Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial
As part of the Spare-the-Nephron trial, we evaluated the combination mycophenolate mofetil (MMF) and sirolimus (SRL) as a calcineurin inhibitor (CNI)-free regimen for the preservation of renal function in renal allograft recipients. This 2-year, open-label, multicenter trial randomized 299 patients...
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| Veröffentlicht in: | Kidney international 2011-04, Vol.79 (8), p.897-907 |
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| creator | Weir, Matthew R. Mulgaonkar, Shamkant Chan, Laurence Shidban, Hamid Waid, Thomas H. Preston, Dennis Kalil, Roberto N. Pearson, Thomas C. |
| description | As part of the Spare-the-Nephron trial, we evaluated the combination mycophenolate mofetil (MMF) and sirolimus (SRL) as a calcineurin inhibitor (CNI)-free regimen for the preservation of renal function in renal allograft recipients. This 2-year, open-label, multicenter trial randomized 299 patients of which 151 were maintained on MMF and a CNI, 148 on MMF plus SRL (n=120, tacrolimus; n=31, cyclosporine). Baseline characteristics including measured (iothalamate) glomerular filtration rate (GFR) were similar between groups. After 1 year, the mean percentage change from baseline in the primary end point of measured GFR was significantly higher in the MMF/SRL group compared with the MMF/CNI group. After 2 years, the change was indistinguishable. Calculated creatinine clearance and GFR were significantly greater with MMF/SRL at 2 years within which biopsy-proven acute rejection (BPAR) occurred in 14 MMF/SRL-treated patients (3 graft losses) and in 17 receiving the MMF/CNI (6 graft losses). Significantly, no patients receiving MMF/SRL but five treated with MMF/CNI died. Thus, compared with MMF/CNI treatment, a 2-year regimen of MMF/SRL resulted in similar measures of renal function but with fewer deaths and a trend to less BPAR and graft loss. |
| doi_str_mv | 10.1038/ki.2010.492 |
| format | Article |
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This 2-year, open-label, multicenter trial randomized 299 patients of which 151 were maintained on MMF and a CNI, 148 on MMF plus SRL (n=120, tacrolimus; n=31, cyclosporine). Baseline characteristics including measured (iothalamate) glomerular filtration rate (GFR) were similar between groups. After 1 year, the mean percentage change from baseline in the primary end point of measured GFR was significantly higher in the MMF/SRL group compared with the MMF/CNI group. After 2 years, the change was indistinguishable. Calculated creatinine clearance and GFR were significantly greater with MMF/SRL at 2 years within which biopsy-proven acute rejection (BPAR) occurred in 14 MMF/SRL-treated patients (3 graft losses) and in 17 receiving the MMF/CNI (6 graft losses). Significantly, no patients receiving MMF/SRL but five treated with MMF/CNI died. Thus, compared with MMF/CNI treatment, a 2-year regimen of MMF/SRL resulted in similar measures of renal function but with fewer deaths and a trend to less BPAR and graft loss.</description><identifier>ISSN: 0085-2538</identifier><identifier>EISSN: 1523-1755</identifier><identifier>DOI: 10.1038/ki.2010.492</identifier><identifier>PMID: 21191361</identifier><identifier>CODEN: KDYIA5</identifier><language>eng</language><publisher>Basingstoke: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Biological and medical sciences ; calcineurin inhibitor ; Calcineurin Inhibitors ; Clinical trials ; Creatinine ; Creatinine - blood ; Cyclosporins ; Female ; Glomerular filtration rate ; Glomerular Filtration Rate - drug effects ; Graft rejection ; Graft Rejection - etiology ; Graft Rejection - prevention & control ; Humans ; Immunosuppression ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - adverse effects ; Kidney transplantation ; Kidney Transplantation - adverse effects ; Kidney Transplantation - methods ; Kidney Transplantation - physiology ; Male ; Medical sciences ; Middle Aged ; Mycophenolate mofetil ; Mycophenolic acid ; Mycophenolic Acid - administration & dosage ; Mycophenolic Acid - adverse effects ; Mycophenolic Acid - analogs & derivatives ; Nephrology. Urinary tract diseases ; Nephrons - drug effects ; Nephrons - physiopathology ; Preservation ; Prospective Studies ; Renal function ; sirolimus ; Sirolimus - administration & dosage ; Sirolimus - adverse effects ; Tacrolimus ; Treatment Outcome ; Young Adult</subject><ispartof>Kidney international, 2011-04, Vol.79 (8), p.897-907</ispartof><rights>2011 International Society of Nephrology</rights><rights>2015 INIST-CNRS</rights><rights>Copyright Nature Publishing Group Apr 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c461t-e547672435298e32b5da5f9852ca985684097c5ade5c27558b7808d89a65f813</citedby><cites>FETCH-LOGICAL-c461t-e547672435298e32b5da5f9852ca985684097c5ade5c27558b7808d89a65f813</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24030880$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21191361$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Weir, Matthew R.</creatorcontrib><creatorcontrib>Mulgaonkar, Shamkant</creatorcontrib><creatorcontrib>Chan, Laurence</creatorcontrib><creatorcontrib>Shidban, Hamid</creatorcontrib><creatorcontrib>Waid, Thomas H.</creatorcontrib><creatorcontrib>Preston, Dennis</creatorcontrib><creatorcontrib>Kalil, Roberto N.</creatorcontrib><creatorcontrib>Pearson, Thomas C.</creatorcontrib><title>Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial</title><title>Kidney international</title><addtitle>Kidney Int</addtitle><description>As part of the Spare-the-Nephron trial, we evaluated the combination mycophenolate mofetil (MMF) and sirolimus (SRL) as a calcineurin inhibitor (CNI)-free regimen for the preservation of renal function in renal allograft recipients. This 2-year, open-label, multicenter trial randomized 299 patients of which 151 were maintained on MMF and a CNI, 148 on MMF plus SRL (n=120, tacrolimus; n=31, cyclosporine). Baseline characteristics including measured (iothalamate) glomerular filtration rate (GFR) were similar between groups. After 1 year, the mean percentage change from baseline in the primary end point of measured GFR was significantly higher in the MMF/SRL group compared with the MMF/CNI group. After 2 years, the change was indistinguishable. Calculated creatinine clearance and GFR were significantly greater with MMF/SRL at 2 years within which biopsy-proven acute rejection (BPAR) occurred in 14 MMF/SRL-treated patients (3 graft losses) and in 17 receiving the MMF/CNI (6 graft losses). Significantly, no patients receiving MMF/SRL but five treated with MMF/CNI died. Thus, compared with MMF/CNI treatment, a 2-year regimen of MMF/SRL resulted in similar measures of renal function but with fewer deaths and a trend to less BPAR and graft loss.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>calcineurin inhibitor</subject><subject>Calcineurin Inhibitors</subject><subject>Clinical trials</subject><subject>Creatinine</subject><subject>Creatinine - blood</subject><subject>Cyclosporins</subject><subject>Female</subject><subject>Glomerular filtration rate</subject><subject>Glomerular Filtration Rate - drug effects</subject><subject>Graft rejection</subject><subject>Graft Rejection - etiology</subject><subject>Graft Rejection - prevention & control</subject><subject>Humans</subject><subject>Immunosuppression</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Kidney transplantation</subject><subject>Kidney Transplantation - adverse effects</subject><subject>Kidney Transplantation - methods</subject><subject>Kidney Transplantation - physiology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Mycophenolate mofetil</subject><subject>Mycophenolic acid</subject><subject>Mycophenolic Acid - administration & dosage</subject><subject>Mycophenolic Acid - adverse effects</subject><subject>Mycophenolic Acid - analogs & derivatives</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Nephrons - drug effects</subject><subject>Nephrons - physiopathology</subject><subject>Preservation</subject><subject>Prospective Studies</subject><subject>Renal function</subject><subject>sirolimus</subject><subject>Sirolimus - administration & dosage</subject><subject>Sirolimus - adverse effects</subject><subject>Tacrolimus</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0085-2538</issn><issn>1523-1755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kU1rFTEUhoMo9lpduZcgiIJOzedM4k6KX1B1YfdDbuYMN21mMiYZpf4B_7an3quCiJuEE548HN6XkPucnXAmzfPLcCIYDsqKG2TDtZAN77S-STaMGd0ILc0RuVPKBcPZSnabHAnOLZct35Dv7698WnYwp-gq0CmNUENstq7AQMM0rXMq67JkKCWkmX4NdUdLyCmGaS00zDTD7CKt2c1liW6uriL3gjqKL0OawjcYnlGf5op_Ijo_LS5DU3fQfIBll9FZc3DxLrk1uljg3uE-JuevX52fvm3OPr55d_ryrPGq5bUBrbq2E0pqYQ1IsdWD06M1WniHZ2sUs53XbgDtBYZgtp1hZjDWtXo0XB6Tx3vtktPnFUrtp1A8RNwc0lp6o22npDAdkk_-S3JmpVIYvEb04V_oRVozxvLT1wrVCovQ0z3kcyolw9gvOUwuX6Gpv-6xvwz9dY899oj0g4Ny3U4w_GZ_FYfAowPgindxxLR9KH84xSQzhiGn9xxgqF8C5L74ALOHIWTwtR9S-OcCPwBJKLh3</recordid><startdate>20110401</startdate><enddate>20110401</enddate><creator>Weir, Matthew R.</creator><creator>Mulgaonkar, Shamkant</creator><creator>Chan, Laurence</creator><creator>Shidban, Hamid</creator><creator>Waid, Thomas H.</creator><creator>Preston, Dennis</creator><creator>Kalil, Roberto N.</creator><creator>Pearson, Thomas C.</creator><general>Elsevier Inc</general><general>Nature Publishing Group</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><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>3V.</scope><scope>7QP</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7T5</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>20110401</creationdate><title>Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial</title><author>Weir, Matthew R. ; Mulgaonkar, Shamkant ; Chan, Laurence ; Shidban, Hamid ; Waid, Thomas H. ; Preston, Dennis ; Kalil, Roberto N. ; Pearson, Thomas C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c461t-e547672435298e32b5da5f9852ca985684097c5ade5c27558b7808d89a65f813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>calcineurin inhibitor</topic><topic>Calcineurin Inhibitors</topic><topic>Clinical trials</topic><topic>Creatinine</topic><topic>Creatinine - blood</topic><topic>Cyclosporins</topic><topic>Female</topic><topic>Glomerular filtration rate</topic><topic>Glomerular Filtration Rate - drug effects</topic><topic>Graft rejection</topic><topic>Graft Rejection - etiology</topic><topic>Graft Rejection - prevention & control</topic><topic>Humans</topic><topic>Immunosuppression</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Kidney transplantation</topic><topic>Kidney Transplantation - adverse effects</topic><topic>Kidney Transplantation - methods</topic><topic>Kidney Transplantation - physiology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Mycophenolate mofetil</topic><topic>Mycophenolic acid</topic><topic>Mycophenolic Acid - administration & dosage</topic><topic>Mycophenolic Acid - adverse effects</topic><topic>Mycophenolic Acid - analogs & derivatives</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Nephrons - drug effects</topic><topic>Nephrons - physiopathology</topic><topic>Preservation</topic><topic>Prospective Studies</topic><topic>Renal function</topic><topic>sirolimus</topic><topic>Sirolimus - administration & dosage</topic><topic>Sirolimus - adverse effects</topic><topic>Tacrolimus</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Weir, Matthew R.</creatorcontrib><creatorcontrib>Mulgaonkar, Shamkant</creatorcontrib><creatorcontrib>Chan, Laurence</creatorcontrib><creatorcontrib>Shidban, Hamid</creatorcontrib><creatorcontrib>Waid, Thomas H.</creatorcontrib><creatorcontrib>Preston, Dennis</creatorcontrib><creatorcontrib>Kalil, Roberto N.</creatorcontrib><creatorcontrib>Pearson, Thomas C.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</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>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Kidney international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Weir, Matthew R.</au><au>Mulgaonkar, Shamkant</au><au>Chan, Laurence</au><au>Shidban, Hamid</au><au>Waid, Thomas H.</au><au>Preston, Dennis</au><au>Kalil, Roberto N.</au><au>Pearson, Thomas C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial</atitle><jtitle>Kidney international</jtitle><addtitle>Kidney Int</addtitle><date>2011-04-01</date><risdate>2011</risdate><volume>79</volume><issue>8</issue><spage>897</spage><epage>907</epage><pages>897-907</pages><issn>0085-2538</issn><eissn>1523-1755</eissn><coden>KDYIA5</coden><abstract>As part of the Spare-the-Nephron trial, we evaluated the combination mycophenolate mofetil (MMF) and sirolimus (SRL) as a calcineurin inhibitor (CNI)-free regimen for the preservation of renal function in renal allograft recipients. This 2-year, open-label, multicenter trial randomized 299 patients of which 151 were maintained on MMF and a CNI, 148 on MMF plus SRL (n=120, tacrolimus; n=31, cyclosporine). Baseline characteristics including measured (iothalamate) glomerular filtration rate (GFR) were similar between groups. After 1 year, the mean percentage change from baseline in the primary end point of measured GFR was significantly higher in the MMF/SRL group compared with the MMF/CNI group. After 2 years, the change was indistinguishable. Calculated creatinine clearance and GFR were significantly greater with MMF/SRL at 2 years within which biopsy-proven acute rejection (BPAR) occurred in 14 MMF/SRL-treated patients (3 graft losses) and in 17 receiving the MMF/CNI (6 graft losses). Significantly, no patients receiving MMF/SRL but five treated with MMF/CNI died. Thus, compared with MMF/CNI treatment, a 2-year regimen of MMF/SRL resulted in similar measures of renal function but with fewer deaths and a trend to less BPAR and graft loss.</abstract><cop>Basingstoke</cop><pub>Elsevier Inc</pub><pmid>21191361</pmid><doi>10.1038/ki.2010.492</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Kidney international, 2011-04, Vol.79 (8), p.897-907 |
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| subjects | Adolescent Adult Aged Biological and medical sciences calcineurin inhibitor Calcineurin Inhibitors Clinical trials Creatinine Creatinine - blood Cyclosporins Female Glomerular filtration rate Glomerular Filtration Rate - drug effects Graft rejection Graft Rejection - etiology Graft Rejection - prevention & control Humans Immunosuppression Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - adverse effects Kidney transplantation Kidney Transplantation - adverse effects Kidney Transplantation - methods Kidney Transplantation - physiology Male Medical sciences Middle Aged Mycophenolate mofetil Mycophenolic acid Mycophenolic Acid - administration & dosage Mycophenolic Acid - adverse effects Mycophenolic Acid - analogs & derivatives Nephrology. Urinary tract diseases Nephrons - drug effects Nephrons - physiopathology Preservation Prospective Studies Renal function sirolimus Sirolimus - administration & dosage Sirolimus - adverse effects Tacrolimus Treatment Outcome Young Adult |
| title | Mycophenolate mofetil-based immunosuppression with sirolimus in renal transplantation: a randomized, controlled Spare-the-Nephron trial |
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