Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study

Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluat...

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Published in:Clinical Kidney Journal 2021-07, Vol.14 (7), p.1770-1779
Main Authors: Vervloet, Marc G, Boletis, Ioannis N, de Francisco, Angel L M, Kalra, Philip A, Ketteler, Markus, Messa, Piergiorgio, Stauss-Grabo, Manuela, Derlet, Anja, Walpen, Sebastian, Perrin, Amandine, Ficociello, Linda H, Rottembourg, Jacques, Wanner, Christoph, Cannata-Andía, Jorge B, Fouque, Denis
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Language:English
Subjects:
Analysis
Care and treatment
Chronic kidney failure
Ferritin
Human health and pathology
Life Sciences
Medical research
Medicine, Experimental
Original
Patient compliance
Phosphates
Safety and security measures
Sevelamer carbonate
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container_end_page 1779
container_issue 7
container_start_page 1770
container_title Clinical Kidney Journal
container_volume 14
creator Vervloet, Marc G
Boletis, Ioannis N
de Francisco, Angel L M
Kalra, Philip A
Ketteler, Markus
Messa, Piergiorgio
Stauss-Grabo, Manuela
Derlet, Anja
Walpen, Sebastian
Perrin, Amandine
Ficociello, Linda H
Rottembourg, Jacques
Wanner, Christoph
Cannata-Andía, Jorge B
Fouque, Denis
description Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels. Results The safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: −1.0 mg/dL, P 
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Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels. Results The safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: −1.0 mg/dL, P &lt; 0.01). Percentage of patients achieving serum phosphorus ≤4.5 mg/dL increased from 12.0% at BL to 34.8% at Month 30, while the percentage achieving serum phosphorus ≤5.5 mg/dL increased from 29.9% to 63.0%. Conclusions SFOH has a favourable safety and tolerability profile in a real-world setting, consistent with results of the Phase 3 study. Moreover, SFOH improved serum phosphorus control with a low daily pill burden.</description><identifier>ISSN: 2048-8505</identifier><identifier>EISSN: 2048-8513</identifier><identifier>DOI: 10.1093/ckj/sfaa211</identifier><identifier>PMID: 34221384</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Analysis ; Care and treatment ; Chronic kidney failure ; Ferritin ; Human health and pathology ; Life Sciences ; Medical research ; Medicine, Experimental ; Original ; Patient compliance ; Phosphates ; Safety and security measures ; Sevelamer carbonate</subject><ispartof>Clinical Kidney Journal, 2021-07, Vol.14 (7), p.1770-1779</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA. 2021</rights><rights>The Author(s) 2021. Published by Oxford University Press on behalf of ERA-EDTA.</rights><rights>COPYRIGHT 2021 Oxford University Press</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c513t-8ae3e920dd23b43324ece748340fe3e076b382fa58c6e934a5c1df429d49ffb13</citedby><orcidid>0000-0003-4607-9415 ; 0000-0002-9707-7199 ; 0000-0002-1512-559X ; 0000-0001-9507-5301</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8243278/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8243278/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34221384$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.sorbonne-universite.fr/hal-03375115$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Vervloet, Marc G</creatorcontrib><creatorcontrib>Boletis, Ioannis N</creatorcontrib><creatorcontrib>de Francisco, Angel L M</creatorcontrib><creatorcontrib>Kalra, Philip A</creatorcontrib><creatorcontrib>Ketteler, Markus</creatorcontrib><creatorcontrib>Messa, Piergiorgio</creatorcontrib><creatorcontrib>Stauss-Grabo, Manuela</creatorcontrib><creatorcontrib>Derlet, Anja</creatorcontrib><creatorcontrib>Walpen, Sebastian</creatorcontrib><creatorcontrib>Perrin, Amandine</creatorcontrib><creatorcontrib>Ficociello, Linda H</creatorcontrib><creatorcontrib>Rottembourg, Jacques</creatorcontrib><creatorcontrib>Wanner, Christoph</creatorcontrib><creatorcontrib>Cannata-Andía, Jorge B</creatorcontrib><creatorcontrib>Fouque, Denis</creatorcontrib><title>Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study</title><title>Clinical Kidney Journal</title><addtitle>Clin Kidney J</addtitle><description>Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels. Results The safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: −1.0 mg/dL, P &lt; 0.01). Percentage of patients achieving serum phosphorus ≤4.5 mg/dL increased from 12.0% at BL to 34.8% at Month 30, while the percentage achieving serum phosphorus ≤5.5 mg/dL increased from 29.9% to 63.0%. Conclusions SFOH has a favourable safety and tolerability profile in a real-world setting, consistent with results of the Phase 3 study. 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Boletis, Ioannis N ; de Francisco, Angel L M ; Kalra, Philip A ; Ketteler, Markus ; Messa, Piergiorgio ; Stauss-Grabo, Manuela ; Derlet, Anja ; Walpen, Sebastian ; Perrin, Amandine ; Ficociello, Linda H ; Rottembourg, Jacques ; Wanner, Christoph ; Cannata-Andía, Jorge B ; Fouque, Denis</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c513t-8ae3e920dd23b43324ece748340fe3e076b382fa58c6e934a5c1df429d49ffb13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Analysis</topic><topic>Care and treatment</topic><topic>Chronic kidney failure</topic><topic>Ferritin</topic><topic>Human health and pathology</topic><topic>Life Sciences</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Original</topic><topic>Patient compliance</topic><topic>Phosphates</topic><topic>Safety and security measures</topic><topic>Sevelamer carbonate</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vervloet, Marc G</creatorcontrib><creatorcontrib>Boletis, Ioannis N</creatorcontrib><creatorcontrib>de Francisco, Angel L M</creatorcontrib><creatorcontrib>Kalra, Philip A</creatorcontrib><creatorcontrib>Ketteler, Markus</creatorcontrib><creatorcontrib>Messa, Piergiorgio</creatorcontrib><creatorcontrib>Stauss-Grabo, Manuela</creatorcontrib><creatorcontrib>Derlet, Anja</creatorcontrib><creatorcontrib>Walpen, Sebastian</creatorcontrib><creatorcontrib>Perrin, Amandine</creatorcontrib><creatorcontrib>Ficociello, Linda H</creatorcontrib><creatorcontrib>Rottembourg, Jacques</creatorcontrib><creatorcontrib>Wanner, Christoph</creatorcontrib><creatorcontrib>Cannata-Andía, Jorge B</creatorcontrib><creatorcontrib>Fouque, Denis</creatorcontrib><collection>Oxford University Press Journals Open Access</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Clinical Kidney Journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vervloet, Marc G</au><au>Boletis, Ioannis N</au><au>de Francisco, Angel L M</au><au>Kalra, Philip A</au><au>Ketteler, Markus</au><au>Messa, Piergiorgio</au><au>Stauss-Grabo, Manuela</au><au>Derlet, Anja</au><au>Walpen, Sebastian</au><au>Perrin, Amandine</au><au>Ficociello, Linda H</au><au>Rottembourg, Jacques</au><au>Wanner, Christoph</au><au>Cannata-Andía, Jorge B</au><au>Fouque, Denis</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study</atitle><jtitle>Clinical Kidney Journal</jtitle><addtitle>Clin Kidney J</addtitle><date>2021-07-01</date><risdate>2021</risdate><volume>14</volume><issue>7</issue><spage>1770</spage><epage>1779</epage><pages>1770-1779</pages><issn>2048-8505</issn><eissn>2048-8513</eissn><abstract>Background The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), is indicated to control serum phosphorus levels in patients with chronic kidney disease on dialysis. Methods This non-interventional, prospective, multicentre, cohort study conducted in seven European countries evaluated the safety and effectiveness of SFOH in dialysis patients with hyperphosphataemia in routine practice. Safety outcomes included adverse drug reactions (ADRs) and changes in iron-related parameters. SFOH effectiveness was evaluated by changes-from-baseline (BL) in serum phosphorus and percentage of patients achieving in-target phosphorus levels. Results The safety analysis set included 1365 patients (mean observation: 420.3 ± 239.3 days). Overall, 682 (50.0%) patients discontinued the study. Mean SFOH dose during the observation period was 1172.7 ± 539.9 mg (2.3 pills/day). Overall, 617 (45.2%) patients received concomitant PB(s) during SFOH treatment. ADRs and serious ADRs were observed for 531 (38.9%) and 26 (1.9%) patients. Most frequent ADRs were diarrhoea (194 patients, 14.2%) and discoloured faeces (128 patients, 9.4%). Diarrhoea generally occurred early during SFOH treatment and was mostly mild and transient. Small increases from BL in serum ferritin were observed (ranging from +12 to +75 µg/L). SFOH treatment was associated with serum phosphorus reductions (6.3 ± 1.6 mg/dL at BL versus 5.3 ± 1.8 mg/dL at Month 30; ΔBL: −1.0 mg/dL, P &lt; 0.01). Percentage of patients achieving serum phosphorus ≤4.5 mg/dL increased from 12.0% at BL to 34.8% at Month 30, while the percentage achieving serum phosphorus ≤5.5 mg/dL increased from 29.9% to 63.0%. Conclusions SFOH has a favourable safety and tolerability profile in a real-world setting, consistent with results of the Phase 3 study. Moreover, SFOH improved serum phosphorus control with a low daily pill burden.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>34221384</pmid><doi>10.1093/ckj/sfaa211</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-4607-9415</orcidid><orcidid>https://orcid.org/0000-0002-9707-7199</orcidid><orcidid>https://orcid.org/0000-0002-1512-559X</orcidid><orcidid>https://orcid.org/0000-0001-9507-5301</orcidid><oa>free_for_read</oa></addata></record>
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subjects Analysis
Care and treatment
Chronic kidney failure
Ferritin
Human health and pathology
Life Sciences
Medical research
Medicine, Experimental
Original
Patient compliance
Phosphates
Safety and security measures
Sevelamer carbonate
title Real-world safety and effectiveness of sucroferric oxyhydroxide for treatment of hyperphosphataemia in dialysis patients: a prospective observational study
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