| Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation. | |
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MedLine Citation:
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PMID: 22471345 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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There is increasing interest in tacrolimus-minimization regimens. ASSET was an open-label, randomized, 12-month study of everolimus plus tacrolimus in de-novo renal-transplant recipients. Everolimus trough targets were 3-8 ng/ml throughout the study. Tacrolimus trough targets were 4-7 ng/ml during the first 3 months and 1.5-3 ng/ml (n = 107) or 4-7 ng/ml (n = 117) from Month 4. All patients received basiliximab induction and corticosteroids. The primary objective was to demonstrate superior estimated glomerular filtration rate (eGFR; MDRD-4) at Month 12 in the tacrolimus 1.5-3 ng/ml versus the 4-7 ng/ml group. Secondary endpoints included incidence of biopsy-proven acute rejection (BPAR; Months 4-12) and serious adverse events (SAEs; Months 0-12). Statistical significance was not achieved for the primary endpoint (mean eGFR: 57.1 vs. 51.7 ml/min/1.73 m(2) ), potentially due to overlapping of achieved tacrolimus exposure levels (Month 12 mean ± SD, tacrolimus 1.5-3 ng/ml: 3.4 ± 1.4; tacrolimus 4-7 ng/ml: 5.5 ± 2.0 ng/ml). BPAR (months 4-12) and SAE rates were comparable between groups (2.7% vs. 1.1% and 58.7% vs. 51.3%; respectively). Everolimus-facilitated tacrolimus minimization, to levels lower than previously investigated, achieved good renal function, low BPAR and graft-loss rates, and an acceptable safety profile in renal transplantation over 12 months although statistically superior renal function of the 1.5-3 ng/ml tacrolimus group was not achieved. (ClinicalTrials.gov: NCT00369161) is registered at http://www.clinicaltrials.gov. |
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Authors:
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Robert M Langer; Ronald Hené; Stefan Vitko; Maarten Christiaans; Helio Tedesco-Silva; Kazimierz Ciechanowski; Elisabeth Cassuto; Lionel Rostaing; Mario Vilatoba; Uwe Machein; Bettina Ulbricht; Guido Junge; Gaohong Dong; Julio Pascual |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-3-26 |
Journal Detail:
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Title: Transplant international : official journal of the European Society for Organ Transplantation Volume: 25 ISSN: 1432-2277 ISO Abbreviation: - Publication Date: 2012 May |
Date Detail:
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Created Date: 2012-4-4 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8908516 Medline TA: Transpl Int Country: - |
Other Details:
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Languages: ENG Pagination: 592-602 Citation Subset: - |
Copyright Information:
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© 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation. |
Affiliation:
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Department of Transplantation and Surgery, Semmelweis University, Budapest, Hungary Department of Nephrology, University Medical Centre, Utrecht, The Netherlands Institute of Clinical and Experimental Medicine, Transplant Centre, Prague, Czech Republic Division of Nephrology, Department of Internal Medicine, Academisch Ziekenhuis Maastricht, Maastricht, The Netherlands Division of Nephrology, Hospital do Rim e Hipertensâo, São Paulo, Brazil Department of Nephrology, Transplantology and Internal Medicine, Szczecin, Poland Service de Néphrologie, Hôpital Pasteur, CHU Nice, France Department of Nephrology-Dialysis-Organ Transplantation, Hôpital Rangueil, Toulouse, France Departamento de Trasplantes, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico Novartis Pharma AG, Basel, Switzerland Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA Servicio de Nefrología, Hospital del Mar, Barcelona, Spain. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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