Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: Results after three years

Mycophenolate mofetil (MMF)-based immunosuppression has reduced the acute rejection rate in adults and in children in the early posttransplantation period. Three-year posttransplantation results have been reported for adults but not for children thus far. In the present open-labeled study, patients...

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Veröffentlicht in:Transplantation 2003-02, Vol.75 (4), p.454-461
Hauptverfasser: JUNGRAITHMAYR, Therese, STASKEWITZ, Astrid, KLAUS, Günter, LEICHTER, Heinz E, MIHATSCH, Michael J, MICHALK, Dietrich V, MISSELWITZ, Joachim, PLANK, Christian, QUERFELD, Uwe, WEBER, Lutz T, WIESEL, Manfred, TÖNSHOFF, Burkhard, KIRSTE, Günter, ZIMMERHACKL, Lothar B, BÖSWALD, Michael, BULLA, Monika, BURGHARD, Rainer, DIPPELL, Jürgen, GREINER, Christel, HELMCHEN, Udo, KLARE, Bernd
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container_issue 4
container_start_page 454
container_title Transplantation
container_volume 75
creator JUNGRAITHMAYR, Therese
STASKEWITZ, Astrid
KLAUS, Günter
LEICHTER, Heinz E
MIHATSCH, Michael J
MICHALK, Dietrich V
MISSELWITZ, Joachim
PLANK, Christian
QUERFELD, Uwe
WEBER, Lutz T
WIESEL, Manfred
TÖNSHOFF, Burkhard
KIRSTE, Günter
ZIMMERHACKL, Lothar B
BÖSWALD, Michael
BULLA, Monika
BURGHARD, Rainer
DIPPELL, Jürgen
GREINER, Christel
HELMCHEN, Udo
KLARE, Bernd
description Mycophenolate mofetil (MMF)-based immunosuppression has reduced the acute rejection rate in adults and in children in the early posttransplantation period. Three-year posttransplantation results have been reported for adults but not for children thus far. In the present open-labeled study, patients 18 years old and younger were evaluated prospectively for up to 3 years after renal transplantation (RTX). Eighty-six patients receiving MMF in combination with cyclosporine and prednisone without induction were evaluated for patient survival, transplant survival, renal function, arterial blood pressure, adverse events, and opportunistic infections. These patients were compared with a historic control group (n=54) receiving azathioprine (AZA) instead of MMF. Patient survival after 3 years was 98.8% in the MMF group and 94.4% in the AZA group (NS). Intent-to-treat analysis of graft survival demonstrated superiority for MMF (98% vs. 80%; P
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Three-year posttransplantation results have been reported for adults but not for children thus far. In the present open-labeled study, patients 18 years old and younger were evaluated prospectively for up to 3 years after renal transplantation (RTX). Eighty-six patients receiving MMF in combination with cyclosporine and prednisone without induction were evaluated for patient survival, transplant survival, renal function, arterial blood pressure, adverse events, and opportunistic infections. These patients were compared with a historic control group (n=54) receiving azathioprine (AZA) instead of MMF. Patient survival after 3 years was 98.8% in the MMF group and 94.4% in the AZA group (NS). Intent-to-treat analysis of graft survival demonstrated superiority for MMF (98% vs. 80%; P&lt;0.001). Cumulative acute rejection episodes occurred in 47% of patients in the MMF group versus 61% in the AZA group (P&lt;0.05). Renal function was not significantly different, neither after 3 years nor in the long-term calculation. Antihypertensive medication was administered to 73% to 84% of patients, similar in both groups. Opportunistic infections were recorded only for MMF. Infection rates were comparable to those reported in adults. These results suggest that MMF is safe and beneficial as a longer term maintenance immunosuppressive drug in children and adolescents.</description><identifier>ISSN: 0041-1337</identifier><identifier>EISSN: 1534-6080</identifier><identifier>DOI: 10.1097/01.TP.0000045748.95874.64</identifier><identifier>PMID: 12605109</identifier><identifier>CODEN: TRPLAU</identifier><language>eng</language><publisher>Hagerstown, MD: Lippincott</publisher><subject>Acute Disease ; Adolescent ; Azathioprine - administration &amp; dosage ; Biological and medical sciences ; Blood Pressure ; Child ; Cyclosporine - administration &amp; dosage ; Female ; Follow-Up Studies ; Graft Rejection - drug therapy ; Graft Rejection - mortality ; Graft Survival - drug effects ; Humans ; Hypertension - diagnosis ; Hypertension - therapy ; Immunomodulators ; Immunosuppressive Agents - administration &amp; dosage ; Immunosuppressive Agents - adverse effects ; Kidney - physiology ; Kidney Transplantation ; Male ; Medical sciences ; Mycophenolic Acid - administration &amp; dosage ; Mycophenolic Acid - adverse effects ; Mycophenolic Acid - analogs &amp; derivatives ; Pharmacology. Drug treatments ; Prospective Studies ; Surgery (general aspects). Transplantations, organ and tissue grafts. 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Three-year posttransplantation results have been reported for adults but not for children thus far. In the present open-labeled study, patients 18 years old and younger were evaluated prospectively for up to 3 years after renal transplantation (RTX). Eighty-six patients receiving MMF in combination with cyclosporine and prednisone without induction were evaluated for patient survival, transplant survival, renal function, arterial blood pressure, adverse events, and opportunistic infections. These patients were compared with a historic control group (n=54) receiving azathioprine (AZA) instead of MMF. Patient survival after 3 years was 98.8% in the MMF group and 94.4% in the AZA group (NS). Intent-to-treat analysis of graft survival demonstrated superiority for MMF (98% vs. 80%; P&lt;0.001). Cumulative acute rejection episodes occurred in 47% of patients in the MMF group versus 61% in the AZA group (P&lt;0.05). Renal function was not significantly different, neither after 3 years nor in the long-term calculation. Antihypertensive medication was administered to 73% to 84% of patients, similar in both groups. Opportunistic infections were recorded only for MMF. Infection rates were comparable to those reported in adults. 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Drug treatments</subject><subject>Prospective Studies</subject><subject>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</subject><subject>Surgery of the urinary system</subject><subject>Treatment Outcome</subject><issn>0041-1337</issn><issn>1534-6080</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkEtLxDAUhYMozvj4CxIXumtNmjZJ3Yn4ggFFdF3S5IaJ9GWSIrPyr5vBEe_mLu53DvcchM4pySmpxRWh-dtLTrZTVqKUeV1JUea83ENLWrEy40SSfbRMZ5pRxsQCHYXwkfCKCXGIFrTgpEpWS_T9Asap6J3GHgbV4ejVEKZODVFFNw74y8U17jd6nNYwjJ2KgPvRQnRd1qoABru-n4cxzNPkIYQ_yThH7AYz663JNX6FMHcxYGUjeBzXHgBvQPlwgg6s6gKc7vYxer-_e7t9zFbPD0-3N6tsKriMGWhBuNAKrDQ6ZU7vC2lbKIzkupDCWq4qWhvO2raygpCiMqWhRkhojWTAjtHlr-_kx88ZQmx6FzR0KSiMc2ioFDUvijqBZztwbnswzeRdr_ym-assARc7QAWtOpv60i78cyUnBWGU_QCd4YFJ</recordid><startdate>20030227</startdate><enddate>20030227</enddate><creator>JUNGRAITHMAYR, Therese</creator><creator>STASKEWITZ, Astrid</creator><creator>KLAUS, Günter</creator><creator>LEICHTER, Heinz E</creator><creator>MIHATSCH, Michael J</creator><creator>MICHALK, Dietrich V</creator><creator>MISSELWITZ, Joachim</creator><creator>PLANK, Christian</creator><creator>QUERFELD, Uwe</creator><creator>WEBER, Lutz T</creator><creator>WIESEL, Manfred</creator><creator>TÖNSHOFF, Burkhard</creator><creator>KIRSTE, Günter</creator><creator>ZIMMERHACKL, Lothar B</creator><creator>BÖSWALD, Michael</creator><creator>BULLA, Monika</creator><creator>BURGHARD, Rainer</creator><creator>DIPPELL, Jürgen</creator><creator>GREINER, Christel</creator><creator>HELMCHEN, Udo</creator><creator>KLARE, Bernd</creator><general>Lippincott</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20030227</creationdate><title>Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: Results after three years</title><author>JUNGRAITHMAYR, Therese ; STASKEWITZ, Astrid ; KLAUS, Günter ; LEICHTER, Heinz E ; MIHATSCH, Michael J ; MICHALK, Dietrich V ; MISSELWITZ, Joachim ; PLANK, Christian ; QUERFELD, Uwe ; WEBER, Lutz T ; WIESEL, Manfred ; TÖNSHOFF, Burkhard ; KIRSTE, Günter ; ZIMMERHACKL, Lothar B ; BÖSWALD, Michael ; BULLA, Monika ; BURGHARD, Rainer ; DIPPELL, Jürgen ; GREINER, Christel ; HELMCHEN, Udo ; KLARE, Bernd</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p268t-ec7067caef8dc45760578fbe2d86c287ff6a519d63bb5f70025d4d1d78ebd83e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Acute Disease</topic><topic>Adolescent</topic><topic>Azathioprine - administration &amp; dosage</topic><topic>Biological and medical sciences</topic><topic>Blood Pressure</topic><topic>Child</topic><topic>Cyclosporine - administration &amp; dosage</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Graft Rejection - drug therapy</topic><topic>Graft Rejection - mortality</topic><topic>Graft Survival - drug effects</topic><topic>Humans</topic><topic>Hypertension - diagnosis</topic><topic>Hypertension - therapy</topic><topic>Immunomodulators</topic><topic>Immunosuppressive Agents - administration &amp; dosage</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Kidney - physiology</topic><topic>Kidney Transplantation</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Mycophenolic Acid - administration &amp; dosage</topic><topic>Mycophenolic Acid - adverse effects</topic><topic>Mycophenolic Acid - analogs &amp; derivatives</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases</topic><topic>Surgery of the urinary system</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>JUNGRAITHMAYR, Therese</creatorcontrib><creatorcontrib>STASKEWITZ, Astrid</creatorcontrib><creatorcontrib>KLAUS, Günter</creatorcontrib><creatorcontrib>LEICHTER, Heinz E</creatorcontrib><creatorcontrib>MIHATSCH, Michael J</creatorcontrib><creatorcontrib>MICHALK, Dietrich V</creatorcontrib><creatorcontrib>MISSELWITZ, Joachim</creatorcontrib><creatorcontrib>PLANK, Christian</creatorcontrib><creatorcontrib>QUERFELD, Uwe</creatorcontrib><creatorcontrib>WEBER, Lutz T</creatorcontrib><creatorcontrib>WIESEL, Manfred</creatorcontrib><creatorcontrib>TÖNSHOFF, Burkhard</creatorcontrib><creatorcontrib>KIRSTE, Günter</creatorcontrib><creatorcontrib>ZIMMERHACKL, Lothar B</creatorcontrib><creatorcontrib>BÖSWALD, Michael</creatorcontrib><creatorcontrib>BULLA, Monika</creatorcontrib><creatorcontrib>BURGHARD, Rainer</creatorcontrib><creatorcontrib>DIPPELL, Jürgen</creatorcontrib><creatorcontrib>GREINER, Christel</creatorcontrib><creatorcontrib>HELMCHEN, Udo</creatorcontrib><creatorcontrib>KLARE, Bernd</creatorcontrib><creatorcontrib>German Pediatric Renal Transplantation Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>JUNGRAITHMAYR, Therese</au><au>STASKEWITZ, Astrid</au><au>KLAUS, Günter</au><au>LEICHTER, Heinz E</au><au>MIHATSCH, Michael J</au><au>MICHALK, Dietrich V</au><au>MISSELWITZ, Joachim</au><au>PLANK, Christian</au><au>QUERFELD, Uwe</au><au>WEBER, Lutz T</au><au>WIESEL, Manfred</au><au>TÖNSHOFF, Burkhard</au><au>KIRSTE, Günter</au><au>ZIMMERHACKL, Lothar B</au><au>BÖSWALD, Michael</au><au>BULLA, Monika</au><au>BURGHARD, Rainer</au><au>DIPPELL, Jürgen</au><au>GREINER, Christel</au><au>HELMCHEN, Udo</au><au>KLARE, Bernd</au><aucorp>German Pediatric Renal Transplantation Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: Results after three years</atitle><jtitle>Transplantation</jtitle><addtitle>Transplantation</addtitle><date>2003-02-27</date><risdate>2003</risdate><volume>75</volume><issue>4</issue><spage>454</spage><epage>461</epage><pages>454-461</pages><issn>0041-1337</issn><eissn>1534-6080</eissn><coden>TRPLAU</coden><abstract>Mycophenolate mofetil (MMF)-based immunosuppression has reduced the acute rejection rate in adults and in children in the early posttransplantation period. Three-year posttransplantation results have been reported for adults but not for children thus far. In the present open-labeled study, patients 18 years old and younger were evaluated prospectively for up to 3 years after renal transplantation (RTX). Eighty-six patients receiving MMF in combination with cyclosporine and prednisone without induction were evaluated for patient survival, transplant survival, renal function, arterial blood pressure, adverse events, and opportunistic infections. These patients were compared with a historic control group (n=54) receiving azathioprine (AZA) instead of MMF. Patient survival after 3 years was 98.8% in the MMF group and 94.4% in the AZA group (NS). Intent-to-treat analysis of graft survival demonstrated superiority for MMF (98% vs. 80%; P&lt;0.001). Cumulative acute rejection episodes occurred in 47% of patients in the MMF group versus 61% in the AZA group (P&lt;0.05). Renal function was not significantly different, neither after 3 years nor in the long-term calculation. Antihypertensive medication was administered to 73% to 84% of patients, similar in both groups. Opportunistic infections were recorded only for MMF. Infection rates were comparable to those reported in adults. These results suggest that MMF is safe and beneficial as a longer term maintenance immunosuppressive drug in children and adolescents.</abstract><cop>Hagerstown, MD</cop><pub>Lippincott</pub><pmid>12605109</pmid><doi>10.1097/01.TP.0000045748.95874.64</doi><tpages>8</tpages></addata></record>
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subjects Acute Disease
Adolescent
Azathioprine - administration & dosage
Biological and medical sciences
Blood Pressure
Child
Cyclosporine - administration & dosage
Female
Follow-Up Studies
Graft Rejection - drug therapy
Graft Rejection - mortality
Graft Survival - drug effects
Humans
Hypertension - diagnosis
Hypertension - therapy
Immunomodulators
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
Kidney - physiology
Kidney Transplantation
Male
Medical sciences
Mycophenolic Acid - administration & dosage
Mycophenolic Acid - adverse effects
Mycophenolic Acid - analogs & derivatives
Pharmacology. Drug treatments
Prospective Studies
Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases
Surgery of the urinary system
Treatment Outcome
title Pediatric renal transplantation with mycophenolate mofetil-based immunosuppression without induction: Results after three years
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