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https://scholarbank.nus.edu.sg/handle/10635/229389
DC Field | Value | |
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dc.title | Randomized Trial of Everolimus-Facilitated Calcineurin Inhibitor Minimization Over 24 Months in Renal Transplantation | |
dc.contributor.author | Cibrik, Diane | |
dc.contributor.author | Silva, Helio Tedesco | |
dc.contributor.author | Vathsala, Anantharaman | |
dc.contributor.author | Lackova, Eva | |
dc.contributor.author | Cornu-Artis, Catherine | |
dc.contributor.author | Walker, Rowan G | |
dc.contributor.author | Wang, Zailong | |
dc.contributor.author | Zibari, Gazi B | |
dc.contributor.author | Shihab, Fuad | |
dc.contributor.author | Kim, Yu S | |
dc.date.accessioned | 2022-07-29T01:35:57Z | |
dc.date.available | 2022-07-29T01:35:57Z | |
dc.date.issued | 2013-04-15 | |
dc.identifier.citation | Cibrik, Diane, Silva, Helio Tedesco, Vathsala, Anantharaman, Lackova, Eva, Cornu-Artis, Catherine, Walker, Rowan G, Wang, Zailong, Zibari, Gazi B, Shihab, Fuad, Kim, Yu S (2013-04-15). Randomized Trial of Everolimus-Facilitated Calcineurin Inhibitor Minimization Over 24 Months in Renal Transplantation. TRANSPLANTATION 95 (7) : 933-942. ScholarBank@NUS Repository. | |
dc.identifier.issn | 00411337 | |
dc.identifier.issn | 15346080 | |
dc.identifier.uri | https://scholarbank.nus.edu.sg/handle/10635/229389 | |
dc.description.abstract | BACKGROUND: Strategies allowing calcineurin inhibitor minimization while maintaining efficacy may improve renal transplant outcomes. METHODS: A2309 was a 24-month, phase IIIb, open-label trial of 833 de novo renal transplant recipients randomized to everolimus, targeting trough concentrations of 3-8 or 6-12 ng/mL plus reduced-exposure cyclosporine A (CsA) or to mycophenolic acid (MPA) 1.44 g per day plus standard-exposure CsA. All patients received basiliximab±corticosteroids. The incidence of the primary composite efficacy endpoint and its components (treated biopsy-proven acute rejection, graft loss, death, or loss to follow-up), renal function (serum creatinine and estimated glomerular filtration rate), and adverse events (AEs) were compared at 24 months; as per the protocol, these analyses were not noninferiority. RESULTS: Composite efficacy failure rates (95% confidence interval for difference vs. MPA) were 32.9% (-2.2%, 13.0%), 26.9% (-7.9%, 6.8%), and 27.4% at month 24 in the everolimus 3-8 and 6-12 ng/mL and MPA groups, respectively. Mean estimated glomerular filtration rate (Modification of Diet in Renal Disease) at month 24 was 52.2 (-2.1, 5.5 mL/min/1.73 m), 49.4 (-4.8, 2.7 mL/min/1.73 m), and 50.5 mL/min/1.73 m, respectively. AEs were generally mild to moderate in severity and comparable between the groups. AEs leading to discontinuation were reported in 28.5% (P=0.03 vs. MPA), 30.6% (P=0.007 vs. MPA), and 20.5% of patients receiving everolimus 3-8 and 6-12 ng/mL and MPA, respectively. CONCLUSIONS: Everolimus trough concentrations targeted to 3-8 ng/mL, along with a greater than 60% reduction in CsA exposure, was associated with comparable efficacy and renal function versus MPA plus standard-exposure CsA over the 2-year period. A significantly higher incidence of AEs led to discontinuation in the everolimus groups compared with the MPA group. Copyright © 2013 by Lippincott Williams & Wilkins. | |
dc.description.uri | http://libproxy1.nus.edu.sg/login?url=http://dx.doi.org/10.1097/TP.0b013e3182848e03 | |
dc.language.iso | en | |
dc.publisher | LIPPINCOTT WILLIAMS & WILKINS | |
dc.source | Elements | |
dc.subject | Science & Technology | |
dc.subject | Life Sciences & Biomedicine | |
dc.subject | Immunology | |
dc.subject | Surgery | |
dc.subject | Transplantation | |
dc.subject | Calcineurin inhibitor toxicity | |
dc.subject | Cyclosporine | |
dc.subject | Everolimus | |
dc.subject | Renal function | |
dc.subject | Renal transplantation | |
dc.subject | GLOMERULAR-FILTRATION-RATE | |
dc.subject | GRAFT-SURVIVAL | |
dc.subject | CLASSIFICATION | |
dc.subject | REJECTION | |
dc.subject | PREDICTOR | |
dc.subject | RISK | |
dc.subject | CYCLOSPORINE | |
dc.subject | SIROLIMUS | |
dc.subject | DISEASE | |
dc.type | Article | |
dc.date.updated | 2022-07-23T07:50:29Z | |
dc.contributor.department | DEPT OF MEDICINE | |
dc.description.sourcetitle | TRANSPLANTATION | |
dc.description.volume | 95 | |
dc.description.issue | 7 | |
dc.description.page | 933-942 | |
dc.description.coden | TRPLA | |
dc.identifier.isiut | 000316990300016 | |
dc.description.place | United States | |
dc.published.state | Published | |
Appears in Collections: | Staff Publications Elements |
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File | Description | Size | Format | Access Settings | Version | |
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Transplantation 2013_Randomized Trial of Everolimus-Facilitated CNI Mini.pdf | 782.98 kB | Adobe PDF | CLOSED | Published |
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