A randomized 2×2 factorial trial, part 1: single-dose rabbit antithymocyte globulin induction may improve renal transplantation outcomes.
Identifieur interne : 000E03 ( Main/Corpus ); précédent : 000E02; suivant : 000E04A randomized 2×2 factorial trial, part 1: single-dose rabbit antithymocyte globulin induction may improve renal transplantation outcomes.
Auteurs : R Brian Stevens ; Kirk W. Foster ; Clifford D. Miles ; James T. Lane ; Andre C. Kalil ; Diana F. Florescu ; John P. Sandoz ; Theodore H. Rigley ; Kathleen J. Nielsen ; Jill Y. Skorupa ; Anna M. Kellogg ; Tamer Malik ; Lucile E. WrenshallSource :
- Transplantation [ 1534-6080 ] ; 2015.
English descriptors
- KwdEn :
- Adult (MeSH), Animals (MeSH), Antilymphocyte Serum (administration & dosage), Antilymphocyte Serum (adverse effects), Drug Administration Schedule (MeSH), Drug Therapy, Combination (MeSH), Female (MeSH), Graft Rejection (diagnosis), Graft Rejection (immunology), Graft Rejection (mortality), Graft Rejection (prevention & control), Graft Survival (drug effects), Humans (MeSH), Immunosuppressive Agents (administration & dosage), Immunosuppressive Agents (adverse effects), Kaplan-Meier Estimate (MeSH), Kidney Transplantation (adverse effects), Kidney Transplantation (mortality), Male (MeSH), Middle Aged (MeSH), Multivariate Analysis (MeSH), Mycophenolic Acid (administration & dosage), Mycophenolic Acid (analogs & derivatives), Proportional Hazards Models (MeSH), Rabbits (MeSH), Risk Factors (MeSH), Sirolimus (administration & dosage), Steroids (administration & dosage), Tacrolimus (administration & dosage), Time Factors (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , administration & dosage : Antilymphocyte Serum, Immunosuppressive Agents, Mycophenolic Acid, Sirolimus, Steroids, Tacrolimus.
- chemical , adverse effects : Antilymphocyte Serum, Immunosuppressive Agents.
- adverse effects : Kidney Transplantation.
- chemical , analogs & derivatives : Mycophenolic Acid.
- diagnosis : Graft Rejection.
- drug effects : Graft Survival.
- immunology : Graft Rejection.
- mortality : Graft Rejection, Kidney Transplantation.
- prevention & control : Graft Rejection.
- Adult, Animals, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Multivariate Analysis, Proportional Hazards Models, Rabbits, Risk Factors, Time Factors, Treatment Outcome.
Abstract
BACKGROUND
We conducted a randomized and unblinded 2 × 2 sequential-factorial trial, composed of an induction arm (part 1) comparing single-dose (SD) versus divided-dose rabbit antithymocyte globulin (rATG), and a maintenance arm (part 2) comparing tacrolimus minimization versus withdrawal. We report the long-term safety and efficacy of SD-rATG induction in the context of early steroid withdrawal and tacrolimus minimization or withdrawal.
METHODS
Patients (n=180) received 6 mg/kg rATG, SD or four alternate-day doses (1.5 mg/kg/dose), with early steroid withdrawal and tacrolimus or sirolimus maintenance. After 6 months targeted maintenance levels were tacrolimus, 2 to 4 ng/mL and sirolimus, 4 to 6 ng/mL or, if calcineurin inhibitor-withdrawn, sirolimus 8 to 12 ng/mL with mycophenolate mofetil 2 g two times per day. Primary endpoints were renal function (abbreviated modification of diet in renal disease) and chronic graft histopathology (Banff). Secondary endpoints included patient survival, graft survival, biopsy-proven rejection, and infectious or noninfectious complications.
RESULTS
Follow-up averaged longer than 4 years. Tacrolimus or sirolimus and mycophenolate mofetil exposure was identical between groups. The SD-rATG associated with improved renal function (2-36 months; P<0.001) in deceased donor recipients. The SD-rATG associated with quicker lymphocyte, CD4 T cell, and CD4-CD8 recovery and fewer infections. Cox multivariate hazard modeling showed divided-dose-rATG (P=0.019), deceased donor (P=0.003), serious infection (P=0.0.018), and lower lymphocyte count (P=0.001) associated with increased mortality. Patients with all four covariates showed a 27-fold increased likelihood of death (P=0.00002). Chronic graft histopathology, rejection rates, and death-censored graft survival were not significantly different between groups.
CONCLUSION
The SD-rATG induction improves the 3-year renal function in recipients of deceased donor kidneys. This benefit, along with possibly improved patient survival and fewer infections suggest that how rATG is administered may impact its efficacy and safety.
DOI: 10.1097/TP.0000000000000250
PubMed: 25083614
PubMed Central: PMC4281164
Links to Exploration step
pubmed:25083614Le document en format XML
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Foster</name></author><author><name sortKey="Miles, Clifford D" sort="Miles, Clifford D" uniqKey="Miles C" first="Clifford D" last="Miles">Clifford D. Miles</name></author><author><name sortKey="Lane, James T" sort="Lane, James T" uniqKey="Lane J" first="James T" last="Lane">James T. Lane</name></author><author><name sortKey="Kalil, Andre C" sort="Kalil, Andre C" uniqKey="Kalil A" first="Andre C" last="Kalil">Andre C. Kalil</name></author><author><name sortKey="Florescu, Diana F" sort="Florescu, Diana F" uniqKey="Florescu D" first="Diana F" last="Florescu">Diana F. Florescu</name></author><author><name sortKey="Sandoz, John P" sort="Sandoz, John P" uniqKey="Sandoz J" first="John P" last="Sandoz">John P. Sandoz</name></author><author><name sortKey="Rigley, Theodore H" sort="Rigley, Theodore H" uniqKey="Rigley T" first="Theodore H" last="Rigley">Theodore H. 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Foster</name></author><author><name sortKey="Miles, Clifford D" sort="Miles, Clifford D" uniqKey="Miles C" first="Clifford D" last="Miles">Clifford D. Miles</name></author><author><name sortKey="Lane, James T" sort="Lane, James T" uniqKey="Lane J" first="James T" last="Lane">James T. Lane</name></author><author><name sortKey="Kalil, Andre C" sort="Kalil, Andre C" uniqKey="Kalil A" first="Andre C" last="Kalil">Andre C. Kalil</name></author><author><name sortKey="Florescu, Diana F" sort="Florescu, Diana F" uniqKey="Florescu D" first="Diana F" last="Florescu">Diana F. Florescu</name></author><author><name sortKey="Sandoz, John P" sort="Sandoz, John P" uniqKey="Sandoz J" first="John P" last="Sandoz">John P. Sandoz</name></author><author><name sortKey="Rigley, Theodore H" sort="Rigley, Theodore H" uniqKey="Rigley T" first="Theodore H" last="Rigley">Theodore H. Rigley</name></author><author><name sortKey="Nielsen, Kathleen J" sort="Nielsen, Kathleen J" uniqKey="Nielsen K" first="Kathleen J" last="Nielsen">Kathleen J. Nielsen</name></author><author><name sortKey="Skorupa, Jill Y" sort="Skorupa, Jill Y" uniqKey="Skorupa J" first="Jill Y" last="Skorupa">Jill Y. Skorupa</name></author><author><name sortKey="Kellogg, Anna M" sort="Kellogg, Anna M" uniqKey="Kellogg A" first="Anna M" last="Kellogg">Anna M. Kellogg</name></author><author><name sortKey="Malik, Tamer" sort="Malik, Tamer" uniqKey="Malik T" first="Tamer" last="Malik">Tamer Malik</name></author><author><name sortKey="Wrenshall, Lucile E" sort="Wrenshall, Lucile E" uniqKey="Wrenshall L" first="Lucile E" last="Wrenshall">Lucile E. Wrenshall</name></author></analytic><series><title level="j">Transplantation</title><idno type="eISSN">1534-6080</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>Animals (MeSH)</term><term>Antilymphocyte Serum (administration & dosage)</term><term>Antilymphocyte Serum (adverse effects)</term><term>Drug Administration Schedule (MeSH)</term><term>Drug Therapy, Combination (MeSH)</term><term>Female (MeSH)</term><term>Graft Rejection (diagnosis)</term><term>Graft Rejection (immunology)</term><term>Graft Rejection (mortality)</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 (adverse effects)</term><term>Kaplan-Meier Estimate (MeSH)</term><term>Kidney Transplantation (adverse effects)</term><term>Kidney Transplantation (mortality)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Multivariate Analysis (MeSH)</term><term>Mycophenolic Acid (administration & dosage)</term><term>Mycophenolic Acid (analogs & derivatives)</term><term>Proportional Hazards Models (MeSH)</term><term>Rabbits (MeSH)</term><term>Risk Factors (MeSH)</term><term>Sirolimus (administration & dosage)</term><term>Steroids (administration & dosage)</term><term>Tacrolimus (administration & dosage)</term><term>Time Factors (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antilymphocyte Serum</term><term>Immunosuppressive Agents</term><term>Mycophenolic Acid</term><term>Sirolimus</term><term>Steroids</term><term>Tacrolimus</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antilymphocyte Serum</term><term>Immunosuppressive Agents</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Kidney Transplantation</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Mycophenolic Acid</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Graft Rejection</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Graft Survival</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Graft Rejection</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Graft Rejection</term><term>Kidney Transplantation</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Graft Rejection</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Animals</term><term>Drug Administration Schedule</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Multivariate Analysis</term><term>Proportional Hazards Models</term><term>Rabbits</term><term>Risk Factors</term><term>Time Factors</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>We conducted a randomized and unblinded 2 × 2 sequential-factorial trial, composed of an induction arm (part 1) comparing single-dose (SD) versus divided-dose rabbit antithymocyte globulin (rATG), and a maintenance arm (part 2) comparing tacrolimus minimization versus withdrawal. We report the long-term safety and efficacy of SD-rATG induction in the context of early steroid withdrawal and tacrolimus minimization or withdrawal.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Patients (n=180) received 6 mg/kg rATG, SD or four alternate-day doses (1.5 mg/kg/dose), with early steroid withdrawal and tacrolimus or sirolimus maintenance. After 6 months targeted maintenance levels were tacrolimus, 2 to 4 ng/mL and sirolimus, 4 to 6 ng/mL or, if calcineurin inhibitor-withdrawn, sirolimus 8 to 12 ng/mL with mycophenolate mofetil 2 g two times per day. Primary endpoints were renal function (abbreviated modification of diet in renal disease) and chronic graft histopathology (Banff). Secondary endpoints included patient survival, graft survival, biopsy-proven rejection, and infectious or noninfectious complications.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Follow-up averaged longer than 4 years. Tacrolimus or sirolimus and mycophenolate mofetil exposure was identical between groups. The SD-rATG associated with improved renal function (2-36 months; P<0.001) in deceased donor recipients. The SD-rATG associated with quicker lymphocyte, CD4 T cell, and CD4-CD8 recovery and fewer infections. Cox multivariate hazard modeling showed divided-dose-rATG (P=0.019), deceased donor (P=0.003), serious infection (P=0.0.018), and lower lymphocyte count (P=0.001) associated with increased mortality. Patients with all four covariates showed a 27-fold increased likelihood of death (P=0.00002). Chronic graft histopathology, rejection rates, and death-censored graft survival were not significantly different between groups.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>The SD-rATG induction improves the 3-year renal function in recipients of deceased donor kidneys. This benefit, along with possibly improved patient survival and fewer infections suggest that how rATG is administered may impact its efficacy and safety.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25083614</PMID><DateCompleted><Year>2015</Year><Month>02</Month><Day>19</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1534-6080</ISSN><JournalIssue CitedMedium="Internet"><Volume>99</Volume><Issue>1</Issue><PubDate><Year>2015</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Transplantation</Title><ISOAbbreviation>Transplantation</ISOAbbreviation></Journal><ArticleTitle>A randomized 2×2 factorial trial, part 1: single-dose rabbit antithymocyte globulin induction may improve renal transplantation outcomes.</ArticleTitle><Pagination><MedlinePgn>197-209</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1097/TP.0000000000000250</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">We conducted a randomized and unblinded 2 × 2 sequential-factorial trial, composed of an induction arm (part 1) comparing single-dose (SD) versus divided-dose rabbit antithymocyte globulin (rATG), and a maintenance arm (part 2) comparing tacrolimus minimization versus withdrawal. We report the long-term safety and efficacy of SD-rATG induction in the context of early steroid withdrawal and tacrolimus minimization or withdrawal.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Patients (n=180) received 6 mg/kg rATG, SD or four alternate-day doses (1.5 mg/kg/dose), with early steroid withdrawal and tacrolimus or sirolimus maintenance. After 6 months targeted maintenance levels were tacrolimus, 2 to 4 ng/mL and sirolimus, 4 to 6 ng/mL or, if calcineurin inhibitor-withdrawn, sirolimus 8 to 12 ng/mL with mycophenolate mofetil 2 g two times per day. Primary endpoints were renal function (abbreviated modification of diet in renal disease) and chronic graft histopathology (Banff). Secondary endpoints included patient survival, graft survival, biopsy-proven rejection, and infectious or noninfectious complications.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Follow-up averaged longer than 4 years. Tacrolimus or sirolimus and mycophenolate mofetil exposure was identical between groups. The SD-rATG associated with improved renal function (2-36 months; P<0.001) in deceased donor recipients. The SD-rATG associated with quicker lymphocyte, CD4 T cell, and CD4-CD8 recovery and fewer infections. Cox multivariate hazard modeling showed divided-dose-rATG (P=0.019), deceased donor (P=0.003), serious infection (P=0.0.018), and lower lymphocyte count (P=0.001) associated with increased mortality. Patients with all four covariates showed a 27-fold increased likelihood of death (P=0.00002). Chronic graft histopathology, rejection rates, and death-censored graft survival were not significantly different between groups.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">The SD-rATG induction improves the 3-year renal function in recipients of deceased donor kidneys. This benefit, along with possibly improved patient survival and fewer infections suggest that how rATG is administered may impact its efficacy and safety.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Stevens</LastName><ForeName>R Brian</ForeName><Initials>RB</Initials><AffiliationInfo><Affiliation>1 Department of Surgery, Wright State University Boonshoft School of Medicine, Dayton, OH. 2 Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, NE. 3 Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE. 4 Department of Internal Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK. 5 Sigma Analytics, Inc., Anthem, AZ. 6 Department of Surgery, Methodist Hospital, Houston, TX.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Foster</LastName><ForeName>Kirk W</ForeName><Initials>KW</Initials></Author><Author ValidYN="Y"><LastName>Miles</LastName><ForeName>Clifford D</ForeName><Initials>CD</Initials></Author><Author ValidYN="Y"><LastName>Lane</LastName><ForeName>James T</ForeName><Initials>JT</Initials></Author><Author ValidYN="Y"><LastName>Kalil</LastName><ForeName>Andre C</ForeName><Initials>AC</Initials></Author><Author ValidYN="Y"><LastName>Florescu</LastName><ForeName>Diana F</ForeName><Initials>DF</Initials></Author><Author ValidYN="Y"><LastName>Sandoz</LastName><ForeName>John P</ForeName><Initials>JP</Initials></Author><Author ValidYN="Y"><LastName>Rigley</LastName><ForeName>Theodore H</ForeName><Initials>TH</Initials></Author><Author ValidYN="Y"><LastName>Nielsen</LastName><ForeName>Kathleen J</ForeName><Initials>KJ</Initials></Author><Author ValidYN="Y"><LastName>Skorupa</LastName><ForeName>Jill Y</ForeName><Initials>JY</Initials></Author><Author ValidYN="Y"><LastName>Kellogg</LastName><ForeName>Anna M</ForeName><Initials>AM</Initials></Author><Author ValidYN="Y"><LastName>Malik</LastName><ForeName>Tamer</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Wrenshall</LastName><ForeName>Lucile E</ForeName><Initials>LE</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00556933</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D003160">Comparative Study</PublicationType><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></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Transplantation</MedlineTA><NlmUniqueID>0132144</NlmUniqueID><ISSNLinking>0041-1337</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000961">Antilymphocyte Serum</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007166">Immunosuppressive Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013256">Steroids</NameOfSubstance></Chemical><Chemical><RegistryNumber>HU9DX48N0T</RegistryNumber><NameOfSubstance UI="D009173">Mycophenolic Acid</NameOfSubstance></Chemical><Chemical><RegistryNumber>W36ZG6FT64</RegistryNumber><NameOfSubstance UI="D020123">Sirolimus</NameOfSubstance></Chemical><Chemical><RegistryNumber>WM0HAQ4WNM</RegistryNumber><NameOfSubstance UI="D016559">Tacrolimus</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000818" MajorTopicYN="N">Animals</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000961" MajorTopicYN="N">Antilymphocyte Serum</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006084" MajorTopicYN="N">Graft Rejection</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006085" MajorTopicYN="N">Graft Survival</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">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="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016030" MajorTopicYN="N">Kidney Transplantation</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015999" MajorTopicYN="N">Multivariate Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009173" MajorTopicYN="N">Mycophenolic Acid</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000031" MajorTopicYN="N">analogs & derivatives</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011817" MajorTopicYN="N">Rabbits</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020123" MajorTopicYN="N">Sirolimus</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013256" MajorTopicYN="N">Steroids</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016559" MajorTopicYN="N">Tacrolimus</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>8</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate 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