Efficacy and Safety of Early Cyclosporine Conversion to Sirolimus with Continued MMF—Four‐Year Results of the Postconcept Study
Calcineurin inhibitor (CNI) withdrawal has been used as a strategy to improve renal allograft function. We previously reported that conversion from cyclosporine A (CsA) to sirolimus (SRL) 3 months after transplantation significantly improved renal function at 1 year. In the Postconcept trial, 77 pat...
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| Veröffentlicht in: | American journal of transplantation 2011-08, Vol.11 (8), p.1665-1675 |
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| creator | Lebranchu, Y. Thierry, A. Thervet, E. Büchler, M. Etienne, I. Westeel, P. F. de Ligny, B. Hurault Moulin, B. Rérolle, J. P. Frouget, T. Girardot‐Seguin, S. Toupance, O. |
| description | Calcineurin inhibitor (CNI) withdrawal has been used as a strategy to improve renal allograft function. We previously reported that conversion from cyclosporine A (CsA) to sirolimus (SRL) 3 months after transplantation significantly improved renal function at 1 year. In the Postconcept trial, 77 patients in the SRL group and 85 in the CsA group were followed for 48 months. Renal function (Cockcroft and Gault) was significantly better at month 48 (M48) in the SRL group both in the intent‐to‐treat population (ITT): 62.6 mL/min/1.73 m2 versus 57.1 mL/min/1.73 m2 (p = 0.013) and in the on‐treatment population (OT): 67.5 mL/min/1.73 m2 versus 57.4 mL/min/1.73 m2 (p = 0.002). Two biopsy proven acute rejection episodes occurred after M12 in each group. Graft and patient survival were comparable (graft survival: 97.4 vs. 100%; patient survival: 97.4 vs. 97.6%, respectively). The incidence of new‐onset diabetes was numerically increased in the SRL group (7 vs. 2). In OT, three cancers occurred in the SRL group versus nine in the CsA group and mean proteinuria was increased in the SRL group (0.42 ± 0.44 vs. 0.26 ± 0.37; p = 0.018). In summary, the renal benefits associated with conversion of CsA to SRL, at 3 months posttransplantation, in combination with MMF were maintained for 4 years posttransplantation.
A randomized study of an early cyclosporine to sirolimus conversion at 3 months after transplantation (the CONCEPT study) shows that the renal benefit observed at 1 year is maintained and even more pronounced at 4 years. |
| doi_str_mv | 10.1111/j.1600-6143.2011.03637.x |
| format | Article |
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A randomized study of an early cyclosporine to sirolimus conversion at 3 months after transplantation (the CONCEPT study) shows that the renal benefit observed at 1 year is maintained and even more pronounced at 4 years.</description><identifier>ISSN: 1600-6135</identifier><identifier>EISSN: 1600-6143</identifier><identifier>DOI: 10.1111/j.1600-6143.2011.03637.x</identifier><identifier>PMID: 21797975</identifier><language>eng</language><publisher>Malden, USA: Blackwell Publishing Inc</publisher><subject>Adult ; Biological and medical sciences ; Chronic allograft nephropathy ; CsA ; Cyclosporine ; Cyclosporine - adverse effects ; Cyclosporine - pharmacology ; Cyclosporine - therapeutic use ; Female ; Graft Survival ; Humans ; Immunosuppressive Agents ; Immunosuppressive Agents - adverse effects ; Immunosuppressive Agents - pharmacology ; Immunosuppressive Agents - therapeutic use ; Kidney Failure, Chronic ; Kidney Failure, Chronic - drug therapy ; Kidney Failure, Chronic - physiopathology ; Kidney Failure, Chronic - surgery ; Kidney Function Tests ; Kidney Transplantation ; Life Sciences ; Male ; Medical sciences ; Middle Aged ; Miscellaneous ; MMF ; Nephrology. Urinary tract diseases ; Nephropathies. Renovascular diseases. Renal failure ; nephrotoxicity ; Pharmaceutical sciences ; Public health. Hygiene ; Public health. Hygiene-occupational medicine ; Renal failure ; renal function ; renal transplantation ; Sirolimus ; Sirolimus - adverse effects ; Sirolimus - pharmacology ; Sirolimus - therapeutic use ; SRL conversion ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Surgery of the urinary system ; Survival Rate</subject><ispartof>American journal of transplantation, 2011-08, Vol.11 (8), p.1665-1675</ispartof><rights>©</rights><rights>2015 INIST-CNRS</rights><rights>2011 The Authors Journal compilation©2011 The American Society of Transplantation and the American Society of Transplant Surgeons.</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-c5187-3e0f1b3cdca7d172a45568ccde964062e7fbfc34c8fa20a9e328600f92ff8a363</citedby><cites>FETCH-LOGICAL-c5187-3e0f1b3cdca7d172a45568ccde964062e7fbfc34c8fa20a9e328600f92ff8a363</cites><orcidid>0000-0002-0715-6468</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1600-6143.2011.03637.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1600-6143.2011.03637.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24519757$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21797975$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://inserm.hal.science/inserm-00926380$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Lebranchu, Y.</creatorcontrib><creatorcontrib>Thierry, A.</creatorcontrib><creatorcontrib>Thervet, E.</creatorcontrib><creatorcontrib>Büchler, M.</creatorcontrib><creatorcontrib>Etienne, I.</creatorcontrib><creatorcontrib>Westeel, P. F.</creatorcontrib><creatorcontrib>de Ligny, B. Hurault</creatorcontrib><creatorcontrib>Moulin, B.</creatorcontrib><creatorcontrib>Rérolle, J. P.</creatorcontrib><creatorcontrib>Frouget, T.</creatorcontrib><creatorcontrib>Girardot‐Seguin, S.</creatorcontrib><creatorcontrib>Toupance, O.</creatorcontrib><title>Efficacy and Safety of Early Cyclosporine Conversion to Sirolimus with Continued MMF—Four‐Year Results of the Postconcept Study</title><title>American journal of transplantation</title><addtitle>Am J Transplant</addtitle><description>Calcineurin inhibitor (CNI) withdrawal has been used as a strategy to improve renal allograft function. We previously reported that conversion from cyclosporine A (CsA) to sirolimus (SRL) 3 months after transplantation significantly improved renal function at 1 year. In the Postconcept trial, 77 patients in the SRL group and 85 in the CsA group were followed for 48 months. Renal function (Cockcroft and Gault) was significantly better at month 48 (M48) in the SRL group both in the intent‐to‐treat population (ITT): 62.6 mL/min/1.73 m2 versus 57.1 mL/min/1.73 m2 (p = 0.013) and in the on‐treatment population (OT): 67.5 mL/min/1.73 m2 versus 57.4 mL/min/1.73 m2 (p = 0.002). Two biopsy proven acute rejection episodes occurred after M12 in each group. Graft and patient survival were comparable (graft survival: 97.4 vs. 100%; patient survival: 97.4 vs. 97.6%, respectively). The incidence of new‐onset diabetes was numerically increased in the SRL group (7 vs. 2). In OT, three cancers occurred in the SRL group versus nine in the CsA group and mean proteinuria was increased in the SRL group (0.42 ± 0.44 vs. 0.26 ± 0.37; p = 0.018). In summary, the renal benefits associated with conversion of CsA to SRL, at 3 months posttransplantation, in combination with MMF were maintained for 4 years posttransplantation.
A randomized study of an early cyclosporine to sirolimus conversion at 3 months after transplantation (the CONCEPT study) shows that the renal benefit observed at 1 year is maintained and even more pronounced at 4 years.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Chronic allograft nephropathy</subject><subject>CsA</subject><subject>Cyclosporine</subject><subject>Cyclosporine - adverse effects</subject><subject>Cyclosporine - pharmacology</subject><subject>Cyclosporine - therapeutic use</subject><subject>Female</subject><subject>Graft Survival</subject><subject>Humans</subject><subject>Immunosuppressive Agents</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Immunosuppressive Agents - pharmacology</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Kidney Failure, Chronic</subject><subject>Kidney Failure, Chronic - drug therapy</subject><subject>Kidney Failure, Chronic - physiopathology</subject><subject>Kidney Failure, Chronic - surgery</subject><subject>Kidney Function Tests</subject><subject>Kidney Transplantation</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Miscellaneous</subject><subject>MMF</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Nephropathies. Renovascular diseases. Renal failure</subject><subject>nephrotoxicity</subject><subject>Pharmaceutical sciences</subject><subject>Public health. Hygiene</subject><subject>Public health. Hygiene-occupational medicine</subject><subject>Renal failure</subject><subject>renal function</subject><subject>renal transplantation</subject><subject>Sirolimus</subject><subject>Sirolimus - adverse effects</subject><subject>Sirolimus - pharmacology</subject><subject>Sirolimus - therapeutic use</subject><subject>SRL conversion</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Surgery of the urinary system</subject><subject>Survival Rate</subject><issn>1600-6135</issn><issn>1600-6143</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkctuEzEUhkcIREvhFZA3CBZk8GUungWLKEooKBWIlAUry_EcK45mxqntaTu7SrwAC56wT4KnCWGHsBc-0vnOxf-fJIjglMTzbpuSAuNJQTKWUkxIilnByvT2UXJ6TDw-xiw_SZ55v8WYlJTTp8kJJWUVb36a_JhrbZRUA5JdjVZSQxiQ1WguXTOg2aAa63fWmQ7QzHbX4LyxHQoWrYyzjWl7j25M2IzJYLoeanRxsbi_-7Wwvbu_-_kdpENfwfdN8GPbsAH0xfqgbKdgF9Aq9PXwPHmiZePhxeE9S74t5pez88ny84ePs-lyonLCywkDrMmaqVrJso4_kVmeF1ypGqoiwwWFUq-1YpniWlIsK2CURwF0RbXmMgp0lrzd993IRuycaaUbhJVGnE-XwnQeXCswrmjBOL4mEX-9x3fOXvXgg2iNV9A0sgPbe8F5FWUsijySb_5JkpLnlJX0AeV7VDnrvQN9XIRgMXortmK0TYwWitFb8eCtuI2lLw9T-nUL9bHwj5kReHUApFey0U52yvi_XJaTiJWRe7_nbkwDw38vIKafLseI_QbXCcIF</recordid><startdate>201108</startdate><enddate>201108</enddate><creator>Lebranchu, Y.</creator><creator>Thierry, A.</creator><creator>Thervet, E.</creator><creator>Büchler, M.</creator><creator>Etienne, I.</creator><creator>Westeel, P. F.</creator><creator>de Ligny, B. Hurault</creator><creator>Moulin, B.</creator><creator>Rérolle, J. P.</creator><creator>Frouget, T.</creator><creator>Girardot‐Seguin, S.</creator><creator>Toupance, O.</creator><general>Blackwell Publishing Inc</general><general>Wiley</general><general>Elsevier</general><scope>IQODW</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>7T5</scope><scope>H94</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0002-0715-6468</orcidid></search><sort><creationdate>201108</creationdate><title>Efficacy and Safety of Early Cyclosporine Conversion to Sirolimus with Continued MMF—Four‐Year Results of the Postconcept Study</title><author>Lebranchu, Y. ; Thierry, A. ; Thervet, E. ; Büchler, M. ; Etienne, I. ; Westeel, P. F. ; de Ligny, B. Hurault ; Moulin, B. ; Rérolle, J. P. ; Frouget, T. ; Girardot‐Seguin, S. ; Toupance, O.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5187-3e0f1b3cdca7d172a45568ccde964062e7fbfc34c8fa20a9e328600f92ff8a363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Chronic allograft nephropathy</topic><topic>CsA</topic><topic>Cyclosporine</topic><topic>Cyclosporine - adverse effects</topic><topic>Cyclosporine - pharmacology</topic><topic>Cyclosporine - therapeutic use</topic><topic>Female</topic><topic>Graft Survival</topic><topic>Humans</topic><topic>Immunosuppressive Agents</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Immunosuppressive Agents - pharmacology</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Kidney Failure, Chronic</topic><topic>Kidney Failure, Chronic - drug therapy</topic><topic>Kidney Failure, Chronic - physiopathology</topic><topic>Kidney Failure, Chronic - surgery</topic><topic>Kidney Function Tests</topic><topic>Kidney Transplantation</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Miscellaneous</topic><topic>MMF</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Nephropathies. Renovascular diseases. Renal failure</topic><topic>nephrotoxicity</topic><topic>Pharmaceutical sciences</topic><topic>Public health. Hygiene</topic><topic>Public health. Hygiene-occupational medicine</topic><topic>Renal failure</topic><topic>renal function</topic><topic>renal transplantation</topic><topic>Sirolimus</topic><topic>Sirolimus - adverse effects</topic><topic>Sirolimus - pharmacology</topic><topic>Sirolimus - therapeutic use</topic><topic>SRL conversion</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. 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P.</au><au>Frouget, T.</au><au>Girardot‐Seguin, S.</au><au>Toupance, O.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Early Cyclosporine Conversion to Sirolimus with Continued MMF—Four‐Year Results of the Postconcept Study</atitle><jtitle>American journal of transplantation</jtitle><addtitle>Am J Transplant</addtitle><date>2011-08</date><risdate>2011</risdate><volume>11</volume><issue>8</issue><spage>1665</spage><epage>1675</epage><pages>1665-1675</pages><issn>1600-6135</issn><eissn>1600-6143</eissn><abstract>Calcineurin inhibitor (CNI) withdrawal has been used as a strategy to improve renal allograft function. We previously reported that conversion from cyclosporine A (CsA) to sirolimus (SRL) 3 months after transplantation significantly improved renal function at 1 year. In the Postconcept trial, 77 patients in the SRL group and 85 in the CsA group were followed for 48 months. Renal function (Cockcroft and Gault) was significantly better at month 48 (M48) in the SRL group both in the intent‐to‐treat population (ITT): 62.6 mL/min/1.73 m2 versus 57.1 mL/min/1.73 m2 (p = 0.013) and in the on‐treatment population (OT): 67.5 mL/min/1.73 m2 versus 57.4 mL/min/1.73 m2 (p = 0.002). Two biopsy proven acute rejection episodes occurred after M12 in each group. Graft and patient survival were comparable (graft survival: 97.4 vs. 100%; patient survival: 97.4 vs. 97.6%, respectively). The incidence of new‐onset diabetes was numerically increased in the SRL group (7 vs. 2). In OT, three cancers occurred in the SRL group versus nine in the CsA group and mean proteinuria was increased in the SRL group (0.42 ± 0.44 vs. 0.26 ± 0.37; p = 0.018). In summary, the renal benefits associated with conversion of CsA to SRL, at 3 months posttransplantation, in combination with MMF were maintained for 4 years posttransplantation.
A randomized study of an early cyclosporine to sirolimus conversion at 3 months after transplantation (the CONCEPT study) shows that the renal benefit observed at 1 year is maintained and even more pronounced at 4 years.</abstract><cop>Malden, USA</cop><pub>Blackwell Publishing Inc</pub><pmid>21797975</pmid><doi>10.1111/j.1600-6143.2011.03637.x</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-0715-6468</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | American journal of transplantation, 2011-08, Vol.11 (8), p.1665-1675 |
| issn | 1600-6135 1600-6143 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_inserm_00926380v1 |
| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Biological and medical sciences Chronic allograft nephropathy CsA Cyclosporine Cyclosporine - adverse effects Cyclosporine - pharmacology Cyclosporine - therapeutic use Female Graft Survival Humans Immunosuppressive Agents Immunosuppressive Agents - adverse effects Immunosuppressive Agents - pharmacology Immunosuppressive Agents - therapeutic use Kidney Failure, Chronic Kidney Failure, Chronic - drug therapy Kidney Failure, Chronic - physiopathology Kidney Failure, Chronic - surgery Kidney Function Tests Kidney Transplantation Life Sciences Male Medical sciences Middle Aged Miscellaneous MMF Nephrology. Urinary tract diseases Nephropathies. Renovascular diseases. Renal failure nephrotoxicity Pharmaceutical sciences Public health. Hygiene Public health. Hygiene-occupational medicine Renal failure renal function renal transplantation Sirolimus Sirolimus - adverse effects Sirolimus - pharmacology Sirolimus - therapeutic use SRL conversion Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases Surgery of the urinary system Survival Rate |
| title | Efficacy and Safety of Early Cyclosporine Conversion to Sirolimus with Continued MMF—Four‐Year Results of the Postconcept Study |
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