Conversion of Long-Term Kidney Transplant Recipients From Calcineurin Inhibitor Therapy to Everolimus: A Randomized, Multicenter, 24-Month Study
Identifieur interne : 006C28 ( Main/Exploration ); précédent : 006C27; suivant : 006C29Conversion of Long-Term Kidney Transplant Recipients From Calcineurin Inhibitor Therapy to Everolimus: A Randomized, Multicenter, 24-Month Study
Auteurs : Hallvard Holdaas [Norvège] ; Lionel Rostaing [France] ; Daniel Seron [Espagne] ; Edward Cole [Canada] ; Jeremy Chapman [Australie] ; Bengt Fellstr M [Suède] ; Erik H. Strom [Norvège] ; Alan Jardine [Royaume-Uni] ; Karsten Midtvedt [Norvège] ; Uwe Machein [Suisse] ; Bettina Ulbricht [Suisse] ; Alexander Karpov [Suisse] ; Philip J. O'Connell [Australie]Source :
- Transplantation [ 0041-1337 ] ; 2011.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Background. Benefits of conversion from calcineurin inhibitor (CNI) to mammalian target of rapamycin inhibitor-based immunosuppression in long-term kidney transplant patients remain uncertain. Methods. ASCERTAIN was a 24-month, open-label, multicenter study. Kidney transplant patients more than 6 months posttransplant receiving CNI (baseline glomerular filtration rate [GFR] 30-70 mL/min/1.73 m2) were randomized to everolimus with CNI elimination (n= 127) or CNI minimization (n= 144), or continued CNI unchanged (controls, n= 123) to assess the effect on measured GFR at month 24 after randomization. Results. Renal function was stable in all groups to month 24. Mean measured GFR at month 24, the primary endpoint, was 48.0±22.0 mL/min/1.73 m2, 46.6±21.1 mL/min/1.73 m2, and 46.0±20.4 mL/min/1.73 m2 in the CNI elimination, CNI minimization, and control groups, respectively. Differences between CNI elimination (1.12 mL/min/1.73 m2, 95% confidence interval [CI] -3.51 to 5.76, P=0.63) and CNI minimization (0.59 mL/min/1.73 m2, 95% CI -3.88 to 5.07, P=0.79) versus controls at month 24 were nonsignificant that is, the primary endpoint was not met. No efficacy endpoint differed significantly between groups. Post hoc analyses showed that patients with baseline creatinine clearance (CrCl) more than 50 mL/min had a significantly greater increase in measured GFR after CNI elimination versus controls (difference 11.4 mL/min/1.73 m2, 95% CI 2.1 to 20.8 mL/min/1.73 m2, P=0.017). Adverse events resulted in discontinuation in 36 (28.3%) CNI elimination patients, 24 (16.7%) CNI minimization patients, and 5 (4.1%) controls (P<0.001 vs. CNI elimination; P=0.020 vs. CNI minimization). Conclusion. Conversion to everolimus with CNI elimination or minimization a mean of 5.6 years after kidney transplantation had no overall renal benefit and was associated with more frequent adverse events and discontinuations. Patients with CrCl more than 50 mL/min may benefit from a change in therapy more than 6 months after renal transplantation.
Affiliations:
- Australie, Canada, Espagne, France, Norvège, Royaume-Uni, Suisse, Suède
- Midi-Pyrénées, Occitanie (région administrative), Ontario, Écosse, Østlandet
- Glasgow, Oslo, Toronto, Toulouse
- Université de Glasgow, Université de Toronto
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Strom</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Department of Pathology, Oslo University Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>7 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Jardine, Alan" sort="Jardine, Alan" uniqKey="Jardine A" first="Alan" last="Jardine">Alan Jardine</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Glasgow Cardiovascular Research Centre, Faculty of Medicine, University of Glasgow</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName><orgName type="university">Université de Glasgow</orgName></affiliation></author><author><name sortKey="Midtvedt, Karsten" sort="Midtvedt, Karsten" uniqKey="Midtvedt K" first="Karsten" last="Midtvedt">Karsten Midtvedt</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Department of Nephrology, Medical Department, Rikshospitalet, Oslo University Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>9 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Machein, Uwe" sort="Machein, Uwe" uniqKey="Machein U" first="Uwe" last="Machein">Uwe Machein</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author><author><name sortKey="Ulbricht, Bettina" sort="Ulbricht, Bettina" uniqKey="Ulbricht B" first="Bettina" last="Ulbricht">Bettina Ulbricht</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author><author><name sortKey="Karpov, Alexander" sort="Karpov, Alexander" uniqKey="Karpov A" first="Alexander" last="Karpov">Alexander Karpov</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author><author><name sortKey="O Connell, Philip J" sort="O Connell, Philip J" uniqKey="O Connell P" first="Philip J." last="O'Connell">Philip J. O'Connell</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Centre for Transplant and Renal Research, Westmead Millennium Institute, University of Sydney at Westmead Hospital</s1><s2>New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>New South Wales</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">11-0381950</idno><date when="2011">2011</date><idno type="stanalyst">PASCAL 11-0381950 INIST</idno><idno type="RBID">Pascal:11-0381950</idno><idno type="wicri:Area/PascalFrancis/Corpus">001A20</idno><idno type="wicri:Area/PascalFrancis/Curation">004524</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001C34</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001C34</idno><idno type="wicri:doubleKey">0041-1337:2011:Holdaas H:conversion:of:long</idno><idno type="wicri:Area/Main/Merge">007085</idno><idno type="wicri:Area/Main/Curation">006C28</idno><idno type="wicri:Area/Main/Exploration">006C28</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Conversion of Long-Term Kidney Transplant Recipients From Calcineurin Inhibitor Therapy to Everolimus: A Randomized, Multicenter, 24-Month Study</title><author><name sortKey="Holdaas, Hallvard" sort="Holdaas, Hallvard" uniqKey="Holdaas H" first="Hallvard" last="Holdaas">Hallvard Holdaas</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Medical Department, Rikshospitalet, University of Oslo</s1><s2>Oslo</s2><s3>NOR</s3><sZ>1 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name><affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Seron, Daniel" sort="Seron, Daniel" uniqKey="Seron D" first="Daniel" last="Seron">Daniel Seron</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Nephrology Department, Hospital Vall d'Hebron, Universitat Autonoma Barcelona</s1><s3>ESP</s3><sZ>3 aut.</sZ></inist:fA14><country>Espagne</country><wicri:noRegion>Nephrology Department, Hospital Vall d'Hebron, Universitat Autonoma Barcelona</wicri:noRegion></affiliation></author><author><name sortKey="Cole, Edward" sort="Cole, Edward" uniqKey="Cole E" first="Edward" last="Cole">Edward Cole</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Division of Nephrology, University of Toronto, Toronto General Hospital</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Toronto, Ontario</wicri:noRegion><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Chapman, Jeremy" sort="Chapman, Jeremy" uniqKey="Chapman J" first="Jeremy" last="Chapman">Jeremy Chapman</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Centre for Transplant and Renal Research, Westmead Millennium Institute, University of Sydney at Westmead Hospital</s1><s2>New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>New South Wales</wicri:noRegion></affiliation></author><author><name sortKey="Fellstr M, Bengt" sort="Fellstr M, Bengt" uniqKey="Fellstr M B" first="Bengt" last="Fellstr M">Bengt Fellstr M</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Medical Science, Renal Unit, University Hospital</s1><s2>Uppsala</s2><s3>SWE</s3><sZ>6 aut.</sZ></inist:fA14><country>Suède</country><wicri:noRegion>Uppsala</wicri:noRegion></affiliation></author><author><name sortKey="Strom, Erik H" sort="Strom, Erik H" uniqKey="Strom E" first="Erik H." last="Strom">Erik H. Strom</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Department of Pathology, Oslo University Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>7 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Jardine, Alan" sort="Jardine, Alan" uniqKey="Jardine A" first="Alan" last="Jardine">Alan Jardine</name><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Glasgow Cardiovascular Research Centre, Faculty of Medicine, University of Glasgow</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName><orgName type="university">Université de Glasgow</orgName></affiliation></author><author><name sortKey="Midtvedt, Karsten" sort="Midtvedt, Karsten" uniqKey="Midtvedt K" first="Karsten" last="Midtvedt">Karsten Midtvedt</name><affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Department of Nephrology, Medical Department, Rikshospitalet, Oslo University Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>9 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Machein, Uwe" sort="Machein, Uwe" uniqKey="Machein U" first="Uwe" last="Machein">Uwe Machein</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author><author><name sortKey="Ulbricht, Bettina" sort="Ulbricht, Bettina" uniqKey="Ulbricht B" first="Bettina" last="Ulbricht">Bettina Ulbricht</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author><author><name sortKey="Karpov, Alexander" sort="Karpov, Alexander" uniqKey="Karpov A" first="Alexander" last="Karpov">Alexander Karpov</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ><sZ>12 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author><author><name sortKey="O Connell, Philip J" sort="O Connell, Philip J" uniqKey="O Connell P" first="Philip J." last="O'Connell">Philip J. O'Connell</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Centre for Transplant and Renal Research, Westmead Millennium Institute, University of Sydney at Westmead Hospital</s1><s2>New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>13 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>New South Wales</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Transplantation</title><title level="j" type="abbreviated">Transplantation</title><idno type="ISSN">0041-1337</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Transplantation</title><title level="j" type="abbreviated">Transplantation</title><idno type="ISSN">0041-1337</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antibacterial agent</term><term>Calcineurin inhibitor</term><term>Clinical trial</term><term>Conversion</term><term>Drug conversion</term><term>Everolimus</term><term>Graft</term><term>Homotransplantation</term><term>Immunosuppressive agent</term><term>Kidney</term><term>Long term</term><term>Multicenter study</term><term>Randomization</term><term>Transplantation</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Homotransplantation</term><term>Conversion</term><term>Changement médicament</term><term>Inhibiteur de la calcineurine</term><term>Long terme</term><term>Transplantation</term><term>Evérolimus</term><term>Rein</term><term>Traitement</term><term>Immunodépresseur</term><term>Randomisation</term><term>Essai clinique</term><term>Etude multicentrique</term><term>Greffe</term><term>Antibactérien</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background. Benefits of conversion from calcineurin inhibitor (CNI) to mammalian target of rapamycin inhibitor-based immunosuppression in long-term kidney transplant patients remain uncertain. Methods. ASCERTAIN was a 24-month, open-label, multicenter study. Kidney transplant patients more than 6 months posttransplant receiving CNI (baseline glomerular filtration rate [GFR] 30-70 mL/min/1.73 m<sup>2</sup>) were randomized to everolimus with CNI elimination (n= 127) or CNI minimization (n= 144), or continued CNI unchanged (controls, n= 123) to assess the effect on measured GFR at month 24 after randomization. Results. Renal function was stable in all groups to month 24. Mean measured GFR at month 24, the primary endpoint, was 48.0±22.0 mL/min/1.73 m<sup>2</sup>, 46.6±21.1 mL/min/1.73 m<sup>2</sup>, and 46.0±20.4 mL/min/1.73 m<sup>2</sup> in the CNI elimination, CNI minimization, and control groups, respectively. Differences between CNI elimination (1.12 mL/min/1.73 m<sup>2</sup>, 95% confidence interval [CI] -3.51 to 5.76, P=0.63) and CNI minimization (0.59 mL/min/1.73 m<sup>2</sup>, 95% CI -3.88 to 5.07, P=0.79) versus controls at month 24 were nonsignificant that is, the primary endpoint was not met. No efficacy endpoint differed significantly between groups. Post hoc analyses showed that patients with baseline creatinine clearance (CrCl) more than 50 mL/min had a significantly greater increase in measured GFR after CNI elimination versus controls (difference 11.4 mL/min/1.73 m<sup>2</sup>, 95% CI 2.1 to 20.8 mL/min/1.73 m<sup>2</sup>, P=0.017). Adverse events resulted in discontinuation in 36 (28.3%) CNI elimination patients, 24 (16.7%) CNI minimization patients, and 5 (4.1%) controls (P<0.001 vs. CNI elimination; P=0.020 vs. CNI minimization). Conclusion. Conversion to everolimus with CNI elimination or minimization a mean of 5.6 years after kidney transplantation had no overall renal benefit and was associated with more frequent adverse events and discontinuations. Patients with CrCl more than 50 mL/min may benefit from a change in therapy more than 6 months after renal transplantation.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Norvège</li><li>Royaume-Uni</li><li>Suisse</li><li>Suède</li></country><region><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Ontario</li><li>Écosse</li><li>Østlandet</li></region><settlement><li>Glasgow</li><li>Oslo</li><li>Toronto</li><li>Toulouse</li></settlement><orgName><li>Université de Glasgow</li><li>Université de Toronto</li></orgName></list><tree><country name="Norvège"><region name="Østlandet"><name sortKey="Holdaas, Hallvard" sort="Holdaas, Hallvard" uniqKey="Holdaas H" first="Hallvard" last="Holdaas">Hallvard Holdaas</name></region><name sortKey="Midtvedt, Karsten" sort="Midtvedt, Karsten" uniqKey="Midtvedt K" first="Karsten" last="Midtvedt">Karsten Midtvedt</name><name sortKey="Strom, Erik H" sort="Strom, Erik H" uniqKey="Strom E" first="Erik H." last="Strom">Erik H. Strom</name></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Rostaing, Lionel" sort="Rostaing, Lionel" uniqKey="Rostaing L" first="Lionel" last="Rostaing">Lionel Rostaing</name></region></country><country name="Espagne"><noRegion><name sortKey="Seron, Daniel" sort="Seron, Daniel" uniqKey="Seron D" first="Daniel" last="Seron">Daniel Seron</name></noRegion></country><country name="Canada"><region name="Ontario"><name sortKey="Cole, Edward" sort="Cole, Edward" uniqKey="Cole E" first="Edward" last="Cole">Edward Cole</name></region></country><country name="Australie"><noRegion><name sortKey="Chapman, Jeremy" sort="Chapman, Jeremy" uniqKey="Chapman J" first="Jeremy" last="Chapman">Jeremy Chapman</name></noRegion><name sortKey="O Connell, Philip J" sort="O Connell, Philip J" uniqKey="O Connell P" first="Philip J." last="O'Connell">Philip J. 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