Mechanistic analyses in kidney transplant recipients prospectively randomized to two steroid free regimen-Low dose Tacrolimus with Everolimus versus standard dose Tacrolimus with Mycophenolate Mofetil.
Identifieur interne : 000287 ( Main/Exploration ); précédent : 000286; suivant : 000288Mechanistic analyses in kidney transplant recipients prospectively randomized to two steroid free regimen-Low dose Tacrolimus with Everolimus versus standard dose Tacrolimus with Mycophenolate Mofetil.
Auteurs : Opas Traitanon [États-Unis, Thaïlande] ; James M. Mathew [États-Unis] ; Aneesha Shetty [États-Unis] ; Sai Vineela Bontha [États-Unis] ; Daniel G. Maluf [États-Unis] ; Yvonne El Kassis [États-Unis] ; Sook H. Park [États-Unis] ; Jing Han [États-Unis] ; M Javeed Ansari [États-Unis] ; Joseph R. Leventhal [États-Unis] ; Valeria Mas [États-Unis] ; Lorenzo Gallon [États-Unis]Source :
- PloS one [ 1932-6203 ] ; 2019.
Descripteurs français
- KwdFr :
- Acide mycophénolique (administration et posologie), Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Association de médicaments (méthodes), Femelle (MeSH), Humains (MeSH), Immunosuppresseurs (administration et posologie), Immunosuppresseurs (pharmacologie), Jeune adulte (MeSH), Mâle (MeSH), Receveurs de transplantation (MeSH), Rejet du greffon (prévention et contrôle), Résultat thérapeutique (MeSH), Survie du greffon (effets des médicaments et des substances chimiques), Tacrolimus (administration et posologie), Transplantation rénale (méthodes), Évérolimus (administration et posologie).
- MESH :
- administration et posologie : Acide mycophénolique, Immunosuppresseurs, Tacrolimus, Évérolimus.
- effets des médicaments et des substances chimiques : Survie du greffon.
- méthodes : Association de médicaments, Transplantation rénale.
- pharmacologie : Immunosuppresseurs.
- prévention et contrôle : Rejet du greffon.
- Adolescent, Adulte, Adulte d'âge moyen, Femelle, Humains, Jeune adulte, Mâle, Receveurs de transplantation, Résultat thérapeutique.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Drug Therapy, Combination (methods), Everolimus (administration & dosage), Female (MeSH), Graft Rejection (prevention & control), Graft Survival (drug effects), Humans (MeSH), Immunosuppressive Agents (administration & dosage), Immunosuppressive Agents (pharmacology), Kidney Transplantation (methods), Male (MeSH), Middle Aged (MeSH), Mycophenolic Acid (administration & dosage), Tacrolimus (administration & dosage), Transplant Recipients (MeSH), Treatment Outcome (MeSH), Young Adult (MeSH).
- MESH :
- chemical , administration & dosage : Everolimus, Immunosuppressive Agents, Mycophenolic Acid, Tacrolimus.
- drug effects : Graft Survival.
- methods : Drug Therapy, Combination, Kidney Transplantation.
- chemical , pharmacology : Immunosuppressive Agents.
- prevention & control : Graft Rejection.
- Adolescent, Adult, Female, Humans, Male, Middle Aged, Transplant Recipients, Treatment Outcome, Young Adult.
Abstract
Calcineurin inhibitors (CNI), the cornerstone of immunosuppression after transplantation are implicated in nephrotoxicity and allograft dysfunction. We hypothesized that combined low doses of CNI and Everolimus (EVR) may result in better graft outcomes and greater tolerogenic milieu. Forty adult renal transplant recipients were prospectively randomized to (steroid free) low dose Tacrolimus (TAC) and EVR or standard dose TAC and Mycophenolate (MMF) after Alemtuzumab induction. Baseline characteristics were statistically similar. EVR levels were maintained at 3-8 ng/ml. TAC levels were 4.5±1.9 and 6.4±1.5 ng/ml in the TAC+EVR and TAC+MMF group respectively. Follow up was 14±4 and 17±5 months respectively and included protocol kidney biopsies at 3 and 12 months post-transplantation. Rejection-rate was lower in the TAC+EVR group. However patient and overall graft survival, eGFR and incidence of adverse events were similar. TAC+EVR induced expansion of CD4+CD25hiFoxp3+ regulatory T cells as early as 3 months and expansion of IFN-γ+CD4+CD25hiFoxp3+ regulatory T cells at 12 months post-transplant. Gene expression profile showed a trend toward decreased inflammation, angiogenesis and connective tissue growth in the TAC+EVR Group. Thus, greater tolerogenic mechanisms were found to be operating in patients with low dose TAC+EVR and this might be responsible for the lower rejection-rate than in patients on standard dose TAC+MMF. However, further studies with longer follow up and evaluating impact on T regulatory cells are warranted.
DOI: 10.1371/journal.pone.0216300
PubMed: 31136582
PubMed Central: PMC6538151
Affiliations:
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Park</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Han, Jing" sort="Han, Jing" uniqKey="Han J" first="Jing" last="Han">Jing Han</name><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Ansari, M Javeed" sort="Ansari, M Javeed" uniqKey="Ansari M" first="M Javeed" last="Ansari">M Javeed Ansari</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Leventhal, Joseph R" sort="Leventhal, Joseph R" uniqKey="Leventhal J" first="Joseph R" last="Leventhal">Joseph R. Leventhal</name><affiliation wicri:level="2"><nlm:affiliation>Department of Surgery, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Mas, Valeria" sort="Mas, Valeria" uniqKey="Mas V" first="Valeria" last="Mas">Valeria Mas</name><affiliation wicri:level="2"><nlm:affiliation>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Gallon, Lorenzo" sort="Gallon, Lorenzo" uniqKey="Gallon L" first="Lorenzo" last="Gallon">Lorenzo Gallon</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2019">2019</date><idno type="RBID">pubmed:31136582</idno><idno type="pmid">31136582</idno><idno type="doi">10.1371/journal.pone.0216300</idno><idno type="pmc">PMC6538151</idno><idno type="wicri:Area/Main/Corpus">000266</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000266</idno><idno type="wicri:Area/Main/Curation">000266</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000266</idno><idno type="wicri:Area/Main/Exploration">000266</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Mechanistic analyses in kidney transplant recipients prospectively randomized to two steroid free regimen-Low dose Tacrolimus with Everolimus versus standard dose Tacrolimus with Mycophenolate Mofetil.</title><author><name sortKey="Traitanon, Opas" sort="Traitanon, Opas" uniqKey="Traitanon O" first="Opas" last="Traitanon">Opas Traitanon</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine-Nephrology, Thammasart University Hospital, Pathumthani, Thailand.</nlm:affiliation><country xml:lang="fr">Thaïlande</country><wicri:regionArea>Department of Medicine-Nephrology, Thammasart University Hospital, Pathumthani</wicri:regionArea><wicri:noRegion>Pathumthani</wicri:noRegion></affiliation></author><author><name sortKey="Mathew, James M" sort="Mathew, James M" uniqKey="Mathew J" first="James M" last="Mathew">James M. Mathew</name><affiliation wicri:level="2"><nlm:affiliation>Department of Surgery, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Department of Microbiology-Immunology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Microbiology-Immunology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Shetty, Aneesha" sort="Shetty, Aneesha" uniqKey="Shetty A" first="Aneesha" last="Shetty">Aneesha Shetty</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Bontha, Sai Vineela" sort="Bontha, Sai Vineela" uniqKey="Bontha S" first="Sai Vineela" last="Bontha">Sai Vineela Bontha</name><affiliation wicri:level="2"><nlm:affiliation>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Maluf, Daniel G" sort="Maluf, Daniel G" uniqKey="Maluf D" first="Daniel G" last="Maluf">Daniel G. Maluf</name><affiliation wicri:level="2"><nlm:affiliation>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="El Kassis, Yvonne" sort="El Kassis, Yvonne" uniqKey="El Kassis Y" first="Yvonne" last="El Kassis">Yvonne El Kassis</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Park, Sook H" sort="Park, Sook H" uniqKey="Park S" first="Sook H" last="Park">Sook H. Park</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Han, Jing" sort="Han, Jing" uniqKey="Han J" first="Jing" last="Han">Jing Han</name><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Ansari, M Javeed" sort="Ansari, M Javeed" uniqKey="Ansari M" first="M Javeed" last="Ansari">M Javeed Ansari</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Leventhal, Joseph R" sort="Leventhal, Joseph R" uniqKey="Leventhal J" first="Joseph R" last="Leventhal">Joseph R. Leventhal</name><affiliation wicri:level="2"><nlm:affiliation>Department of Surgery, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Surgery, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author><author><name sortKey="Mas, Valeria" sort="Mas, Valeria" uniqKey="Mas V" first="Valeria" last="Mas">Valeria Mas</name><affiliation wicri:level="2"><nlm:affiliation>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN</wicri:regionArea><placeName><region type="state">Tennessee</region></placeName></affiliation></author><author><name sortKey="Gallon, Lorenzo" sort="Gallon, Lorenzo" uniqKey="Gallon L" first="Lorenzo" last="Gallon">Lorenzo Gallon</name><affiliation wicri:level="2"><nlm:affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine-Nephrology, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Comprehensive Transplant Center, Northwestern University, Chicago, IL</wicri:regionArea><placeName><region type="state">Illinois</region></placeName></affiliation></author></analytic><series><title level="j">PloS one</title><idno type="eISSN">1932-6203</idno><imprint><date when="2019" type="published">2019</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Drug Therapy, Combination (methods)</term><term>Everolimus (administration & dosage)</term><term>Female (MeSH)</term><term>Graft Rejection (prevention & control)</term><term>Graft Survival (drug effects)</term><term>Humans (MeSH)</term><term>Immunosuppressive Agents (administration & dosage)</term><term>Immunosuppressive Agents (pharmacology)</term><term>Kidney Transplantation (methods)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Mycophenolic Acid (administration & dosage)</term><term>Tacrolimus (administration & dosage)</term><term>Transplant Recipients (MeSH)</term><term>Treatment Outcome (MeSH)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Acide mycophénolique (administration et posologie)</term><term>Adolescent (MeSH)</term><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Association de médicaments (méthodes)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Immunosuppresseurs (administration et posologie)</term><term>Immunosuppresseurs (pharmacologie)</term><term>Jeune adulte (MeSH)</term><term>Mâle (MeSH)</term><term>Receveurs de transplantation (MeSH)</term><term>Rejet du greffon (prévention et contrôle)</term><term>Résultat thérapeutique (MeSH)</term><term>Survie du greffon (effets des médicaments et des substances chimiques)</term><term>Tacrolimus (administration et posologie)</term><term>Transplantation rénale (méthodes)</term><term>Évérolimus (administration et posologie)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Everolimus</term><term>Immunosuppressive Agents</term><term>Mycophenolic Acid</term><term>Tacrolimus</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Acide mycophénolique</term><term>Immunosuppresseurs</term><term>Tacrolimus</term><term>Évérolimus</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Graft Survival</term></keywords><keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Survie du greffon</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Drug Therapy, Combination</term><term>Kidney Transplantation</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Association de médicaments</term><term>Transplantation rénale</term></keywords><keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Immunosuppresseurs</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Immunosuppressive Agents</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Graft Rejection</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Rejet du greffon</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Transplant Recipients</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Jeune adulte</term><term>Mâle</term><term>Receveurs de transplantation</term><term>Résultat thérapeutique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Calcineurin inhibitors (CNI), the cornerstone of immunosuppression after transplantation are implicated in nephrotoxicity and allograft dysfunction. We hypothesized that combined low doses of CNI and Everolimus (EVR) may result in better graft outcomes and greater tolerogenic milieu. Forty adult renal transplant recipients were prospectively randomized to (steroid free) low dose Tacrolimus (TAC) and EVR or standard dose TAC and Mycophenolate (MMF) after Alemtuzumab induction. Baseline characteristics were statistically similar. EVR levels were maintained at 3-8 ng/ml. TAC levels were 4.5±1.9 and 6.4±1.5 ng/ml in the TAC+EVR and TAC+MMF group respectively. Follow up was 14±4 and 17±5 months respectively and included protocol kidney biopsies at 3 and 12 months post-transplantation. Rejection-rate was lower in the TAC+EVR group. However patient and overall graft survival, eGFR and incidence of adverse events were similar. TAC+EVR induced expansion of CD4+CD25hiFoxp3+ regulatory T cells as early as 3 months and expansion of IFN-γ+CD4+CD25hiFoxp3+ regulatory T cells at 12 months post-transplant. Gene expression profile showed a trend toward decreased inflammation, angiogenesis and connective tissue growth in the TAC+EVR Group. Thus, greater tolerogenic mechanisms were found to be operating in patients with low dose TAC+EVR and this might be responsible for the lower rejection-rate than in patients on standard dose TAC+MMF. However, further studies with longer follow up and evaluating impact on T regulatory cells are warranted.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">31136582</PMID><DateCompleted><Year>2020</Year><Month>01</Month><Day>27</Day></DateCompleted><DateRevised><Year>2020</Year><Month>03</Month><Day>09</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN><JournalIssue CitedMedium="Internet"><Volume>14</Volume><Issue>5</Issue><PubDate><Year>2019</Year></PubDate></JournalIssue><Title>PloS one</Title><ISOAbbreviation>PLoS One</ISOAbbreviation></Journal><ArticleTitle>Mechanistic analyses in kidney transplant recipients prospectively randomized to two steroid free regimen-Low dose Tacrolimus with Everolimus versus standard dose Tacrolimus with Mycophenolate Mofetil.</ArticleTitle><Pagination><MedlinePgn>e0216300</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1371/journal.pone.0216300</ELocationID><Abstract><AbstractText>Calcineurin inhibitors (CNI), the cornerstone of immunosuppression after transplantation are implicated in nephrotoxicity and allograft dysfunction. We hypothesized that combined low doses of CNI and Everolimus (EVR) may result in better graft outcomes and greater tolerogenic milieu. Forty adult renal transplant recipients were prospectively randomized to (steroid free) low dose Tacrolimus (TAC) and EVR or standard dose TAC and Mycophenolate (MMF) after Alemtuzumab induction. Baseline characteristics were statistically similar. EVR levels were maintained at 3-8 ng/ml. TAC levels were 4.5±1.9 and 6.4±1.5 ng/ml in the TAC+EVR and TAC+MMF group respectively. Follow up was 14±4 and 17±5 months respectively and included protocol kidney biopsies at 3 and 12 months post-transplantation. Rejection-rate was lower in the TAC+EVR group. However patient and overall graft survival, eGFR and incidence of adverse events were similar. TAC+EVR induced expansion of CD4+CD25hiFoxp3+ regulatory T cells as early as 3 months and expansion of IFN-γ+CD4+CD25hiFoxp3+ regulatory T cells at 12 months post-transplant. Gene expression profile showed a trend toward decreased inflammation, angiogenesis and connective tissue growth in the TAC+EVR Group. Thus, greater tolerogenic mechanisms were found to be operating in patients with low dose TAC+EVR and this might be responsible for the lower rejection-rate than in patients on standard dose TAC+MMF. However, further studies with longer follow up and evaluating impact on T regulatory cells are warranted.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Traitanon</LastName><ForeName>Opas</ForeName><Initials>O</Initials><AffiliationInfo><Affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Medicine-Nephrology, Thammasart University Hospital, Pathumthani, Thailand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mathew</LastName><ForeName>James M</ForeName><Initials>JM</Initials><Identifier Source="ORCID">0000-0002-5667-750X</Identifier><AffiliationInfo><Affiliation>Department of Surgery, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Microbiology-Immunology, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shetty</LastName><ForeName>Aneesha</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bontha</LastName><ForeName>Sai Vineela</ForeName><Initials>SV</Initials><AffiliationInfo><Affiliation>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maluf</LastName><ForeName>Daniel G</ForeName><Initials>DG</Initials><AffiliationInfo><Affiliation>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>El Kassis</LastName><ForeName>Yvonne</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Park</LastName><ForeName>Sook H</ForeName><Initials>SH</Initials><AffiliationInfo><Affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Han</LastName><ForeName>Jing</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ansari</LastName><ForeName>M Javeed</ForeName><Initials>MJ</Initials><AffiliationInfo><Affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leventhal</LastName><ForeName>Joseph R</ForeName><Initials>JR</Initials><AffiliationInfo><Affiliation>Department of Surgery, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mas</LastName><ForeName>Valeria</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Methodist University Transplant Institute; University of Tennessee Health Science Center; Memphis, TN, United States of America.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gallon</LastName><ForeName>Lorenzo</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Medicine-Nephrology, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Comprehensive Transplant Center, Northwestern University, Chicago, IL, United States of America.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>T32 DK108738</GrantID><Acronym>DK</Acronym><Agency>NIDDK NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2019</Year><Month>05</Month><Day>28</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>PLoS One</MedlineTA><NlmUniqueID>101285081</NlmUniqueID><ISSNLinking>1932-6203</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007166">Immunosuppressive Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>9HW64Q8G6G</RegistryNumber><NameOfSubstance UI="D000068338">Everolimus</NameOfSubstance></Chemical><Chemical><RegistryNumber>HU9DX48N0T</RegistryNumber><NameOfSubstance UI="D009173">Mycophenolic Acid</NameOfSubstance></Chemical><Chemical><RegistryNumber>WM0HAQ4WNM</RegistryNumber><NameOfSubstance UI="D016559">Tacrolimus</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000068338" MajorTopicYN="N">Everolimus</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006084" MajorTopicYN="N">Graft Rejection</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006085" MajorTopicYN="N">Graft Survival</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007166" MajorTopicYN="N">Immunosuppressive Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016030" MajorTopicYN="N">Kidney Transplantation</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009173" MajorTopicYN="N">Mycophenolic Acid</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016559" MajorTopicYN="N">Tacrolimus</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D066027" MajorTopicYN="N">Transplant Recipients</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><CoiStatement>The authors have declared that no competing interests exist.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2019</Year><Month>01</Month><Day>29</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2019</Year><Month>04</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2019</Year><Month>5</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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last="Ansari">M Javeed Ansari</name><name sortKey="Ansari, M Javeed" sort="Ansari, M Javeed" uniqKey="Ansari M" first="M Javeed" last="Ansari">M Javeed Ansari</name><name sortKey="Bontha, Sai Vineela" sort="Bontha, Sai Vineela" uniqKey="Bontha S" first="Sai Vineela" last="Bontha">Sai Vineela Bontha</name><name sortKey="El Kassis, Yvonne" sort="El Kassis, Yvonne" uniqKey="El Kassis Y" first="Yvonne" last="El Kassis">Yvonne El Kassis</name><name sortKey="Gallon, Lorenzo" sort="Gallon, Lorenzo" uniqKey="Gallon L" first="Lorenzo" last="Gallon">Lorenzo Gallon</name><name sortKey="Gallon, Lorenzo" sort="Gallon, Lorenzo" uniqKey="Gallon L" first="Lorenzo" last="Gallon">Lorenzo Gallon</name><name sortKey="Han, Jing" sort="Han, Jing" uniqKey="Han J" first="Jing" last="Han">Jing Han</name><name sortKey="Leventhal, Joseph R" sort="Leventhal, Joseph R" uniqKey="Leventhal J" first="Joseph R" last="Leventhal">Joseph R. Leventhal</name><name sortKey="Leventhal, Joseph R" sort="Leventhal, Joseph R" uniqKey="Leventhal J" first="Joseph R" last="Leventhal">Joseph R. Leventhal</name><name sortKey="Maluf, Daniel G" sort="Maluf, Daniel G" uniqKey="Maluf D" first="Daniel G" last="Maluf">Daniel G. Maluf</name><name sortKey="Mas, Valeria" sort="Mas, Valeria" uniqKey="Mas V" first="Valeria" last="Mas">Valeria Mas</name><name sortKey="Mathew, James M" sort="Mathew, James M" uniqKey="Mathew J" first="James M" last="Mathew">James M. Mathew</name><name sortKey="Mathew, James M" sort="Mathew, James M" uniqKey="Mathew J" first="James M" last="Mathew">James M. Mathew</name><name sortKey="Mathew, James M" sort="Mathew, James M" uniqKey="Mathew J" first="James M" last="Mathew">James M. Mathew</name><name sortKey="Park, Sook H" sort="Park, Sook H" uniqKey="Park S" first="Sook H" last="Park">Sook H. Park</name><name sortKey="Shetty, Aneesha" sort="Shetty, Aneesha" uniqKey="Shetty A" first="Aneesha" last="Shetty">Aneesha Shetty</name></country><country name="Thaïlande"><noRegion><name sortKey="Traitanon, Opas" sort="Traitanon, Opas" uniqKey="Traitanon O" first="Opas" last="Traitanon">Opas Traitanon</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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