Mycophenolate mofetil maintenance therapy in renal transplant patients: long-term results of the TranCept STAY study

Background This prospective observational study documented long‐term renal function in transplant recipients receiving mycophenolate mofetil (MMF). Methods Kidney allograft recipients >6 months post‐transplantation, with a glomerular filtration rate (GFR) >20 mL/min, receiving MMF from time of...

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Veröffentlicht in:Clinical transplantation 2012-11, Vol.26 (6), p.919-926
Hauptverfasser: Heemann, Uwe, Kliem, Volker, Budde, Klemens, Hamza, Amir, Jürgensen, Jan Steffen, Juarez, Federico, Arns, Wolfgang, Rath, Thomas, Haller, Hermann
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container_end_page 926
container_issue 6
container_start_page 919
container_title Clinical transplantation
container_volume 26
creator Heemann, Uwe
Kliem, Volker
Budde, Klemens
Hamza, Amir
Jürgensen, Jan Steffen
Juarez, Federico
Arns, Wolfgang
Rath, Thomas
Haller, Hermann
description Background This prospective observational study documented long‐term renal function in transplant recipients receiving mycophenolate mofetil (MMF). Methods Kidney allograft recipients >6 months post‐transplantation, with a glomerular filtration rate (GFR) >20 mL/min, receiving MMF from time of transplantation were enrolled and followed for four yr. Subgroups were identified based on time between transplantation and enrollment: Y 1–2 yr); Y2–5 (>2–5 yr) and Y > 5 (>5 yr). Results A total of 2040 patients were analyzed; 780, 410, 541 and 309 in subgroups Y  5. For all patients combined GFR decreased during the observational period by approximately 1 mL/min/yr (median GFR (mL/min) was 50.8, 50.5, 48.7, and 47.6 at one, two, three, and four yr). Survival estimates for decline in renal function (>20% GFR decline at one time point) were 78%, 66%, 57%, and 51% at one, two, three and four yr, with no significant differences between subgroups (p > 0.05). In adult patients, higher doses of MMF (≥1 g/d) were associated with better GFR outcomes (median GFR (mL/min) 48.1 vs. 39.9 at four yr post‐enrollment; p = 0.0037). When comparing the effects of MMF combined with calcineurin inhibitors (CNIs), GFR was increased with lower doses of tacrolimus or cyclosporin. There were no major tolerability or acute rejection problems and graft survival was similar in all subgroups (graft survival estimates for all patients combined were 99%, 95%, 92%, and 90% at one, two, three, and four yr). Conclusions Long‐term MMF immunosuppression preserves renal function and higher MMF doses combined with lower CNI doses may provide better patient outcomes.
doi_str_mv 10.1111/ctr.12008
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Methods Kidney allograft recipients &gt;6 months post‐transplantation, with a glomerular filtration rate (GFR) &gt;20 mL/min, receiving MMF from time of transplantation were enrolled and followed for four yr. Subgroups were identified based on time between transplantation and enrollment: Y &lt; 1 (6 months–1 yr); Y1–2 (&gt;1–2 yr); Y2–5 (&gt;2–5 yr) and Y &gt; 5 (&gt;5 yr). Results A total of 2040 patients were analyzed; 780, 410, 541 and 309 in subgroups Y &lt; 1, Y1–2, Y2–5 and Y &gt; 5. For all patients combined GFR decreased during the observational period by approximately 1 mL/min/yr (median GFR (mL/min) was 50.8, 50.5, 48.7, and 47.6 at one, two, three, and four yr). Survival estimates for decline in renal function (&gt;20% GFR decline at one time point) were 78%, 66%, 57%, and 51% at one, two, three and four yr, with no significant differences between subgroups (p &gt; 0.05). In adult patients, higher doses of MMF (≥1 g/d) were associated with better GFR outcomes (median GFR (mL/min) 48.1 vs. 39.9 at four yr post‐enrollment; p = 0.0037). When comparing the effects of MMF combined with calcineurin inhibitors (CNIs), GFR was increased with lower doses of tacrolimus or cyclosporin. There were no major tolerability or acute rejection problems and graft survival was similar in all subgroups (graft survival estimates for all patients combined were 99%, 95%, 92%, and 90% at one, two, three, and four yr). Conclusions Long‐term MMF immunosuppression preserves renal function and higher MMF doses combined with lower CNI doses may provide better patient outcomes.</description><identifier>ISSN: 0902-0063</identifier><identifier>EISSN: 1399-0012</identifier><identifier>DOI: 10.1111/ctr.12008</identifier><identifier>PMID: 22994923</identifier><language>eng</language><publisher>Hoboken, NJ: Blackwell Publishing Ltd</publisher><subject>Adult ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiviral agents ; Biological and medical sciences ; Disease Management ; Female ; Follow-Up Studies ; Fundamental and applied biological sciences. Psychology ; Fundamental immunology ; Glomerular Filtration Rate ; Graft Rejection - drug therapy ; Graft Rejection - etiology ; Graft Rejection - mortality ; Graft Survival ; Humans ; Immunosuppressive Agents - therapeutic use ; Kidney Diseases - complications ; Kidney Diseases - surgery ; Kidney Transplantation - adverse effects ; maintenance therapy ; Male ; Medical sciences ; Middle Aged ; mycophenolate mofetil ; Mycophenolic Acid - analogs &amp; derivatives ; Mycophenolic Acid - therapeutic use ; nephrotoxicity ; Pharmacology. Drug treatments ; Prognosis ; Prospective Studies ; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases ; Survival Rate ; Tissue, organ and graft immunology</subject><ispartof>Clinical transplantation, 2012-11, Vol.26 (6), p.919-926</ispartof><rights>2012 John Wiley &amp; Sons A/S.</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fctr.12008$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fctr.12008$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=26651152$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22994923$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Heemann, Uwe</creatorcontrib><creatorcontrib>Kliem, Volker</creatorcontrib><creatorcontrib>Budde, Klemens</creatorcontrib><creatorcontrib>Hamza, Amir</creatorcontrib><creatorcontrib>Jürgensen, Jan Steffen</creatorcontrib><creatorcontrib>Juarez, Federico</creatorcontrib><creatorcontrib>Arns, Wolfgang</creatorcontrib><creatorcontrib>Rath, Thomas</creatorcontrib><creatorcontrib>Haller, Hermann</creatorcontrib><title>Mycophenolate mofetil maintenance therapy in renal transplant patients: long-term results of the TranCept STAY study</title><title>Clinical transplantation</title><addtitle>Clin Transplant</addtitle><description>Background This prospective observational study documented long‐term renal function in transplant recipients receiving mycophenolate mofetil (MMF). Methods Kidney allograft recipients &gt;6 months post‐transplantation, with a glomerular filtration rate (GFR) &gt;20 mL/min, receiving MMF from time of transplantation were enrolled and followed for four yr. Subgroups were identified based on time between transplantation and enrollment: Y &lt; 1 (6 months–1 yr); Y1–2 (&gt;1–2 yr); Y2–5 (&gt;2–5 yr) and Y &gt; 5 (&gt;5 yr). Results A total of 2040 patients were analyzed; 780, 410, 541 and 309 in subgroups Y &lt; 1, Y1–2, Y2–5 and Y &gt; 5. For all patients combined GFR decreased during the observational period by approximately 1 mL/min/yr (median GFR (mL/min) was 50.8, 50.5, 48.7, and 47.6 at one, two, three, and four yr). Survival estimates for decline in renal function (&gt;20% GFR decline at one time point) were 78%, 66%, 57%, and 51% at one, two, three and four yr, with no significant differences between subgroups (p &gt; 0.05). In adult patients, higher doses of MMF (≥1 g/d) were associated with better GFR outcomes (median GFR (mL/min) 48.1 vs. 39.9 at four yr post‐enrollment; p = 0.0037). When comparing the effects of MMF combined with calcineurin inhibitors (CNIs), GFR was increased with lower doses of tacrolimus or cyclosporin. There were no major tolerability or acute rejection problems and graft survival was similar in all subgroups (graft survival estimates for all patients combined were 99%, 95%, 92%, and 90% at one, two, three, and four yr). Conclusions Long‐term MMF immunosuppression preserves renal function and higher MMF doses combined with lower CNI doses may provide better patient outcomes.</description><subject>Adult</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiviral agents</subject><subject>Biological and medical sciences</subject><subject>Disease Management</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Fundamental immunology</subject><subject>Glomerular Filtration Rate</subject><subject>Graft Rejection - drug therapy</subject><subject>Graft Rejection - etiology</subject><subject>Graft Rejection - mortality</subject><subject>Graft Survival</subject><subject>Humans</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Kidney Diseases - complications</subject><subject>Kidney Diseases - surgery</subject><subject>Kidney Transplantation - adverse effects</subject><subject>maintenance therapy</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>mycophenolate mofetil</subject><subject>Mycophenolic Acid - analogs &amp; derivatives</subject><subject>Mycophenolic Acid - therapeutic use</subject><subject>nephrotoxicity</subject><subject>Pharmacology. Drug treatments</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Survival Rate</subject><subject>Tissue, organ and graft immunology</subject><issn>0902-0063</issn><issn>1399-0012</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkU9P3DAQxS3UCraUQ78A8qVSLwH_SZx1b7ACWolStSxC9GI5zgTcOk5qO2rz7WvYhfrip_HvjTzzEHpHyRHN59ikcEQZIcsdtKBcyoIQyl6hBZGEZS34HnoT489cFVRUu2iPMSlLyfgCpS-zGcYH8IPTCXA_dJCsw722PoHX3gBODxD0OGPrccglh1PQPo5O-4RHnSz4FD9iN_j7IkHoMxQnlyIeukcrXmd6BWPC1-uTOxzT1M5v0etOuwgH23sf3ZyfrVefisuvF59XJ5eF5VQui1pybaSRJYAkpikFb5ksu4Y2vGpFzUlTmk7WRnAjylYsDeOMSyMMGJoV8H30YdN3DMPvCWJSvY0GXP46DFNUlPE676iqSUYPt-jU9NCqMdheh1k9byoD77eAjka7Lk9lbPzPCVFRWrHMHW-4P9bB_PJOiXqMSuWo1FNUarX-_iSyo9g4bEzw98Whwy-Vh6wrdXt1oU5_nH4TJanUNf8HEkiVxA</recordid><startdate>201211</startdate><enddate>201211</enddate><creator>Heemann, Uwe</creator><creator>Kliem, Volker</creator><creator>Budde, Klemens</creator><creator>Hamza, Amir</creator><creator>Jürgensen, Jan Steffen</creator><creator>Juarez, Federico</creator><creator>Arns, Wolfgang</creator><creator>Rath, Thomas</creator><creator>Haller, Hermann</creator><general>Blackwell Publishing Ltd</general><general>Wiley</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>201211</creationdate><title>Mycophenolate mofetil maintenance therapy in renal transplant patients: long-term results of the TranCept STAY study</title><author>Heemann, Uwe ; Kliem, Volker ; Budde, Klemens ; Hamza, Amir ; Jürgensen, Jan Steffen ; Juarez, Federico ; Arns, Wolfgang ; Rath, Thomas ; Haller, Hermann</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-i3198-793ac9c94ee90cb463d294fb1b35d6730b4cf97c63c64d68c23239c6cec1323e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adult</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiviral agents</topic><topic>Biological and medical sciences</topic><topic>Disease Management</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Fundamental immunology</topic><topic>Glomerular Filtration Rate</topic><topic>Graft Rejection - drug therapy</topic><topic>Graft Rejection - etiology</topic><topic>Graft Rejection - mortality</topic><topic>Graft Survival</topic><topic>Humans</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Kidney Diseases - complications</topic><topic>Kidney Diseases - surgery</topic><topic>Kidney Transplantation - adverse effects</topic><topic>maintenance therapy</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>mycophenolate mofetil</topic><topic>Mycophenolic Acid - analogs &amp; derivatives</topic><topic>Mycophenolic Acid - therapeutic use</topic><topic>nephrotoxicity</topic><topic>Pharmacology. Drug treatments</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Survival Rate</topic><topic>Tissue, organ and graft immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Heemann, Uwe</creatorcontrib><creatorcontrib>Kliem, Volker</creatorcontrib><creatorcontrib>Budde, Klemens</creatorcontrib><creatorcontrib>Hamza, Amir</creatorcontrib><creatorcontrib>Jürgensen, Jan Steffen</creatorcontrib><creatorcontrib>Juarez, Federico</creatorcontrib><creatorcontrib>Arns, Wolfgang</creatorcontrib><creatorcontrib>Rath, Thomas</creatorcontrib><creatorcontrib>Haller, Hermann</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Heemann, Uwe</au><au>Kliem, Volker</au><au>Budde, Klemens</au><au>Hamza, Amir</au><au>Jürgensen, Jan Steffen</au><au>Juarez, Federico</au><au>Arns, Wolfgang</au><au>Rath, Thomas</au><au>Haller, Hermann</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mycophenolate mofetil maintenance therapy in renal transplant patients: long-term results of the TranCept STAY study</atitle><jtitle>Clinical transplantation</jtitle><addtitle>Clin Transplant</addtitle><date>2012-11</date><risdate>2012</risdate><volume>26</volume><issue>6</issue><spage>919</spage><epage>926</epage><pages>919-926</pages><issn>0902-0063</issn><eissn>1399-0012</eissn><abstract>Background This prospective observational study documented long‐term renal function in transplant recipients receiving mycophenolate mofetil (MMF). Methods Kidney allograft recipients &gt;6 months post‐transplantation, with a glomerular filtration rate (GFR) &gt;20 mL/min, receiving MMF from time of transplantation were enrolled and followed for four yr. Subgroups were identified based on time between transplantation and enrollment: Y &lt; 1 (6 months–1 yr); Y1–2 (&gt;1–2 yr); Y2–5 (&gt;2–5 yr) and Y &gt; 5 (&gt;5 yr). Results A total of 2040 patients were analyzed; 780, 410, 541 and 309 in subgroups Y &lt; 1, Y1–2, Y2–5 and Y &gt; 5. For all patients combined GFR decreased during the observational period by approximately 1 mL/min/yr (median GFR (mL/min) was 50.8, 50.5, 48.7, and 47.6 at one, two, three, and four yr). Survival estimates for decline in renal function (&gt;20% GFR decline at one time point) were 78%, 66%, 57%, and 51% at one, two, three and four yr, with no significant differences between subgroups (p &gt; 0.05). In adult patients, higher doses of MMF (≥1 g/d) were associated with better GFR outcomes (median GFR (mL/min) 48.1 vs. 39.9 at four yr post‐enrollment; p = 0.0037). When comparing the effects of MMF combined with calcineurin inhibitors (CNIs), GFR was increased with lower doses of tacrolimus or cyclosporin. There were no major tolerability or acute rejection problems and graft survival was similar in all subgroups (graft survival estimates for all patients combined were 99%, 95%, 92%, and 90% at one, two, three, and four yr). Conclusions Long‐term MMF immunosuppression preserves renal function and higher MMF doses combined with lower CNI doses may provide better patient outcomes.</abstract><cop>Hoboken, NJ</cop><pub>Blackwell Publishing Ltd</pub><pmid>22994923</pmid><doi>10.1111/ctr.12008</doi><tpages>8</tpages></addata></record>
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source MEDLINE; Wiley Online Library Journals Frontfile Complete
subjects Adult
Antibiotics. Antiinfectious agents. Antiparasitic agents
Antiviral agents
Biological and medical sciences
Disease Management
Female
Follow-Up Studies
Fundamental and applied biological sciences. Psychology
Fundamental immunology
Glomerular Filtration Rate
Graft Rejection - drug therapy
Graft Rejection - etiology
Graft Rejection - mortality
Graft Survival
Humans
Immunosuppressive Agents - therapeutic use
Kidney Diseases - complications
Kidney Diseases - surgery
Kidney Transplantation - adverse effects
maintenance therapy
Male
Medical sciences
Middle Aged
mycophenolate mofetil
Mycophenolic Acid - analogs & derivatives
Mycophenolic Acid - therapeutic use
nephrotoxicity
Pharmacology. Drug treatments
Prognosis
Prospective Studies
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Survival Rate
Tissue, organ and graft immunology
title Mycophenolate mofetil maintenance therapy in renal transplant patients: long-term results of the TranCept STAY study
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