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Effects of sucroferric oxyhydroxide and sevelamer carbonate on chronic kidney disease–mineral bone disorder parameters in dialysis patients
Abstract Background Treatment of hyperphosphataemia is the primary goal of chronic kidney disease–mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders sucroferric oxyhydroxide or sev...
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| Published in: | Nephrology, dialysis, transplantation dialysis, transplantation, 2019-07, Vol.34 (7), p.1163-1170 |
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| container_title | Nephrology, dialysis, transplantation |
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| creator | Ketteler, Markus Sprague, Stuart M Covic, Adrian C Rastogi, Anjay Spinowitz, Bruce Rakov, Viatcheslav Walpen, Sebastian Floege, Jürgen |
| description | Abstract
Background
Treatment of hyperphosphataemia is the primary goal of chronic kidney disease–mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders sucroferric oxyhydroxide or sevelamer carbonate (‘sevelamer’) on CKD-MBD indices among dialysis patients with hyperphosphataemia.
Methods
After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to sucroferric oxyhydroxide 1.0–3.0 g/day (n = 710) or sevelamer 2.4–14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis.
Results
Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P |
| doi_str_mv | 10.1093/ndt/gfy127 |
| format | article |
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Background
Treatment of hyperphosphataemia is the primary goal of chronic kidney disease–mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders sucroferric oxyhydroxide or sevelamer carbonate (‘sevelamer’) on CKD-MBD indices among dialysis patients with hyperphosphataemia.
Methods
After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to sucroferric oxyhydroxide 1.0–3.0 g/day (n = 710) or sevelamer 2.4–14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis.
Results
Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment.
Conclusions
Overall, 1 year of sucroferric oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.</description><identifier>ISSN: 0931-0509</identifier><identifier>EISSN: 1460-2385</identifier><identifier>DOI: 10.1093/ndt/gfy127</identifier><identifier>PMID: 29846719</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Chelating Agents - therapeutic use ; Chronic Kidney Disease-Mineral and Bone Disorder - complications ; Chronic Kidney Disease-Mineral and Bone Disorder - metabolism ; Chronic Kidney Disease-Mineral and Bone Disorder - therapy ; Drug Combinations ; Female ; Ferric Compounds - therapeutic use ; Follow-Up Studies ; Humans ; Hyperphosphatemia - drug therapy ; Hyperphosphatemia - etiology ; Male ; Middle Aged ; ORIGINAL ARTICLES ; Parathyroid Hormone - blood ; Phosphorus - blood ; Renal Dialysis ; Sevelamer - therapeutic use ; Sucrose - therapeutic use ; Time Factors ; Treatment Outcome</subject><ispartof>Nephrology, dialysis, transplantation, 2019-07, Vol.34 (7), p.1163-1170</ispartof><rights>The Author(s) 2018. Published by Oxford University Press on behalf of ERA-EDTA. 2018</rights><rights>The Author(s) 2018. Published by Oxford University Press on behalf of ERA-EDTA.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c408t-23890f9025a50a100d026a08f6afdb89fcffd2ce5896582c42fdd31d848740d23</citedby><cites>FETCH-LOGICAL-c408t-23890f9025a50a100d026a08f6afdb89fcffd2ce5896582c42fdd31d848740d23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29846719$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ketteler, Markus</creatorcontrib><creatorcontrib>Sprague, Stuart M</creatorcontrib><creatorcontrib>Covic, Adrian C</creatorcontrib><creatorcontrib>Rastogi, Anjay</creatorcontrib><creatorcontrib>Spinowitz, Bruce</creatorcontrib><creatorcontrib>Rakov, Viatcheslav</creatorcontrib><creatorcontrib>Walpen, Sebastian</creatorcontrib><creatorcontrib>Floege, Jürgen</creatorcontrib><title>Effects of sucroferric oxyhydroxide and sevelamer carbonate on chronic kidney disease–mineral bone disorder parameters in dialysis patients</title><title>Nephrology, dialysis, transplantation</title><addtitle>Nephrol Dial Transplant</addtitle><description>Abstract
Background
Treatment of hyperphosphataemia is the primary goal of chronic kidney disease–mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders sucroferric oxyhydroxide or sevelamer carbonate (‘sevelamer’) on CKD-MBD indices among dialysis patients with hyperphosphataemia.
Methods
After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to sucroferric oxyhydroxide 1.0–3.0 g/day (n = 710) or sevelamer 2.4–14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis.
Results
Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment.
Conclusions
Overall, 1 year of sucroferric oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.</description><subject>Chelating Agents - therapeutic use</subject><subject>Chronic Kidney Disease-Mineral and Bone Disorder - complications</subject><subject>Chronic Kidney Disease-Mineral and Bone Disorder - metabolism</subject><subject>Chronic Kidney Disease-Mineral and Bone Disorder - therapy</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Ferric Compounds - therapeutic use</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Hyperphosphatemia - drug therapy</subject><subject>Hyperphosphatemia - etiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>ORIGINAL ARTICLES</subject><subject>Parathyroid Hormone - blood</subject><subject>Phosphorus - blood</subject><subject>Renal Dialysis</subject><subject>Sevelamer - therapeutic use</subject><subject>Sucrose - therapeutic use</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0931-0509</issn><issn>1460-2385</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNp9kc9KXTEQxkOp1Fvtpg9QsimIcHWS8y_ZFES0LQhudB1yk4k37TnJbXKOeHZ9ga76hj6JuVwr7aargW9-880kHyHvGZwwkNVpsOPpnZsZ716RBatbWPJKNK_JojTZEhqQ--Rtzt8AQPKue0P2uRR12zG5IL8unEMzZhodzZNJ0WFK3tD4MK9nm-KDt0h1sDTjPfZ6wESNTqsY9Ig0BmrWKYbCf_c24Eytz6gzPv78PfiASfe0oLiVY7JldqNT8RgxZepDkXU_Z5-LPHoMYz4ke073Gd891wNye3lxc_5leXX9-ev52dXS1CDG7fMkOAm80Q1oBmCBtxqEa7WzKyGdcc5yg42QbSO4qbmztmJW1KKrwfLqgHza-W6m1YDWlN3lVrVJftBpVlF79W8n-LW6i_eqbaGqZFMMjp4NUvwxYR7V4LPBvtcB45QVh7rjjRSiKujxDi2fm3NC97KGgdrmp0p-apdfgT_8fdgL-iewAnzcAXHa_M_oCcT-qjE</recordid><startdate>20190701</startdate><enddate>20190701</enddate><creator>Ketteler, Markus</creator><creator>Sprague, Stuart M</creator><creator>Covic, Adrian C</creator><creator>Rastogi, Anjay</creator><creator>Spinowitz, Bruce</creator><creator>Rakov, Viatcheslav</creator><creator>Walpen, Sebastian</creator><creator>Floege, Jürgen</creator><general>Oxford University Press</general><scope>TOX</scope><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>7X8</scope><scope>5PM</scope></search><sort><creationdate>20190701</creationdate><title>Effects of sucroferric oxyhydroxide and sevelamer carbonate on chronic kidney disease–mineral bone disorder parameters in dialysis patients</title><author>Ketteler, Markus ; Sprague, Stuart M ; Covic, Adrian C ; Rastogi, Anjay ; Spinowitz, Bruce ; Rakov, Viatcheslav ; Walpen, Sebastian ; Floege, Jürgen</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c408t-23890f9025a50a100d026a08f6afdb89fcffd2ce5896582c42fdd31d848740d23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Chelating Agents - therapeutic use</topic><topic>Chronic Kidney Disease-Mineral and Bone Disorder - complications</topic><topic>Chronic Kidney Disease-Mineral and Bone Disorder - metabolism</topic><topic>Chronic Kidney Disease-Mineral and Bone Disorder - therapy</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Ferric Compounds - therapeutic use</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Hyperphosphatemia - drug therapy</topic><topic>Hyperphosphatemia - etiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>ORIGINAL ARTICLES</topic><topic>Parathyroid Hormone - blood</topic><topic>Phosphorus - blood</topic><topic>Renal Dialysis</topic><topic>Sevelamer - therapeutic use</topic><topic>Sucrose - therapeutic use</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ketteler, Markus</creatorcontrib><creatorcontrib>Sprague, Stuart M</creatorcontrib><creatorcontrib>Covic, Adrian C</creatorcontrib><creatorcontrib>Rastogi, Anjay</creatorcontrib><creatorcontrib>Spinowitz, Bruce</creatorcontrib><creatorcontrib>Rakov, Viatcheslav</creatorcontrib><creatorcontrib>Walpen, Sebastian</creatorcontrib><creatorcontrib>Floege, Jürgen</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Nephrology, dialysis, transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ketteler, Markus</au><au>Sprague, Stuart M</au><au>Covic, Adrian C</au><au>Rastogi, Anjay</au><au>Spinowitz, Bruce</au><au>Rakov, Viatcheslav</au><au>Walpen, Sebastian</au><au>Floege, Jürgen</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of sucroferric oxyhydroxide and sevelamer carbonate on chronic kidney disease–mineral bone disorder parameters in dialysis patients</atitle><jtitle>Nephrology, dialysis, transplantation</jtitle><addtitle>Nephrol Dial Transplant</addtitle><date>2019-07-01</date><risdate>2019</risdate><volume>34</volume><issue>7</issue><spage>1163</spage><epage>1170</epage><pages>1163-1170</pages><issn>0931-0509</issn><eissn>1460-2385</eissn><abstract>Abstract
Background
Treatment of hyperphosphataemia is the primary goal of chronic kidney disease–mineral and bone disorder (CKD-MBD) management. This post hoc analysis of a randomized, Phase 3 study evaluated the effects of 1-year treatment with the phosphate binders sucroferric oxyhydroxide or sevelamer carbonate (‘sevelamer’) on CKD-MBD indices among dialysis patients with hyperphosphataemia.
Methods
After a 2- to 4-week washout from previous phosphate binders, 1059 patients were randomized 2:1 to sucroferric oxyhydroxide 1.0–3.0 g/day (n = 710) or sevelamer 2.4–14.4 g/day (n = 349) for up to 24 weeks. Eligible patients enrolled in a 28-week extension. This post hoc analysis was performed for patients who completed ≥1 year of continuous treatment (n = 549). As the treatment groups showed similar CKD-MBD outcomes, the data were pooled for this analysis.
Results
Phosphate-binder therapy was associated with significant and sustained 30% reductions in serum phosphorus (P < 0.001). Median intact fibroblast growth factor-23 (FGF-23) also significantly decreased (P < 0.001) by 64% over 1 year. Intact parathyroid hormone decreased significantly after 24 weeks (P < 0.001), but levels returned to near baseline values by Week 52; minimal changes in serum calcium were observed. Of the bone resorption markers evaluated, tartrate-resistant acid phosphatase 5b (TRAP5b) decreased significantly (P < 0.001), whereas CTx increased transiently but returned to baseline levels by Week 52. The bone formation markers bone-specific alkaline phosphatase and osteocalcin both increased over 1 year of treatment.
Conclusions
Overall, 1 year of sucroferric oxyhydroxide or sevelamer treatment significantly reduced serum FGF-23, which has been associated with clinical benefit in patients with CKD. The trend towards increased bone formation marker levels indicates a beneficial effect on bone metabolism.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>29846719</pmid><doi>10.1093/ndt/gfy127</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Nephrology, dialysis, transplantation, 2019-07, Vol.34 (7), p.1163-1170 |
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| source | Oxford Journals Online |
| subjects | Chelating Agents - therapeutic use Chronic Kidney Disease-Mineral and Bone Disorder - complications Chronic Kidney Disease-Mineral and Bone Disorder - metabolism Chronic Kidney Disease-Mineral and Bone Disorder - therapy Drug Combinations Female Ferric Compounds - therapeutic use Follow-Up Studies Humans Hyperphosphatemia - drug therapy Hyperphosphatemia - etiology Male Middle Aged ORIGINAL ARTICLES Parathyroid Hormone - blood Phosphorus - blood Renal Dialysis Sevelamer - therapeutic use Sucrose - therapeutic use Time Factors Treatment Outcome |
| title | Effects of sucroferric oxyhydroxide and sevelamer carbonate on chronic kidney disease–mineral bone disorder parameters in dialysis patients |
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