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Early everolimus introduction and tacrolimus minimization after liver transplantation may represent a novel immunosuppressant approach. This phase 2, multicenter, randomized, open-label trial evaluated safety and efficacy of early everolimus initiation. Patients treated with corticosteroids, tacrolimus, and basiliximab, were randomized (2:1) to receive everolimus (1.5 mg bid) in day 8 and gradually minimize or withdraw tacrolimus when everolimus was stable >5 ng/mL, or to continue tacrolimus at 6-12 ng/mL. Primary endpoint was the proportion of treated biopsy proven acute rejection (tBPAR)-free patients at 3 months after transplant. As secondary endpoints, composite tBPAR plus graft/patient loss rate, renal function, tacrolimus discontinuation rate, and adverse events were assessed. Ninety-three patients were treated with everolimus and 47 were controls. After 3 months from transplantation, 87.1% of patients with everolimus and 95.7% of controls were tBPAR-free (p=0.09); composite endpoint-free patients with everolimus were 85% (vs 94%, p=0.15). 37.6% patients were in monotherapy with everolimus at 3 months; tBPAR rate was 11.4%. eGFR was significantly higher with everolimus, as early as 2 weeks after randomization. In the study group higher rate of dyslipidemia (15% vs 6.3%), wound complication (18.2% vs 0) and incisional hernia (25.8% vs 6.3%) were observed while neurological disorders were more frequent in control group (13.9% vs 31.9%) p<0.05. In conclusion, an early everolimus introduction and tacrolimus minimization may represent a suitable approach, when immediate preservation of renal function is crucial. NCT01423708 This article is protected by copyright. All rights reserved.
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We have read with great interest the article by Kubal et al. (1) that reported the impact of human leukocyte antigen (HLA) epitope mismatch (MM) on de novo donor specific HLA alloantibodies (DSA) for...
De novo malignancies are one of the major late complications and cause of death after liver transplantation (LT). Using extensive data from the French national Agence de la Biomédecine database, the ...
Early studies reported poor survival rates following liver transplantation for metastatic colorectal cancer to the liver and liver transplantation has thus traditionally been contraindicated for these...
Nonalcoholic Steatohepatitis(NASH) is one of the top three indications for liver transplantation in western countries. It is unknown whether renal dysfunction at the time of liver transplantation has ...
T-cell mediated rejection (TCMR) is common after liver transplantation (LT), and is often thought to have minimum impact on outcomes. Because alloimmune response changes over time, we investigated the...
The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and...
This trial is designed to address important issues that impact recipients of liver allografts as well as clinicians, ie. renal function, reduction or discontinuation of tacrolimus early po...
The purpose of this study is to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complicati...
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with...
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in ...
A form of ischemia-reperfusion injury occurring in the early period following transplantation. Significant pathophysiological changes in MITOCHONDRIA are the main cause of the dysfunction. It is most often seen in the transplanted lung, liver, or kidney and can lead to GRAFT REJECTION.
Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed.
The transference of a part of or an entire liver from one human or animal to another.
Genes that show rapid and transient expression in the absence of de novo protein synthesis. The term was originally used exclusively for viral genes where immediate-early referred to transcription immediately following virus integration into the host cell. It is also used to describe cellular genes which are expressed immediately after resting cells are stimulated by extracellular signals such as growth factors and neurotransmitters.
Conditions in which the LIVER functions fall below the normal ranges. Severe hepatic insufficiency may cause LIVER FAILURE or DEATH. Treatment may include LIVER TRANSPLANTATION.
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...