1. Everolimus With Reduced Tacrolimus Improves Renal Function in De Novo Liver Transplant Recipients: A Randomized Controlled Trial
- Author
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De Simone, P, Nevens, Frederik, De Carlis, L, Metselaar, HJ, Beckebaum, S, Saliba, F, Jonas, S, Sudan, D, Fung, J, Fischer, L, Duvoux, C, Chavin, KD, Koneru, B, Huang, MA, Chapman, WC, Foltys, D, Witte, S, Jiang, H, Hexham, JM, Junge, G, for the H2304 Study Group, De Simone, P, Nevens, F, DE CARLIS, L, Metselaar, H, Beckebaum, S, Saliba, F, Jonas, S, Sudan, D, Fung, J, Fischer, L, Duvoux, C, Chavin, K, Koneru, B, Huang, M, Chapman, W, Foltys, D, Witte, S, Jiang, H, Hexham, J, Junge, G, and Gastroenterology & Hepatology
- Subjects
Graft Rejection ,CHRONIC KIDNEY-DISEASE ,Male ,Time Factors ,medicine.medical_treatment ,Medizin ,Kaplan-Meier Estimate ,Liver transplantation ,Kidney ,Kidney Function Tests ,GLOMERULAR-FILTRATION-RATE ,Immunosuppressive Agent ,HEPATOCELLULAR-CARCINOMA ,SIROLIMUS-BASED IMMUNOSUPPRESSION ,Immunology and Allergy ,Sirolimu ,Pharmacology (medical) ,Prospective Studies ,tacrolimus ,MYCOPHENOLATE-MOFETIL ,COMPLICATIONS ,Cross-Over Studies ,liver transplantation ,withdrawal ,Graft Survival ,Cross-Over Studie ,Middle Aged ,Treatment Outcome ,surgical procedures, operative ,Survival Analysi ,reduced ,Life Sciences & Biomedicine ,Immunosuppressive Agents ,Human ,Glomerular Filtration Rate ,medicine.drug ,Adult ,medicine.medical_specialty ,Randomization ,Time Factor ,Adolescent ,Efficacy ,Urology ,Renal function ,chemical and pharmacologic phenomena ,CALCINEURIN INHIBITOR ,Risk Assessment ,Drug Administration Schedule ,Follow-Up Studie ,Young Adult ,stomatognathic system ,Transplantation Immunology ,DOSE TACROLIMUS ,Confidence Intervals ,medicine ,Humans ,METAANALYSIS ,Aged ,Sirolimus ,Transplantation ,Kidney Function Test ,Science & Technology ,Everolimus ,Dose-Response Relationship, Drug ,business.industry ,everolimu ,tacrolimu ,Original Articles ,everolimus ,Survival Analysis ,Crossover study ,Tacrolimus ,Surgery ,Prospective Studie ,CONVERSION ,stomatognathic diseases ,business ,Confidence Interval ,Liver Failure ,Follow-Up Studies - Abstract
In a prospective, multicenter, open-label study, de novo liver transplant patients were randomized at day 30±5 to (i) everolimus initiation with tacrolimus elimination (TAC Elimination) (ii) everolimus initiation with reduced-exposure tacrolimus (EVR+Reduced TAC) or (iii) standard-exposure tacrolimus (TAC Control). Randomization to TAC Elimination was terminated prematurely due to a higher rate of treated biopsy-proven acute rejection (tBPAR). EVR+Reduced TAC was noninferior to TAC Control for the primary efficacy endpoint (tBPAR, graft loss or death at 12 months posttransplantation): 6.7% versus 9.7% (-3.0%; 95% CI -8.7, 2.6%; p
- Published
- 2012