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Y Qazi, D Shaffer, B Kaplan, D 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, non-inferiority 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). Non-inferiority of composite efficacy failure rate (tBPAR/graft loss/death/loss to follow-up) in EVR+LTac versus MMF+STac, was missed by 1.4% considering the non-inferiority margin of 10% (24...
October 24, 2016: American Journal of Transplantation
I Laranjinha, P Matias, C Jorge, R Birne, A Weigert, T Adragão, M Bruges, R A Cabrera, J Cassis, S Ramos, A Nogueira, J Godinho, H Messias, D Machado
BACKGROUND: Kidney transplant (KT) recipients have a higher incidence of malignancy than the general population. Smooth muscle tumors (SMT), including leiomyosarcoma, are rare in kidney transplant recipients, and most cases are associated with Epstein-Barr virus (EBV) infection. CASE REPORT: A 57-year-old man received a deceased donor kidney transplant at the age of 53 years, with 5 human leukocyte antigen (HLA) mismatches. Before the transplantation, the patient was IgG positive for EBV viral capsid antigen (VCA), negative for IgM EBV VCA, and also negative for IgG EBV nuclear antigen (EBNA), suggesting a prior EBV infection...
September 2016: Transplantation Proceedings
M Pereira, J Guerra, M Neves, J Gonçalves, A Santana, C Nascimento, A G da Costa
INTRODUCTION: The optimal immunosuppressive induction therapy in kidney transplant recipients with low immunologic risk of acute rejection (AR) is still controversial. The use of basiliximab (BSX) has led to a significant decrease of AR with a low side effect profile. OBJECTIVE: This study sought to evaluate predictive risk factors for AR in low immunologic risk patients subjected to immunosuppressive induction therapy with BSX. METHODS: We reviewed all low immunologic risk patients (panel reactive antibody [PRA] level <50%, who had undergone a first deceased-donor transplant) subjected to immunosuppressive induction therapy with BSX, calcineurin inhibitor, mycophenolate mofetil, and prednisolone (n = 346)...
September 2016: Transplantation Proceedings
R N Makroo, Soma Agrawal, Mohit Chowdhry, Brinda Kakkar, Uday K Thakur
BACKGROUND: Liver transplantation is one of the solid organs most commonly being transplanted across the world. The indications, affordability and accessibility have grown manifold. To increase the donor pool, inclusion of ABO incompatible liver donors is being considered. To enhance the graft functioning and survival, immunoadsorption apheresis to reduce the ABO hemagglutination titres are on the rise. CASE REPORT: We report three cases ABO incompatible liver transplantation with immunoadsorption protocol...
September 28, 2016: Transfusion and Apheresis Science
Jong Man Kim, Choon Hyuck David Kwon, Jae-Won Joh, Gyu-Seong Choi, Jae Berm Park, Eun-Suk Kang, Sung Joo Kim, Suk-Koo Lee
PURPOSE: T lymphocytes are an essential component of allograft rejection and tolerance. The aims of the present study are to analyze the characteristics of T-cell subsets between ABO-incompatible living donor liver transplantation (ABO-I LDLT) and ABO-compatible LDLT (ABO-C LDLT). MATERIALS AND METHODS: Between April 2013 and June 2014, 61 patients underwent adult LDLT. ABO-I LDLT patients received rituximab and all patients received basiliximab as induction therapy and tacrolimus as maintenance therapy...
October 13, 2016: Journal of Investigative Surgery: the Official Journal of the Academy of Surgical Research
Hideki Ishida, Shiro Takahara, Noritoshi Amada, Shinji Tomikawa, Tatsuya Chikaraishi, Kota Takahashi, Kazuhiro Uchida, Takahiro Akiyama, Kazunari Tanabe, Hiroshi Toma
OBJECTIVES: Our objectives were to compare the clinical outcomes of mizoribine (12 mg/kg/d) and mycophenolate mofetil (2000 mg/d) in combination with tacrolimus, basiliximab, and corticosteroids. MATERIALS AND METHODS: We enrolled 83 recipients of living-donor renal transplant (performed between 2008 and 2013) in this study. This prospective multi-institutional randomized comparative study compared mizoribine (n = 41) and mycophenolate mofetil (n = 42) in combination with tacrolimus, basiliximab, and corticosteroids for living-donor renal transplant recipients...
October 2016: Experimental and Clinical Transplantation
Jong Man Kim, Kwang-Woong Lee, Gi-Won Song, Bo-Hyun Jung, Hae Won Lee, Nam-Joon Yi, ChoonHyuck David Kwon, Shin Hwang, Kyung-Suk Suh, Jae-Won Joh, Suk-Koo Lee, Sung-Gyu Lee
BACKGROUND/AIMS: The relationship between patient survival and biopsy-proven acute rejection (BPAR) in liver transplant recipients with hepatitis C remains unclear. The aims of this study were to compare the characteristics of patients with and without BPAR and to identify risk factors for BPAR. METHODS: We retrospectively reviewed the records of 169 HCV-RNA-positive patients who underwent LT at three centers. RESULTS: BPAR occurred in 39 (23...
September 2016: Clinical and Molecular Hepatology
Abbas Rana, Bhamidipati Murthy, Zachery Pallister, Michael Kueht, Ronald Cotton, N Thao N Galvan, Whiston Etheridge, Hau Liu, John Goss, Christine O'Mahony
Careful management of immunosuppression is paramount to prevent acute rejection in kidney transplantation. We studied a cohort of 139,875 kidney transplant recipients from the Organ Procurement and Transplantation Network (OPTN) database between 2002 and 2013. We confirmed the analysis with a cohort of 35,277 who received thymoglobulin induction with tacrolimus maintenance, and a third cohort of 12,161 recipients who received basiliximab induction with tacrolimus maintenance. We performed multivariate logistic regression analyses on data from all three cohorts and identified independent risk factors for treated acute rejection at 1 year...
September 29, 2016: Journal of Nephrology
F J Bemelman, J W de Fijter, J Kers, C Meyer, H Peters-Sengers, E F de Maar, K A M I van der Pant, A P J de Vries, J-S Sanders, A Zwinderman, M M Idu, S Berger, M E J Reinders, C Krikke, I M Bajema, M C van Dijk, I J M Ten Berge, J Ringers, J Lardy, D Roelen, D-J Moes, S Florquin, J J Homan van der Heide
In renal transplantation, use of calcineurin inhibitors (CNIs) is associated with nephrotoxicity and immunosuppression with malignancies and infections. This trial aimed to minimize CNI exposure and total immunosuppression while maintaining efficacy. We performed a randomized controlled, open-label multicenter trial with early cyclosporine A (CsA) elimination. Patients started with basiliximab, prednisolone (P), mycophenolate sodium (MPS), and CsA. At 6 months, immunosuppression was tapered to P/CsA, P/MPS, or P/everolimus (EVL)...
September 17, 2016: American Journal of Transplantation
J Radtke, N Dietze, L Fischer, E-G Achilles, J Li, S Scheidat, F Thaiss, B Nashan, M Koch
BACKGROUND: BK polyomavirus (BKV) infection and BKV nephropathy (BKVN) are risk factors for allograft function and survival. METHODS: We retrospectively analyzed BK viremia and BKVN in 348 patients who received a kidney transplantation donated after brain death (n = 232) or living donation (n = 116) between 2008 and 2013. 266 patients were treated with standard immunosuppression consisting of basiliximab induction, calcineurin inhibitor (CNI), and mycophenolate (MPA, n = 219) or everolimus (n = 47)...
September 17, 2016: Transplant Infectious Disease: An Official Journal of the Transplantation Society
Tracey Jones-Hughes, Tristan Snowsill, Marcela Haasova, Helen Coelho, Louise Crathorne, Chris Cooper, Ruben Mujica-Mota, Jaime Peters, Jo Varley-Campbell, Nicola Huxley, Jason Moore, Matt Allwood, Jenny Lowe, Chris Hyde, Martin Hoyle, Mary Bond, Rob Anderson
BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring renal replacement therapy: kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation, followed by immunosuppressive therapy (induction and maintenance therapy) to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect(®), Novartis Pharmaceuticals UK Ltd) and rabbit anti-human thymocyte immunoglobulin (rATG) (Thymoglobulin(®), Sanofi) as induction therapy, and immediate-release tacrolimus (TAC) (Adoport(®), Sandoz; Capexion(®), Mylan; Modigraf(®), Astellas Pharma; Perixis(®), Accord Healthcare; Prograf(®), Astellas Pharma; Tacni(®), Teva; Vivadex(®), Dexcel Pharma), prolonged-release tacrolimus (Advagraf(®) Astellas Pharma), belatacept (BEL) (Nulojix(®), Bristol-Myers Squibb), mycophenolate mofetil (MMF) (Arzip(®), Zentiva; CellCept(®), Roche Products; Myfenax(®), Teva), mycophenolate sodium (MPS) (Myfortic(®), Novartis Pharmaceuticals UK Ltd), sirolimus (SRL) (Rapamune(®), Pfizer) and everolimus (EVL) (Certican(®), Novartis) as maintenance therapy in adult renal transplantation...
August 2016: Health Technology Assessment: HTA
Sarita Rani Jaiswal, Shamsuz Zaman, Aditi Chakrabarti, Amit Sehrawat, Satish Bansal, Mahesh Gupta, Suparno Chakrabarti
The outcome of hyperacute grade 3-4 steroid-refractory graft-versus-host-disease (SR-GVHD) remains dismal despite a plethora of agents being tried alone or in combination. Following T replete haploidentical transplantation with post-transplantation cyclophosphamide on 75 patients, 10 patients (13%) aged 2-20years, developed hyperacute SR-GVHD. We report on the outcome of two different regimens for treatment of SR-GVHD on the outcome of these patients. Five patients were treated in Regimen A consisting of anti-thymocyte globulin, Etanercept and Basiliximab...
August 27, 2016: Transplant Immunology
G Ciancio, P Tryphonopoulos, J J Gaynor, G Guerra, J Sageshima, D Roth, L Chen, W Kupin, A Mattiazzi, L Tueros, S Flores, L Hanson, R H Powell, P Ruiz, R Vianna, G W Burke
BACKGROUND: Recent studies suggest that the combination of tacrolimus (TAC) and everolimus (EVL) could become a viable option for use as standard maintenance immunosuppression in non-highly sensitized kidney transplant recipients. METHODS: We conducted a single-center, open-label, randomized pilot trial comparing two maintenance immunosuppression regimens in non-highly sensitized, adult, primary kidney transplant recipients: (TAC/EVL, Group A) vs our standard maintenance regimen of TAC plus enteric-coated mycophenolate mofetil (TAC/EC-MPS, Group B)...
July 2016: Transplantation Proceedings
Marcela Haasova, Tristan Snowsill, Tracey Jones-Hughes, Louise Crathorne, Chris Cooper, Jo Varley-Campbell, Ruben Mujica-Mota, Helen Coelho, Nicola Huxley, Jenny Lowe, Jan Dudley, Stephen Marks, Chris Hyde, Mary Bond, Rob Anderson
BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney function requiring kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation followed by induction and maintenance immunosuppressive therapy to reduce the risk of kidney rejection and prolong graft survival. OBJECTIVES: To systematically review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect,(®) Novartis Pharmaceuticals) and rabbit antihuman thymocyte immunoglobulin (Thymoglobuline,(®) Sanofi) as induction therapy and immediate-release tacrolimus [Adoport(®) (Sandoz); Capexion(®) (Mylan); Modigraf(®) (Astellas Pharma); Perixis(®) (Accord Healthcare); Prograf(®) (Astellas Pharma); Tacni(®) (Teva); Vivadex(®) (Dexcel Pharma)], prolonged-release tacrolimus (Advagraf,(®) Astellas Pharma); belatacept (BEL) (Nulojix,(®) Bristol-Myers Squibb), mycophenolate mofetil (MMF) [Arzip(®) (Zentiva), CellCept(®) (Roche Products), Myfenax(®) (Teva), generic MMF is manufactured by Accord Healthcare, Actavis, Arrow Pharmaceuticals, Dr Reddy's Laboratories, Mylan, Sandoz and Wockhardt], mycophenolate sodium, sirolimus (Rapamune,(®) Pfizer) and everolimus (Certican,(®) Novartis Pharmaceuticals) as maintenance therapy in children and adolescents undergoing renal transplantation...
August 2016: Health Technology Assessment: HTA
Kota Takahashi, Kazuhide Saito, Shiro Takahara, Shohei Fuchinoue, Takashi Yagisawa, Atsushi Aikawa, Yoshihiko Watarai, Norio Yoshimura, Kazunari Tanabe, Kunio Morozumi, Motohide Shimazu
BACKGROUND: Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy...
August 17, 2016: Clinical and Experimental Nephrology
Luciano Moscarelli, Giulia Antognoli, Elisa Buti, Egrina Dervishi, Filippo Fani, Leonardo Caroti, Aris Tsalouchos, Elena Romoli, Giulia Ghiandai, Enrico Minetti
Observation that 1,25-Dihydroxyvitamin-D3 has an immunomodulatory effect on innate and adaptive immunity raises the possible effect on clinical graft outcome. Aim of this study was to evaluate the correlation of biopsy-proven acute rejection, CMV infection, BKV infection, with 1,25-Dihydroxyvitamin-D3 deficiency and the benefit of calcitriol supplementation before and during the transplantation. Risk factors and kidney graft function were also evaluated. All RTRs received induction therapy with basiliximab, cyclosporine, mycophenolic acid, and steroids...
October 2016: Clinical Transplantation
Takahisa Hiramitsu, Manabu Okada, Kenta Futamura, Takayuki Yamamoto, Makoto Tsujita, Norihiko Goto, Shunji Narumi, Yoshihiko Watarai, Asami Takeda, Kenta Iwasaki, Kazuharu Uchida, Takaaki Kobayashi
The aim of this study is to evaluate the efficacy and safety of everolimus plus reduced-dose cyclosporine compared with mycophenolate mofetil plus standard-dose cyclosporine 5years after living donor kidney transplantation. Between March 2008 and August 2009, 24 living donor kidney transplantations were enrolled in a 2-year, multicenter, randomized phase 3 study (RAD001A1202 study). 24 recipients were randomly classified into two groups and closely observed for 5years. 13 recipients were administered steroid, reduced-dose cyclosporine, everolimus and basiliximab (EVR group)...
October 2016: International Immunopharmacology
Don Hayes, Patrick I McConnell, Andrew R Yates, Joseph D Tobias, Mark Galantowicz, Heidi M Mansour, Dmitry Tumin
BACKGROUND: Research on induction immunosuppression in patients undergoing combined heart-lung transplantation (HLTx) is limited. METHODS: The United Network for Organ Sharing database was queried from 2000 to 2013 to examine the influence of induction immunosuppression for combined HLTx in adult (≥18 years) and adolescent (≥12 and <18 years) recipients. RESULTS: Of 394 eligible combined HLTx cases (361 adults, 33 adolescents), 384 were included in univariate Cox analysis and 116 in the multivariate Cox model...
October 2016: Clinical Transplantation
Priscilla Ueno, Claudia Felipe, Alexandra Ferreira, Marina Cristelli, Laila Viana, Juliana Mansur, Geovana Basso, Pedro Hannun, Wilson Aguiar, Helio Tedesco-Silva, Jose Medina-Pestana
BACKGROUND: De novo use of mammalian target of rapamycin inhibitors after kidney transplantation is associated with a concentration-dependent incidence of wound healing adverse events (WHAE). The objective of this analysis was to compare the incidence of WHAE in patients receiving everolimus (EVR) or mycophenolate sodium (MPS). METHODS: This was a predefined sub-analysis of a single center prospective randomized study in which 288 kidney transplant recipients receiving tacrolimus (TAC) and prednisone were randomized for 3 different regimens: antithymocyte globulin (r-ATG)/EVR (N=85); basiliximab (BAS)/EVR (N=102); BAS/MPS (N=101)...
August 3, 2016: Transplantation
Kjersti Lønning, Karsten Midtvedt, Torbjørn Leivestad, Anna V Reisæter, Pål-Dag Line, Anders Hartmann, Kristian Heldal
BACKGROUND: Elderly patients are the fastest growing group in need of renal transplantation. This study puts focus on renal transplant recipients in their eightieth year or older at time of engraftment. Is there evidence to support an absolute upper age limit for renal transplantation? METHODS: Recipients in their eightieth year or older, transplanted between 1983 and 2015, were included. Data were retrieved from the Norwegian Renal Registry in the end of October 2015...
July 28, 2016: Transplantation
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