Clinical Trials for Immunosuppression in Transplantation: The Case for Reform and Change in Direction.
Identifieur interne : 000F89 ( Main/Exploration ); précédent : 000F88; suivant : 000F90Clinical Trials for Immunosuppression in Transplantation: The Case for Reform and Change in Direction.
Auteurs : Philip J. O Connell [États-Unis] ; Dirk R. Kuypers ; Roslyn B. Mannon ; Michael Abecassis ; Stephen J. Chadban ; John S. Gill ; Barbara Murphy ; Peter W. Nickerson ; Jesse D. Schold ; Peter G. Stock ; Daniel Seron ; Rita R. Alloway ; Jonathan S. Bromberg ; Klemens Budde ; Stanley C. Jordan ; Christophe Legendre ; Carmen Lefaucheur ; Minnie Sarwall ; Dorry L. Segev ; Mark D. Stegall ; Stefan G. Tullius ; Germaine Wong ; E Steve Woodle ; Nancy Ascher ; Randall E. MorrisSource :
- Transplantation [ 1534-6080 ] ; 2017.
Descripteurs français
- KwdFr :
- Essais cliniques comme sujet (), Facteurs de risque, Facteurs temps, Histocompatibilité, Humains, Immunosuppresseurs (effets indésirables), Immunosuppresseurs (usage thérapeutique), Maladie aigüe, Maladie chronique, Maladies du rein (), Maladies du rein (diagnostic), Maladies du rein (psychologie), Plan de recherche (tendances), Qualité de vie, Rejet du greffon (), Rejet du greffon (immunologie), Résultat thérapeutique, Survie du greffon, Sélection de donneurs, Sélection de patients, Transplantation rénale (effets indésirables), Évaluation des risques.
- MESH :
- diagnostic : Maladies du rein.
- effets indésirables : Immunosuppresseurs, Transplantation rénale.
- immunologie : Rejet du greffon.
- psychologie : Maladies du rein.
- tendances : Plan de recherche.
- usage thérapeutique : Immunosuppresseurs.
- Essais cliniques comme sujet, Facteurs de risque, Facteurs temps, Histocompatibilité, Humains, Maladie aigüe, Maladie chronique, Maladies du rein, Qualité de vie, Rejet du greffon, Résultat thérapeutique, Survie du greffon, Sélection de donneurs, Sélection de patients, Évaluation des risques.
English descriptors
- KwdEn :
- Acute Disease, Chronic Disease, Clinical Trials as Topic (methods), Donor Selection, Graft Rejection (immunology), Graft Rejection (prevention & control), Graft Survival, Histocompatibility, Humans, Immunosuppressive Agents (adverse effects), Immunosuppressive Agents (therapeutic use), Kidney Diseases (diagnosis), Kidney Diseases (psychology), Kidney Diseases (surgery), Kidney Transplantation (adverse effects), Patient Selection, Quality of Life, Research Design (trends), Risk Assessment, Risk Factors, Time Factors, Treatment Outcome.
- MESH :
- chemical , adverse effects : Immunosuppressive Agents.
- adverse effects : Kidney Transplantation.
- diagnosis : Kidney Diseases.
- immunology : Graft Rejection.
- methods : Clinical Trials as Topic.
- prevention & control : Graft Rejection.
- psychology : Kidney Diseases.
- surgery : Kidney Diseases.
- chemical , therapeutic use : Immunosuppressive Agents.
- trends : Research Design.
- Acute Disease, Chronic Disease, Donor Selection, Graft Survival, Histocompatibility, Humans, Patient Selection, Quality of Life, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome.
Abstract
Currently trials of immunosuppression in transplantation are in decline because their objectives remain focused on improving acute rejection rates and graft survival in the first 12 months. With 1 year renal graft survival rates of greater than 90% the best that can be hoped for is noninferiority trial outcomes compared with current standard of care. Current trial design is not leading to novel therapies improving long-term outcomes and safety, and hence important unmet clinical needs in transplantation remain unanswered. Issues that need to be addressed include but are not limited to: prevention of subclinical rejection in the first year, better 5- and 10-year graft outcomes, more effective treatment for high immunological risk and sensitized (including donor-specific antibody) patients, immunosuppressive combinations that are better tolerated by patients with fewer side effects and less morbidity and mortality. In September 2015, the Transplantation Society convened a group of transplant clinical trial experts to address these problems. The aims were to substantially realign the priorities of clinical trials for renal transplant immunosuppression with the current unmet needs and to propose new designs for clinical trials for transplant immunosuppression. Moving forward, the transplant community needs to provide trial data that will identify superior treatment options for patient subgroups and allow new agents to be evaluated for efficacy and safety and achieve timely regulatory approval. Trial designs for new transplant immunosuppression must be intelligently restructured to ensure that short- and long-term clinical outcomes continue to improve.
DOI: 10.1097/TP.0000000000001648
PubMed: 28207630
Affiliations:
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Le document en format XML
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O Connell</name><affiliation wicri:level="2"><nlm:affiliation>1 Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney at Westmead Hospital, Sydney, NSW, Australia. 2 Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium. 3 Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL. 4 Division of Organ Transplantation, Feinberg School of Medicine, Northwestern University, Chicago, IL. 5 Department of Renal Medicine, University of Sydney at Royal Prince Alfred Hospital, Australia. 6 The Division of Nephrology, St. Paul's Hospital, Vancouver, British Columbia, Canada. 7 Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 8 Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY. 9 Transplant Immunology Laboratory, University of Manitoba, Winnipeg Blood Centre, Winnipeg, Manitoba, Canada. 10 Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, OH. 11 Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH. 12 Department of Surgery, University of California San Francisco, San Francisco, CA. 13 Department of Nephrology, Hospital Universitari Vall d'Hebron, Universitat Autónoma Barcelona, Barcelona, Spain. 14 Department of Medicine, University of Cincinnati, College of Medicine, Cincinnati, OH. 15 Division of Transplantation, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD. 16 Department of Nephrology, Universitätsklinikum Charité, Humboldt University, Berlin, Germany. 17 The Comprehensive Transplant Center, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA. 18 Service de Néphrologie-Transplantation, Hôpital Necker, Paris, France, Université Paris Descartes, Sorbonne Paris Cité, Paris France. 19 INSERM U845, Hôpital Necker, Paris, France. 20 Department of Nephrology and Kidney Transplantation, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 21 Division of Transplant Surgery, University of California San Francisco, San Francisco, CA. 22 Division of Transplantation, Department of Surgery, The Johns Hopkins University, Baltimore, MD. 23 Departments of Surgery and Immunology, von Liebig Transplant Center, Mayo Clinic, Rochester, MN. 24 Transplant Surgery Division, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 25Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH. 26 Stanford University School of Medicine, Stanford, CA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>1 Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney at Westmead Hospital, Sydney, NSW, Australia. 2 Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium. 3 Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL. 4 Division of Organ Transplantation, Feinberg School of Medicine, Northwestern University, Chicago, IL. 5 Department of Renal Medicine, University of Sydney at Royal Prince Alfred Hospital, Australia. 6 The Division of Nephrology, St. Paul's Hospital, Vancouver, British Columbia, Canada. 7 Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 8 Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY. 9 Transplant Immunology Laboratory, University of Manitoba, Winnipeg Blood Centre, Winnipeg, Manitoba, Canada. 10 Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, OH. 11 Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH. 12 Department of Surgery, University of California San Francisco, San Francisco, CA. 13 Department of Nephrology, Hospital Universitari Vall d'Hebron, Universitat Autónoma Barcelona, Barcelona, Spain. 14 Department of Medicine, University of Cincinnati, College of Medicine, Cincinnati, OH. 15 Division of Transplantation, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD. 16 Department of Nephrology, Universitätsklinikum Charité, Humboldt University, Berlin, Germany. 17 The Comprehensive Transplant Center, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA. 18 Service de Néphrologie-Transplantation, Hôpital Necker, Paris, France, Université Paris Descartes, Sorbonne Paris Cité, Paris France. 19 INSERM U845, Hôpital Necker, Paris, France. 20 Department of Nephrology and Kidney Transplantation, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 21 Division of Transplant Surgery, University of California San Francisco, San Francisco, CA. 22 Division of Transplantation, Department of Surgery, The Johns Hopkins University, Baltimore, MD. 23 Departments of Surgery and Immunology, von Liebig Transplant Center, Mayo Clinic, Rochester, MN. 24 Transplant Surgery Division, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 25Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH. 26 Stanford University School of Medicine, Stanford</wicri:cityArea></affiliation></author><author><name sortKey="Kuypers, Dirk R" sort="Kuypers, Dirk R" uniqKey="Kuypers D" first="Dirk R" last="Kuypers">Dirk R. 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O Connell</name><affiliation wicri:level="2"><nlm:affiliation>1 Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney at Westmead Hospital, Sydney, NSW, Australia. 2 Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium. 3 Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL. 4 Division of Organ Transplantation, Feinberg School of Medicine, Northwestern University, Chicago, IL. 5 Department of Renal Medicine, University of Sydney at Royal Prince Alfred Hospital, Australia. 6 The Division of Nephrology, St. Paul's Hospital, Vancouver, British Columbia, Canada. 7 Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 8 Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY. 9 Transplant Immunology Laboratory, University of Manitoba, Winnipeg Blood Centre, Winnipeg, Manitoba, Canada. 10 Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, OH. 11 Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH. 12 Department of Surgery, University of California San Francisco, San Francisco, CA. 13 Department of Nephrology, Hospital Universitari Vall d'Hebron, Universitat Autónoma Barcelona, Barcelona, Spain. 14 Department of Medicine, University of Cincinnati, College of Medicine, Cincinnati, OH. 15 Division of Transplantation, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD. 16 Department of Nephrology, Universitätsklinikum Charité, Humboldt University, Berlin, Germany. 17 The Comprehensive Transplant Center, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA. 18 Service de Néphrologie-Transplantation, Hôpital Necker, Paris, France, Université Paris Descartes, Sorbonne Paris Cité, Paris France. 19 INSERM U845, Hôpital Necker, Paris, France. 20 Department of Nephrology and Kidney Transplantation, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 21 Division of Transplant Surgery, University of California San Francisco, San Francisco, CA. 22 Division of Transplantation, Department of Surgery, The Johns Hopkins University, Baltimore, MD. 23 Departments of Surgery and Immunology, von Liebig Transplant Center, Mayo Clinic, Rochester, MN. 24 Transplant Surgery Division, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 25Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH. 26 Stanford University School of Medicine, Stanford, CA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>1 Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney at Westmead Hospital, Sydney, NSW, Australia. 2 Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Leuven, Belgium. 3 Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL. 4 Division of Organ Transplantation, Feinberg School of Medicine, Northwestern University, Chicago, IL. 5 Department of Renal Medicine, University of Sydney at Royal Prince Alfred Hospital, Australia. 6 The Division of Nephrology, St. Paul's Hospital, Vancouver, British Columbia, Canada. 7 Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. 8 Division of Nephrology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY. 9 Transplant Immunology Laboratory, University of Manitoba, Winnipeg Blood Centre, Winnipeg, Manitoba, Canada. 10 Department of Nephrology and Hypertension, Cleveland Clinic, Cleveland, OH. 11 Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH. 12 Department of Surgery, University of California San Francisco, San Francisco, CA. 13 Department of Nephrology, Hospital Universitari Vall d'Hebron, Universitat Autónoma Barcelona, Barcelona, Spain. 14 Department of Medicine, University of Cincinnati, College of Medicine, Cincinnati, OH. 15 Division of Transplantation, Department of Surgery, University of Maryland School of Medicine, Baltimore, MD. 16 Department of Nephrology, Universitätsklinikum Charité, Humboldt University, Berlin, Germany. 17 The Comprehensive Transplant Center, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, CA. 18 Service de Néphrologie-Transplantation, Hôpital Necker, Paris, France, Université Paris Descartes, Sorbonne Paris Cité, Paris France. 19 INSERM U845, Hôpital Necker, Paris, France. 20 Department of Nephrology and Kidney Transplantation, Saint-Louis Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 21 Division of Transplant Surgery, University of California San Francisco, San Francisco, CA. 22 Division of Transplantation, Department of Surgery, The Johns Hopkins University, Baltimore, MD. 23 Departments of Surgery and Immunology, von Liebig Transplant Center, Mayo Clinic, Rochester, MN. 24 Transplant Surgery Division, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. 25Division of Transplantation, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH. 26 Stanford University School of Medicine, Stanford</wicri:cityArea></affiliation></author><author><name sortKey="Kuypers, Dirk R" sort="Kuypers, Dirk R" uniqKey="Kuypers D" first="Dirk R" last="Kuypers">Dirk R. Kuypers</name></author><author><name sortKey="Mannon, Roslyn B" sort="Mannon, Roslyn B" uniqKey="Mannon R" first="Roslyn B" last="Mannon">Roslyn B. Mannon</name></author><author><name sortKey="Abecassis, Michael" sort="Abecassis, Michael" uniqKey="Abecassis M" first="Michael" last="Abecassis">Michael Abecassis</name></author><author><name sortKey="Chadban, Stephen J" sort="Chadban, Stephen J" uniqKey="Chadban S" first="Stephen J" last="Chadban">Stephen J. Chadban</name></author><author><name sortKey="Gill, John S" sort="Gill, John S" uniqKey="Gill J" first="John S" last="Gill">John S. Gill</name></author><author><name sortKey="Murphy, Barbara" sort="Murphy, Barbara" uniqKey="Murphy B" first="Barbara" last="Murphy">Barbara Murphy</name></author><author><name sortKey="Nickerson, Peter W" sort="Nickerson, Peter W" uniqKey="Nickerson P" first="Peter W" last="Nickerson">Peter W. Nickerson</name></author><author><name sortKey="Schold, Jesse D" sort="Schold, Jesse D" uniqKey="Schold J" first="Jesse D" last="Schold">Jesse D. Schold</name></author><author><name sortKey="Stock, Peter G" sort="Stock, Peter G" uniqKey="Stock P" first="Peter G" last="Stock">Peter G. Stock</name></author><author><name sortKey="Seron, Daniel" sort="Seron, Daniel" uniqKey="Seron D" first="Daniel" last="Seron">Daniel Seron</name></author><author><name sortKey="Alloway, Rita R" sort="Alloway, Rita R" uniqKey="Alloway R" first="Rita R" last="Alloway">Rita R. Alloway</name></author><author><name sortKey="Bromberg, Jonathan S" sort="Bromberg, Jonathan S" uniqKey="Bromberg J" first="Jonathan S" last="Bromberg">Jonathan S. Bromberg</name></author><author><name sortKey="Budde, Klemens" sort="Budde, Klemens" uniqKey="Budde K" first="Klemens" last="Budde">Klemens Budde</name></author><author><name sortKey="Jordan, Stanley C" sort="Jordan, Stanley C" uniqKey="Jordan S" first="Stanley C" last="Jordan">Stanley C. Jordan</name></author><author><name sortKey="Legendre, Christophe" sort="Legendre, Christophe" uniqKey="Legendre C" first="Christophe" last="Legendre">Christophe Legendre</name></author><author><name sortKey="Lefaucheur, Carmen" sort="Lefaucheur, Carmen" uniqKey="Lefaucheur C" first="Carmen" last="Lefaucheur">Carmen Lefaucheur</name></author><author><name sortKey="Sarwall, Minnie" sort="Sarwall, Minnie" uniqKey="Sarwall M" first="Minnie" last="Sarwall">Minnie Sarwall</name></author><author><name sortKey="Segev, Dorry L" sort="Segev, Dorry L" uniqKey="Segev D" first="Dorry L" last="Segev">Dorry L. Segev</name></author><author><name sortKey="Stegall, Mark D" sort="Stegall, Mark D" uniqKey="Stegall M" first="Mark D" last="Stegall">Mark D. Stegall</name></author><author><name sortKey="Tullius, Stefan G" sort="Tullius, Stefan G" uniqKey="Tullius S" first="Stefan G" last="Tullius">Stefan G. Tullius</name></author><author><name sortKey="Wong, Germaine" sort="Wong, Germaine" uniqKey="Wong G" first="Germaine" last="Wong">Germaine Wong</name></author><author><name sortKey="Woodle, E Steve" sort="Woodle, E Steve" uniqKey="Woodle E" first="E Steve" last="Woodle">E Steve Woodle</name></author><author><name sortKey="Ascher, Nancy" sort="Ascher, Nancy" uniqKey="Ascher N" first="Nancy" last="Ascher">Nancy Ascher</name></author><author><name sortKey="Morris, Randall E" sort="Morris, Randall E" uniqKey="Morris R" first="Randall E" last="Morris">Randall E. Morris</name></author></analytic><series><title level="j">Transplantation</title><idno type="eISSN">1534-6080</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Acute Disease</term><term>Chronic Disease</term><term>Clinical Trials as Topic (methods)</term><term>Donor Selection</term><term>Graft Rejection (immunology)</term><term>Graft Rejection (prevention & control)</term><term>Graft Survival</term><term>Histocompatibility</term><term>Humans</term><term>Immunosuppressive Agents (adverse effects)</term><term>Immunosuppressive Agents (therapeutic use)</term><term>Kidney Diseases (diagnosis)</term><term>Kidney Diseases (psychology)</term><term>Kidney Diseases (surgery)</term><term>Kidney Transplantation (adverse effects)</term><term>Patient Selection</term><term>Quality of Life</term><term>Research Design (trends)</term><term>Risk Assessment</term><term>Risk Factors</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Essais cliniques comme sujet ()</term><term>Facteurs de risque</term><term>Facteurs temps</term><term>Histocompatibilité</term><term>Humains</term><term>Immunosuppresseurs (effets indésirables)</term><term>Immunosuppresseurs (usage thérapeutique)</term><term>Maladie aigüe</term><term>Maladie chronique</term><term>Maladies du rein ()</term><term>Maladies du rein (diagnostic)</term><term>Maladies du rein (psychologie)</term><term>Plan de recherche (tendances)</term><term>Qualité de vie</term><term>Rejet du greffon ()</term><term>Rejet du greffon (immunologie)</term><term>Résultat thérapeutique</term><term>Survie du greffon</term><term>Sélection de donneurs</term><term>Sélection de patients</term><term>Transplantation rénale (effets indésirables)</term><term>Évaluation des risques</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Immunosuppressive Agents</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Kidney Transplantation</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Kidney Diseases</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Maladies du rein</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Immunosuppresseurs</term><term>Transplantation rénale</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Rejet du greffon</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Graft Rejection</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Clinical Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Graft Rejection</term></keywords><keywords scheme="MESH" qualifier="psychologie" xml:lang="fr"><term>Maladies du rein</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Kidney Diseases</term></keywords><keywords scheme="MESH" qualifier="surgery" xml:lang="en"><term>Kidney Diseases</term></keywords><keywords scheme="MESH" qualifier="tendances" xml:lang="fr"><term>Plan de recherche</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Immunosuppressive Agents</term></keywords><keywords scheme="MESH" qualifier="trends" xml:lang="en"><term>Research Design</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Immunosuppresseurs</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Acute Disease</term><term>Chronic Disease</term><term>Donor Selection</term><term>Graft Survival</term><term>Histocompatibility</term><term>Humans</term><term>Patient Selection</term><term>Quality of Life</term><term>Risk Assessment</term><term>Risk Factors</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais cliniques comme sujet</term><term>Facteurs de risque</term><term>Facteurs temps</term><term>Histocompatibilité</term><term>Humains</term><term>Maladie aigüe</term><term>Maladie chronique</term><term>Maladies du rein</term><term>Qualité de vie</term><term>Rejet du greffon</term><term>Résultat thérapeutique</term><term>Survie du greffon</term><term>Sélection de donneurs</term><term>Sélection de patients</term><term>Évaluation des risques</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Currently trials of immunosuppression in transplantation are in decline because their objectives remain focused on improving acute rejection rates and graft survival in the first 12 months. With 1 year renal graft survival rates of greater than 90% the best that can be hoped for is noninferiority trial outcomes compared with current standard of care. Current trial design is not leading to novel therapies improving long-term outcomes and safety, and hence important unmet clinical needs in transplantation remain unanswered. Issues that need to be addressed include but are not limited to: prevention of subclinical rejection in the first year, better 5- and 10-year graft outcomes, more effective treatment for high immunological risk and sensitized (including donor-specific antibody) patients, immunosuppressive combinations that are better tolerated by patients with fewer side effects and less morbidity and mortality. In September 2015, the Transplantation Society convened a group of transplant clinical trial experts to address these problems. The aims were to substantially realign the priorities of clinical trials for renal transplant immunosuppression with the current unmet needs and to propose new designs for clinical trials for transplant immunosuppression. Moving forward, the transplant community needs to provide trial data that will identify superior treatment options for patient subgroups and allow new agents to be evaluated for efficacy and safety and achieve timely regulatory approval. Trial designs for new transplant immunosuppression must be intelligently restructured to ensure that short- and long-term clinical outcomes continue to improve.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li></region></list><tree><noCountry><name sortKey="Abecassis, Michael" sort="Abecassis, Michael" uniqKey="Abecassis M" first="Michael" last="Abecassis">Michael Abecassis</name><name sortKey="Alloway, Rita R" sort="Alloway, Rita R" uniqKey="Alloway R" first="Rita R" last="Alloway">Rita R. Alloway</name><name sortKey="Ascher, Nancy" sort="Ascher, Nancy" uniqKey="Ascher N" first="Nancy" last="Ascher">Nancy Ascher</name><name sortKey="Bromberg, Jonathan S" sort="Bromberg, Jonathan S" uniqKey="Bromberg J" first="Jonathan S" last="Bromberg">Jonathan S. Bromberg</name><name sortKey="Budde, Klemens" sort="Budde, Klemens" uniqKey="Budde K" first="Klemens" last="Budde">Klemens Budde</name><name sortKey="Chadban, Stephen J" sort="Chadban, Stephen J" uniqKey="Chadban S" first="Stephen J" last="Chadban">Stephen J. Chadban</name><name sortKey="Gill, John S" sort="Gill, John S" uniqKey="Gill J" first="John S" last="Gill">John S. Gill</name><name sortKey="Jordan, Stanley C" sort="Jordan, Stanley C" uniqKey="Jordan S" first="Stanley C" last="Jordan">Stanley C. Jordan</name><name sortKey="Kuypers, Dirk R" sort="Kuypers, Dirk R" uniqKey="Kuypers D" first="Dirk R" last="Kuypers">Dirk R. Kuypers</name><name sortKey="Lefaucheur, Carmen" sort="Lefaucheur, Carmen" uniqKey="Lefaucheur C" first="Carmen" last="Lefaucheur">Carmen Lefaucheur</name><name sortKey="Legendre, Christophe" sort="Legendre, Christophe" uniqKey="Legendre C" first="Christophe" last="Legendre">Christophe Legendre</name><name sortKey="Mannon, Roslyn B" sort="Mannon, Roslyn B" uniqKey="Mannon R" first="Roslyn B" last="Mannon">Roslyn B. Mannon</name><name sortKey="Morris, Randall E" sort="Morris, Randall E" uniqKey="Morris R" first="Randall E" last="Morris">Randall E. Morris</name><name sortKey="Murphy, Barbara" sort="Murphy, Barbara" uniqKey="Murphy B" first="Barbara" last="Murphy">Barbara Murphy</name><name sortKey="Nickerson, Peter W" sort="Nickerson, Peter W" uniqKey="Nickerson P" first="Peter W" last="Nickerson">Peter W. Nickerson</name><name sortKey="Sarwall, Minnie" sort="Sarwall, Minnie" uniqKey="Sarwall M" first="Minnie" last="Sarwall">Minnie Sarwall</name><name sortKey="Schold, Jesse D" sort="Schold, Jesse D" uniqKey="Schold J" first="Jesse D" last="Schold">Jesse D. Schold</name><name sortKey="Segev, Dorry L" sort="Segev, Dorry L" uniqKey="Segev D" first="Dorry L" last="Segev">Dorry L. Segev</name><name sortKey="Seron, Daniel" sort="Seron, Daniel" uniqKey="Seron D" first="Daniel" last="Seron">Daniel Seron</name><name sortKey="Stegall, Mark D" sort="Stegall, Mark D" uniqKey="Stegall M" first="Mark D" last="Stegall">Mark D. Stegall</name><name sortKey="Stock, Peter G" sort="Stock, Peter G" uniqKey="Stock P" first="Peter G" last="Stock">Peter G. Stock</name><name sortKey="Tullius, Stefan G" sort="Tullius, Stefan G" uniqKey="Tullius S" first="Stefan G" last="Tullius">Stefan G. Tullius</name><name sortKey="Wong, Germaine" sort="Wong, Germaine" uniqKey="Wong G" first="Germaine" last="Wong">Germaine Wong</name><name sortKey="Woodle, E Steve" sort="Woodle, E Steve" uniqKey="Woodle E" first="E Steve" last="Woodle">E Steve Woodle</name></noCountry><country name="États-Unis"><region name="Californie"><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></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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