in hepcidin was able to predict response to therapy in this cohort.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0157063</identifier><identifier>PMID: 27276035</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Administration, Intravenous ; Aged ; Aged, 80 and over ; Analysis ; Anemia ; Anemia, Iron-Deficiency - blood ; Anemia, Iron-Deficiency - drug therapy ; Anemia, Iron-Deficiency - etiology ; Biology and Life Sciences ; Care and treatment ; Chronic kidney failure ; Correlation ; Dialysis ; Erythropoiesis ; Female ; Ferric Compounds - administration & dosage ; Ferritin ; Ferritins - blood ; Health aspects ; Hemoglobin ; Hepcidin ; Hepcidins - blood ; Homeostasis ; Humans ; Intravenous administration ; Iron ; Iron - administration & dosage ; Iron deficiency ; Kidney diseases ; Male ; Maltose - administration & dosage ; Maltose - analogs & derivatives ; Medicine and Health Sciences ; Middle Aged ; Nephrology ; Nutrient deficiency ; Patients ; Peritoneal dialysis ; Prospective Studies ; Randomization ; Renal Insufficiency, Chronic - blood ; Renal Insufficiency, Chronic - complications ; Renal Insufficiency, Chronic - drug therapy ; Studies ; Therapy ; Time Factors ; Transferrin ; Transferrins</subject><ispartof>PloS one, 2016-06, Vol.11 (6), p.e0157063-e0157063</ispartof><rights>COPYRIGHT 2016 Public Library of Science</rights><rights>2016 Gaillard et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2016 Gaillard et al 2016 Gaillard et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c686t-b8cdd1df5afda928e56116463e8364c3a9f25eb4719b0cac7c89ab4a9a234ffb3</citedby><cites>FETCH-LOGICAL-c686t-b8cdd1df5afda928e56116463e8364c3a9f25eb4719b0cac7c89ab4a9a234ffb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4898697/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4898697/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79569,79570</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27276035$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gaillard, Carlo A</creatorcontrib><creatorcontrib>Bock, Andreas H</creatorcontrib><creatorcontrib>Carrera, Fernando</creatorcontrib><creatorcontrib>Eckardt, Kai-Uwe</creatorcontrib><creatorcontrib>Van Wyck, David B</creatorcontrib><creatorcontrib>Bansal, Sukhvinder S</creatorcontrib><creatorcontrib>Cronin, Maureen</creatorcontrib><creatorcontrib>Meier, Yvonne</creatorcontrib><creatorcontrib>Larroque, Sylvain</creatorcontrib><creatorcontrib>Roger, Simon D</creatorcontrib><creatorcontrib>Macdougall, Iain C</creatorcontrib><title>Hepcidin Response to Iron Therapy in Patients with Non-Dialysis Dependent CKD: An Analysis of the FIND-CKD Trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>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. Serum hepcidin levels were measured centrally in a subset of 61 patients. Mean (SD) baseline hepcidin level was 4.0(3.5), 7.3(6.4) and 6.5(5.6) ng/mL in the high ferritin FCM (n = 17), low ferritin FCM (n = 16) and oral iron group (n = 28). The mean (SD) endpoint value (i.e. the last post-baseline value) was 26.0(9.1),15.7(7.7) and 16.3(11.0) ng/mL, respectively. The increase in hepcidin from baseline was significantly smaller with low ferritin FCM or oral iron vs high ferritin FCM at all time points up to week 52. Significant correlations were found between absolute hepcidin and ferritin values (r = 0.65, p<0.001) and between final post-baseline increases in both parameters (r = 0.70, p<0.001). The increase in hepcidin levels over the 12-month study generally mirrored the cumulative iron dose in each group. Hepcidin and transferrin saturation (TSAT) absolute values showed no correlation, although there was an association between final post-baseline increases (r = 0.42, p<0.001). Absolute values (r = 0.36, p = 0.004) and final post-baseline increases of hepcidin and hemoglobin (p = 0.30, p = 0.030) correlated weakly. Baseline hepcidin levels were not predictive of a hematopoietic response to iron therapy. In conclusion, hepcidin levels rose in response to either intravenous or oral iron therapy, but the speed and extent of the rise was greatest with intravenous iron targeting a higher ferritin level. However neither the baseline level nor the change in hepcidin was able to predict response to therapy in this cohort.</description><subject>Administration, Intravenous</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Analysis</subject><subject>Anemia</subject><subject>Anemia, Iron-Deficiency - blood</subject><subject>Anemia, Iron-Deficiency - drug therapy</subject><subject>Anemia, Iron-Deficiency - etiology</subject><subject>Biology and Life Sciences</subject><subject>Care and treatment</subject><subject>Chronic kidney failure</subject><subject>Correlation</subject><subject>Dialysis</subject><subject>Erythropoiesis</subject><subject>Female</subject><subject>Ferric Compounds - administration & dosage</subject><subject>Ferritin</subject><subject>Ferritins - blood</subject><subject>Health aspects</subject><subject>Hemoglobin</subject><subject>Hepcidin</subject><subject>Hepcidins - blood</subject><subject>Homeostasis</subject><subject>Humans</subject><subject>Intravenous administration</subject><subject>Iron</subject><subject>Iron - administration & dosage</subject><subject>Iron deficiency</subject><subject>Kidney diseases</subject><subject>Male</subject><subject>Maltose - administration & dosage</subject><subject>Maltose - analogs & derivatives</subject><subject>Medicine and Health Sciences</subject><subject>Middle Aged</subject><subject>Nephrology</subject><subject>Nutrient deficiency</subject><subject>Patients</subject><subject>Peritoneal dialysis</subject><subject>Prospective Studies</subject><subject>Randomization</subject><subject>Renal Insufficiency, Chronic - blood</subject><subject>Renal Insufficiency, Chronic - complications</subject><subject>Renal Insufficiency, Chronic - drug therapy</subject><subject>Studies</subject><subject>Therapy</subject><subject>Time Factors</subject><subject>Transferrin</subject><subject>Transferrins</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNqNk11v0zAUhiMEYmPwDxBYQkJwkRLHjj92gVS1jFVMGxqFW8tx7MZTGgc7AfrvcddsahESSJZs-X3Oe-xjnyR5DrMJRBS-u3GDb2Uz6VyrJxksaEbQg-QYcpSnJM_Qw731UfIkhJssKxAj5HFylNOckgwVx0l3rjtlK9uCax2iVdCgd2DhXQuWtfay24CofZa91W0fwE_b1-DStencymYTbABz3em2iiKYfZqfgmkbxyg5A_pag7PF5TyNIlj6GPQ0eWRkE_SzcT5Jvp59WM7O04urj4vZ9CJVhJE-LZmqKliZQppK8pzpgkBIMEGaIYIVktzkhS4xhbzMlFRUMS5LLLnMETamRCfJy51v17ggxmIFASnHLMc5hZFY7IjKyRvRebuWfiOctOJ2w_mVkL63qtHCwExTSU1RKYSV0gyW0YbRwkjO1a3X-zHbUK51pWI9vGwOTA-V1tZi5X4IzDgjnEaDN6OBd98HHXqxtkHpppGtdkM8N8sYzUnM-W-U8mLL0iyir_5A_16IkVrJeFfbGhePqLamYooLXJCcchSptweUcm2vf_UrOYQgFl-u_5-9-nbIvt5jay2bvg6uGXobf-MhiHeg8i4Er819eWEmti1xdzmxbQkxtkQMe7H_NPdBdz2AfgNWnAWO</recordid><startdate>20160608</startdate><enddate>20160608</enddate><creator>Gaillard, Carlo A</creator><creator>Bock, Andreas H</creator><creator>Carrera, Fernando</creator><creator>Eckardt, Kai-Uwe</creator><creator>Van Wyck, David B</creator><creator>Bansal, Sukhvinder S</creator><creator>Cronin, Maureen</creator><creator>Meier, Yvonne</creator><creator>Larroque, Sylvain</creator><creator>Roger, Simon D</creator><creator>Macdougall, Iain C</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20160608</creationdate><title>Hepcidin Response to Iron Therapy in Patients with Non-Dialysis Dependent CKD: An Analysis of the FIND-CKD Trial</title><author>Gaillard, Carlo A ; Bock, Andreas H ; Carrera, Fernando ; Eckardt, Kai-Uwe ; Van Wyck, David B ; Bansal, Sukhvinder S ; Cronin, Maureen ; Meier, Yvonne ; Larroque, Sylvain ; Roger, Simon D ; Macdougall, Iain C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c686t-b8cdd1df5afda928e56116463e8364c3a9f25eb4719b0cac7c89ab4a9a234ffb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administration, Intravenous</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Analysis</topic><topic>Anemia</topic><topic>Anemia, Iron-Deficiency - 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Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agriculture Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>ProQuest Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest advanced technologies & aerospace journals</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>Engineering collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gaillard, Carlo A</au><au>Bock, Andreas H</au><au>Carrera, Fernando</au><au>Eckardt, Kai-Uwe</au><au>Van Wyck, David B</au><au>Bansal, Sukhvinder S</au><au>Cronin, Maureen</au><au>Meier, Yvonne</au><au>Larroque, Sylvain</au><au>Roger, Simon D</au><au>Macdougall, Iain C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Hepcidin Response to Iron Therapy in Patients with Non-Dialysis Dependent CKD: An Analysis of the FIND-CKD Trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2016-06-08</date><risdate>2016</risdate><volume>11</volume><issue>6</issue><spage>e0157063</spage><epage>e0157063</epage><pages>e0157063-e0157063</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>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. Serum hepcidin levels were measured centrally in a subset of 61 patients. Mean (SD) baseline hepcidin level was 4.0(3.5), 7.3(6.4) and 6.5(5.6) ng/mL in the high ferritin FCM (n = 17), low ferritin FCM (n = 16) and oral iron group (n = 28). The mean (SD) endpoint value (i.e. the last post-baseline value) was 26.0(9.1),15.7(7.7) and 16.3(11.0) ng/mL, respectively. The increase in hepcidin from baseline was significantly smaller with low ferritin FCM or oral iron vs high ferritin FCM at all time points up to week 52. Significant correlations were found between absolute hepcidin and ferritin values (r = 0.65, p<0.001) and between final post-baseline increases in both parameters (r = 0.70, p<0.001). The increase in hepcidin levels over the 12-month study generally mirrored the cumulative iron dose in each group. Hepcidin and transferrin saturation (TSAT) absolute values showed no correlation, although there was an association between final post-baseline increases (r = 0.42, p<0.001). Absolute values (r = 0.36, p = 0.004) and final post-baseline increases of hepcidin and hemoglobin (p = 0.30, p = 0.030) correlated weakly. Baseline hepcidin levels were not predictive of a hematopoietic response to iron therapy. In conclusion, hepcidin levels rose in response to either intravenous or oral iron therapy, but the speed and extent of the rise was greatest with intravenous iron targeting a higher ferritin level. However neither the baseline level nor the change in hepcidin was able to predict response to therapy in this cohort.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>27276035</pmid><doi>10.1371/journal.pone.0157063</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2016-06, Vol.11 (6), p.e0157063-e0157063 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1794824271 |
| source | MEDLINE; Public Library of Science; DOAJ Directory of Open Access Journals; PubMed Central; Free Full-Text Journals in Chemistry; EZB Electronic Journals Library |
| subjects | Administration, Intravenous Aged Aged, 80 and over Analysis Anemia Anemia, Iron-Deficiency - blood Anemia, Iron-Deficiency - drug therapy Anemia, Iron-Deficiency - etiology Biology and Life Sciences Care and treatment Chronic kidney failure Correlation Dialysis Erythropoiesis Female Ferric Compounds - administration & dosage Ferritin Ferritins - blood Health aspects Hemoglobin Hepcidin Hepcidins - blood Homeostasis Humans Intravenous administration Iron Iron - administration & dosage Iron deficiency Kidney diseases Male Maltose - administration & dosage Maltose - analogs & derivatives Medicine and Health Sciences Middle Aged Nephrology Nutrient deficiency Patients Peritoneal dialysis Prospective Studies Randomization Renal Insufficiency, Chronic - blood Renal Insufficiency, Chronic - complications Renal Insufficiency, Chronic - drug therapy Studies Therapy Time Factors Transferrin Transferrins |
| title | Hepcidin Response to Iron Therapy in Patients with Non-Dialysis Dependent CKD: An Analysis of the FIND-CKD Trial |
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