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Everolimus renal transplantation

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https://www.readbyqxmd.com/read/28316834/the-cecari-study-everolimus-certican%C3%A2-initiation-and-calcineurin-inhibitor-withdrawal-in-maintenance-heart-transplant-recipients-with-renal-insufficiency-a-multicenter-randomized-trial
#1
Jan Van Keer, David Derthoo, Olivier Van Caenegem, Michel De Pauw, Eric Nellessen, Nathalie Duerinckx, Walter Droogne, Gábor Vörös, Bart Meyns, Ann Belmans, Stefan Janssens, Johan Van Cleemput, Johan Vanhaecke
In this 3-year, open-label, multicenter study, 57 maintenance heart transplant recipients (>1 year after transplant) with renal insufficiency (eGFR 30-60 mL/min/1.73 m(2)) were randomized to start everolimus with CNI withdrawal (N = 29) or continue their current CNI-based immunosuppression (N = 28). The primary endpoint, change in measured glomerular filtration rate (mGFR) from baseline to year 3, did not differ significantly between both groups (+7.0 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p = 0...
2017: Journal of Transplantation
https://www.readbyqxmd.com/read/28258601/incidence-and-outcome-of-bk-polyomavirus-infection-in-a-multicenter-randomized-controlled-trial-with-renal-transplant-patients-receiving-cyclosporine-mycophenolate-sodium-or-everolimus-based-low-dose-immunosuppressive-therapy
#2
Willem B van Doesum, Lilli Gard, Frederike J Bemelman, Johan W de Fijter, Jaap J Homan van der Heide, Hubert G M Niesters, Willem J van Son, Coen A Stegeman, Henk Groen, Annelies Riezebos-Brilman, Jan Stephan F Sanders
INTRODUCTION: It remains unclear whether overall degree of immunosuppression or specific effects of individual immunosuppressive agents are causal for increased occurrence of BK polyomavirus (BKPyV) infection in renal transplant recipients (RTR). METHODS: A prospective, multicenter, open-label randomized controlled trial in 361 de novo RTR was performed. A total of 224 RTR were randomized at 6 months into three treatment groups with dual therapy consisting of prednisolone (Pred) plus either cyclosporine (CsA), mycophenolate sodium (MPS), or everolimus (EVL)...
March 4, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28230646/effect-of-calcineurin-inhibitor-free-everolimus-based-immunosuppressive-regimen-on-albuminuria-and-glomerular-filtration-rate-after-heart-transplantation
#3
Lærke M Nelson, Arne K Andreassen, Bert Andersson, Einar Gude, Hans Eiskjær, Göran Rådegran, Göran Dellgren, Lars Gullestad, Finn Gustafsson
BACKGROUND: Albuminuria in maintenance heart transplantation (HTx) is associated with poor renal response when switching to a calcineurin inhibitor (CNI)-lowered or free immunosuppressive regimen using everolimus (EVR), but the significance of albuminuria associated with EVR treatment after early CNI withdrawal in de novo HTx is unknown. METHODS: We tested if glomerular filtration rate (mGFR, measured by CrEDTA clearance) was associated with urine albumin/creatinine ratio (UACR) post-HTx in a subgroup of patients included in the SCHEDULE trial, where de novo HTx patients (n=115) were randomized to EVR with complete CNI elimination 7-11 weeks post-HTx or standard CNI immunosuppression...
February 23, 2017: Transplantation
https://www.readbyqxmd.com/read/28230639/mammalian-target-of-rapamycin-inhibition-clinical-transplantation-liver
#4
Björn Nashan
The evidence base concerning use of mammalian target of rapamycin (mTOR) inhibitor therapy after liver transplantation is evolving rapidly, clarifying their benefits and disadvantages in different clinical scenarios. The H2304 trial showed that starting everolimus at 1 month posttransplant, with reduced tacrolimus, achieves a sustained improvement in renal function versus standard tacrolimus-based therapy, with at least equivalent immunosuppressive efficacy. Randomized studies evaluating early discontinuation of CNI therapy after introduction of an mTOR inhibitor consistently demonstrated a substantial improvement in renal function versus standard CNI therapy...
February 23, 2017: Transplantation
https://www.readbyqxmd.com/read/28141897/association-of-clinical-events-with-everolimus-exposure-in-kidney-transplant-patients-receiving-low-doses-of-tacrolimus
#5
F Shihab, Y Qazi, S Mulgaonkar, K McCague, D Patel, V R Peddi, D Shaffer
A key objective in the use of immunosuppression following kidney transplantation is to attain the optimal balance between efficacy and safety. In a Phase IIIb, multi-center, randomized, open-label, non-inferiority study, incidence of clinical events, renal dysfunction and adverse events (AEs) were analyzed at 12 months in 309 de novo renal transplant recipients receiving everolimus (EVR), low-dose Tac (LTac) and prednisone. Cox proportional hazard regression modeling was used to estimate the probability of clinical events at specified combinations of time-normalized EVR and Tac trough concentrations...
January 31, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28133906/efficacy-and-safety-of-everolimus-and-mycophenolic-acid-with-early-tacrolimus-withdrawal-after-liver-transplantation-a-multicenter-randomized-trial
#6
Faouzi Saliba, Christophe Duvoux, Jean Gugenheim, Nassim Kamar, Sébastien Dharancy, Ephrem Salamé, Martine Neau-Cransac, François Durand, Pauline Houssel-Debry, Claire Vanlemmens, Georges Pageaux, Jean Hardwigsen, Daniel Eyraud, Yvon Calmus, Fabienne Di Giambattista, Jérôme Dumortier, Filomena Conti
SIMCER was a six-month, multicenter, open-label trial. Selected de novo liver transplant recipients were randomized (week 4) to everolimus with low-exposure tacrolimus discontinued by month 4 (n=93), or tacrolimus-based therapy (n=95), both with basiliximab induction and enteric-coated mycophenolate sodium ± steroids. The primary endpoint, change in estimated GFR (eGFR, MDRD) from randomization to week 24 post-transplant, was superior with everolimus: mean eGFR change +1.1mL/min/1.73m(2)  for everolimus versus -13...
January 30, 2017: American Journal of Transplantation
https://www.readbyqxmd.com/read/28121741/effect-of-early-everolimus-facilitated-reduction-of-tacrolimus-on-efficacy-and-renal-function-in-de-novo-liver-transplant-recipients-24-month-results-for-the-north-american-subpopulation
#7
William C Chapman, Robert S Brown, Kenneth D Chavin, Debra Sudan, Baburao Koneru, Guido Junge, Gaohong Dong, Dharmesh Patel, Lewis Teperman, John J Fung
BACKGROUND: A recent randomized phase III study of 719 de novo liver transplant recipients showed that early everolimus plus reduced-dose tacrolimus (EVR + rTAC) led to significantly better kidney function than standard TAC (TAC-C), without compromising efficacy. In that study, patients from North America (n = 211) had increased risk factors for posttransplant renal insufficiency at study start, relative to patients from Europe and rest of world (eg, worse renal function, more diabetes, older age)...
February 2017: Transplantation
https://www.readbyqxmd.com/read/28119255/limitations-of-current-liver-transplant-immunosuppressive-regimens-renal-considerations
#8
Wei Zhang, John Fung
BACKGROUND: The use of calcineurin inhibitor (CNI)-based immunosuppressive regimens following liver transplantation (LTx) has improved the outcomes of the recipients. However, CNI has nephrotoxicity and causes short- and long-term renal complications. The progressive structural changes can be irreversible in the long-term, leading to chronic kidney dysfunction. The present review was to evaluate the different strategies of CNI application to renal function in liver recipients. DATA SOURCES: PubMed database was searched for relevant articles in English on the issue of immunosuppressive regimen and kidney injury that related to early minimization of CNI after LTx...
February 2017: Hepatobiliary & Pancreatic Diseases International: HBPD INT
https://www.readbyqxmd.com/read/28107397/efficacy-and-safety-of-everolimus-for-maintenance-immunosuppression-of-kidney-transplantation-a-meta-analysis-of-randomized-controlled-trials
#9
Jinyu Liu, Dong Liu, Juan Li, Lan Zhu, Chengliang Zhang, Kai Lei, Qiling Xu, Ruxu You
BACKGROUND: Conversion to everolimus is often used in kidney transplantation to overcome calcineurin inhibitor (CNI) nephrotoxicity but there is conflicting evidence for this approach. OBJECTIVES: To investigate the benefits and harm from randomized clinical trials (RCTs) involving the conversion from CNI to everolimus after kidney transplantation. METHODS: Databases were searched up to March 2016. Two reviewers independently assessed trials for eligibility and quality, and extracted data...
2017: PloS One
https://www.readbyqxmd.com/read/28104152/experience-of-quatro-therapy-with-everolimus-to-minimize-calcineurin-inhibitor-for-kidney-transplant-recipients
#10
N Nakamura, T Miyazaki, H Matsuzaki, R Furuya, S Miyajima, S Irie, H Matsuoka, M Tanaka
BACKGROUND: This study was divided into three phases, on the occasion of the introduction of everolimus (EVR) in our hospital. METHODS: In the first phase, a study group of six maintenance patients (three living related donors, three deceased donors) who had a history of malignant disease with less than 500 mg/day of proteinuria were enrolled; a high serum creatinine and upper limit of duration after kidney transplant operation was not considered. EVR was discontinued in four of the six patients because of side effects or worsening renal function...
January 2017: Transplantation Proceedings
https://www.readbyqxmd.com/read/28058211/organ-transplantation-and-drug-eluting-stents-perioperative-challenges
#11
REVIEW
Aparna Dalal
Patients listed for organ transplant frequently have severe coronary artery disease (CAD), which may be treated with drug eluting stents (DES). Everolimus and zotarolimus eluting stents are commonly used. Newer generation biolimus and novolimus eluting biodegradable stents are becoming increasingly popular. Patients undergoing transplant surgery soon after the placement of DES are at increased risk of stent thrombosis (ST) in the perioperative period. Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor such as clopidogrel, prasugrel and ticagrelor is instated post stenting to decrease the incident of ST...
December 24, 2016: World Journal of Transplantation
https://www.readbyqxmd.com/read/28027625/early-conversion-from-calcineurin-inhibitor-to-everolimus-based-therapy-following-kidney-transplantation-results-of-the-randomized-elevate-trial
#12
Johan W de Fijter, Hallvard Holdaas, Ole Øyen, Jan-Stephan Sanders, Sankaran Sundar, Frederike J Bemelman, Claudia Sommerer, Julio Pascual, Yingyos Avihingsanon, Cholatip Pongskul, Frederic Oppenheimer, Lorenzo Toselli, Graeme Russ, Zailong Wang, Patricia Lopez, Jossy Kochuparampil, Josep M Cruzado, Markus van der Giet
In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n=359) or remain on standard calcineurin inhibitor (CNI) therapy (n=356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated GFR from randomization to month 12, was similar for everolimus versus CNI: mean (SE) 0.3(1.5)mL/min/1.73(2) versus -1.5(1.5)mL/min/1.73(2) (p=0.116). At month 24, mean (SD) estimated GFR was 62...
December 27, 2016: American Journal of Transplantation
https://www.readbyqxmd.com/read/27988326/everolimus-tdm-using-thermo-fisher-qms-immunoassay-on-indiko-beckman-dxc-au680-and-au5800-analyzers
#13
Steven Hy Wong, Kamisha L Johnson-Davis, Krista Garrison, Joe D Rankin, Chro S Muhammad
OBJECTIVES: Everolimus (EVR), a mTOR inhibitor immunosuppressant approved for renal, liver and cardiac transplants. This study established the appropriate TDM performances of the Thermo Scientific QMS EVR Assay by using the Beckman DxC, followed by comparison to the Thermo Scientific Indiko and a previously published LC-MS/MS assay, and Beckman AU680 and AU5800 analyzers. DESIGN AND METHODS: The study initially established acceptable linearity, precision and accuracy of the QMS EVR turbidimetric assay...
December 15, 2016: Clinical Biochemistry
https://www.readbyqxmd.com/read/27915965/systematic-review-on-role-of-mammalian-target-of-rapamycin-inhibitors-as-an-alternative-to-calcineurin-inhibitors-in-renal-transplant-challenges-and-window-to-excel
#14
Jayant Kumar, Julie M Bridson, Ajay Sharma, Ahmed Halawa
OBJECTIVES: This review focuses on the current limited evidence of graft function and graft survival in various immunosuppressive regimens involving mammalian target of rapamycin inhibitors with or without calcineurin inhibitors. MATERIALS AND METHODS: We evaluated the current literature for describing the role of mammalian target of rapamycin inhibitors as an alternative to calcineurin inhibitors by searching the PubMed, EMBASE, Cochrane, Crossref, and Scopus databases using medical subject heading terms...
December 2, 2016: Experimental and Clinical Transplantation
https://www.readbyqxmd.com/read/27862340/everolimus-with-early-withdrawal-or-reduced-dose-calcineurin-inhibitors-improves-renal-function-in-liver-transplant-recipients-a-systematic-review-and-meta-analysis
#15
Michael Lin, Sahil Mittal, Farhad Sahebjam, Abbas Rana, Gagan K Sood
Calcineurin inhibitors (CNI) are the mainstay of immunosuppression after liver transplantation (LT), but CNIs are associated with significant nephrotoxicity. Recently, mTOR inhibitors such as sirolimus and everolimus (EVR) have been used with or without CNIs in LT recipients for their renal-sparing effect. We conducted a systematic review and meta-analysis of randomized controlled trials (RCT) that examined the effect of EVR with CNI minimization or withdrawal on renal function in LT recipients. RCT of primary adult LT recipients with baseline GFR >30 mL/min who received EVR with CNI minimization or withdrawal were included...
November 16, 2016: Clinical Transplantation
https://www.readbyqxmd.com/read/27798513/longitudinal-pharmacokinetics-of-everolimus-when-combined-with-low-level-of-tacrolimus-in-elderly-renal-transplant-recipients
#16
Elias David-Neto, Fabiana Agena, Fernanda Ramos, Ana Heloisa Triboni, Paschoalina Romano, Persio de Almeida Rezende Ebner, Venceslau Coelho, Nelson Zocoler Galante, Francine Carvalinho Lemos
BACKGROUND: Although the proportion of elderly patients among renal transplant recipients has increased, pharmacokinetic (PK) studies of immunosuppressants rarely include older patients. METHODS: We studied 12-hours everolimus (EVL) PK in 16 elderly renal transplant recipients (all caucasians; 10 males; mean age, 64±2 years, (61-71y), in 4 separate time-points (at 7, 30, 60 and 150 days) after EVL introduction, corresponding to a mean post renal-transplantation day: PK1 (43±4days), PK2 (65±7 days), PK3 (106±17 days) and PK4 (206±40 days)...
October 28, 2016: Transplantation
https://www.readbyqxmd.com/read/27797804/everolimus-associated-stomatitis-in-a-patient-who-had-renal-transplant
#17
Yisi D Ji, Ali Aboalela, Alessandro Villa
Everolimus is used as an immunosuppressant in renal allograft transplant rejection and in metastatic breast cancer treatment. One side effect of everolimus is stomatitis, referred to as mammalian target of rapamycin inhibitor-associated stomatitis. This side effect can affect treatment course and contribute to discontinuation of therapy or dose reduction, previously reported in the treatment of metastatic breast cancer. Here, we present a case of everolimus-associated stomatitis with a novel management method with intralesional triamcinolone that allows for continuous course of everolimus...
October 19, 2016: BMJ Case Reports
https://www.readbyqxmd.com/read/27793122/acute-pancreatitis-associated-with-everolimus-after-kidney-transplantation-a-case-report
#18
Francesco Fontana, Gianni Cappelli
BACKGROUND: Acute pancreatitis (AP) following KT is a rare and often fatal complication of the early post-transplant period. Common causative factors for AP are rare after KT; anti-rejection drugs as CyA, prednisone and MMF have been implicated, although evidence is not strong and we found no reports on possible causative role for mTOR inhibitors. CASE PRESENTATION: A 55-year-old Caucasian man with end-stage renal disease due to idiopathic membrano-prolipherative glomerulonephritis underwent single kidney transplantation (KT) from cadaveric donor...
October 28, 2016: BMC Nephrology
https://www.readbyqxmd.com/read/27775865/efficacy-and-safety-of-everolimus-plus-low-dose-tacrolimus-versus-mycophenolate-mofetil-plus-standard-dose-tacrolimus-in-de-novo-renal-transplant-recipients-12-month-data
#19
Y Qazi, D Shaffer, B Kaplan, D Y Kim, F L Luan, V R Peddi, F Shihab, S Tomlanovich, S Yilmaz, K McCague, D Patel, S Mulgaonkar
In this 12-month, multicenter, randomized, open-label, noninferiority study, de novo renal transplant recipients (RTxRs) were randomized (1:1) to receive everolimus plus low-dose tacrolimus (EVR+LTac) or mycophenolate mofetil plus standard-dose Tac (MMF+STac) with induction therapy (basiliximab or rabbit anti-thymocyte globulin). Noninferiority of composite efficacy failure rate (treated biopsy-proven acute rejection [tBPAR]/graft loss/death/loss to follow-up) in EVR+LTac versus MMF+STac was missed by 1.4%, considering the noninferiority margin of 10% (24...
October 24, 2016: American Journal of Transplantation
https://www.readbyqxmd.com/read/27742336/safety-and-efficacy-of-early-everolimus-when-calcineurin-inhibitors-are-not-recommended-in-orthotopic-liver-transplantation
#20
M Gastaca, I Bilbao, M Jimenez, J Bustamante, C Dopazo, R Gonzalez, R Charco, J Santoyo, J Ortiz de Urbina
Our aim was to study the safety and efficacy of immunosuppression with everolimus (EVL) within the 1st month after orthotopic liver transplantation (LT) when calcineurin inhibitors are not recommended. For this purpose, 28 recipients who had been treated with EVL within the 1st month after adult LT were eligible to enter in a retrospective multicenter study. Patients were followed up for 12 months after LT. EVL therapy was initiated at a median of 14 days (range, 4-24) after LT. The reason for early EVL was neurotoxicity in 14 cases, renal dysfunction in 12, and acute cellular rejection combined with renal impairment in 2...
September 2016: Transplantation Proceedings
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