BACKGROUND AND OBJECTIVES:Delayed graft function (DGF) is associated with adverse long-term outcomes after deceased-donor kidney (DDK) transplantation. Ischemia-reperfusion injury plays a crucial role in the development of DGF. On the basis of promising animal data, this study evaluated any potential benefits of erythropoietin-alfa (EPO-α) given intra-arterially at the time of reperfusion of renal allograft on the degree of allograft function, as well as tubular cell injury measured by urinary biomarkers in the early post-transplant period. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the influence of EPO-α administered intraoperatively on the outcomes of DDK transplantations performed at the study center between March 2007 and July 2009. RESULTS:Seventy-two patients were randomly assigned to EPO-α (n=36) or placebo (n=36). The incidences of DGF, slow graft function, and immediate graft function did not significantly differ between the treatment and control groups (41.7% versus 47.2%, 25.0% versus 36.1%, and 33.3% versus 16.7%, respectively; P=0.24). The groups had similar levels of urinary biomarkers, including neutrophil gelatinase-associated lipocalin and IL-18 at multiple times points soon after transplantation; urinary output during the first 3 postoperative days; 1-month renal function; and BP readings, hemoglobin, and adverse effects during the first month. CONCLUSIONS: This study did not show any clinically demonstrable beneficial effects of high-dose EPO-α given intra-arterially during the early reperfusion phase in DDK transplant recipients in terms of reducing the incidence of DGF or improving short-term allograft function.
RCT Entities:
BACKGROUND AND OBJECTIVES: Delayed graft function (DGF) is associated with adverse long-term outcomes after deceased-donor kidney (DDK) transplantation. Ischemia-reperfusion injury plays a crucial role in the development of DGF. On the basis of promising animal data, this study evaluated any potential benefits of erythropoietin-alfa (EPO-α) given intra-arterially at the time of reperfusion of renal allograft on the degree of allograft function, as well as tubular cell injury measured by urinary biomarkers in the early post-transplant period. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the influence of EPO-α administered intraoperatively on the outcomes of DDK transplantations performed at the study center between March 2007 and July 2009. RESULTS: Seventy-two patients were randomly assigned to EPO-α (n=36) or placebo (n=36). The incidences of DGF, slow graft function, and immediate graft function did not significantly differ between the treatment and control groups (41.7% versus 47.2%, 25.0% versus 36.1%, and 33.3% versus 16.7%, respectively; P=0.24). The groups had similar levels of urinary biomarkers, including neutrophil gelatinase-associated lipocalin and IL-18 at multiple times points soon after transplantation; urinary output during the first 3 postoperative days; 1-month renal function; and BP readings, hemoglobin, and adverse effects during the first month. CONCLUSIONS: This study did not show any clinically demonstrable beneficial effects of high-dose EPO-α given intra-arterially during the early reperfusion phase in DDK transplant recipients in terms of reducing the incidence of DGF or improving short-term allograft function.
Authors: Carsten Hafer; Thomas Becker; Jan T Kielstein; Elisabeth Bahlmann; Anke Schwarz; Nikolai Grinzoff; Daria Drzymala; Isabelle Bonnard; Nicolas Richter; Frank Lehner; Juergen Klempnauer; Hermann Haller; Jana Traeder; Danilo Fliser Journal: Kidney Int Date: 2011-10-19 Impact factor: 10.612
Authors: A L Sirén; M Fratelli; M Brines; C Goemans; S Casagrande; P Lewczuk; S Keenan; C Gleiter; C Pasquali; A Capobianco; T Mennini; R Heumann; A Cerami; H Ehrenreich; P Ghezzi Journal: Proc Natl Acad Sci U S A Date: 2001-03-20 Impact factor: 11.205
Authors: Azrina Md Ralib; John W Pickering; Geoffrey M Shaw; Prasad Devarajan; Charles L Edelstein; Joseph V Bonventre; Zoltan H Endre Journal: J Am Soc Nephrol Date: 2011-11-17 Impact factor: 10.121
Authors: Isaac E Hall; Sri G Yarlagadda; Steven G Coca; Zhu Wang; Mona Doshi; Prasad Devarajan; Won K Han; Richard J Marcus; Chirag R Parikh Journal: J Am Soc Nephrol Date: 2009-09-17 Impact factor: 10.121
Authors: Zoltán H Endre; Robert J Walker; John W Pickering; Geoffrey M Shaw; Christopher M Frampton; Seton J Henderson; Robyn Hutchison; Jan E Mehrtens; Jillian M Robinson; John B W Schollum; Justin Westhuyzen; Leo A Celi; Robert J McGinley; Isaac J Campbell; Peter M George Journal: Kidney Int Date: 2010-02-17 Impact factor: 10.612
Authors: Chirag R Parikh; Alkesh Jani; Vyacheslav Y Melnikov; Sarah Faubel; Charles L Edelstein Journal: Am J Kidney Dis Date: 2004-03 Impact factor: 8.860
Authors: Longhui Qiu; Xingqiang Lai; Jiao-Jing Wang; Xin Yi Yeap; Shulin Han; Feibo Zheng; Charlie Lin; Zhuoli Zhang; Daniele Procissi; Deyu Fang; Lin Li; Edward B Thorp; Michael M Abecassis; Yashpal S Kanwar; Zheng J Zhang Journal: Kidney Int Date: 2020-08-18 Impact factor: 10.612
Authors: Mark de Caestecker; Ben D Humphreys; Kathleen D Liu; William H Fissell; Jorge Cerda; Thomas D Nolin; David Askenazi; Girish Mour; Frank E Harrell; Nick Pullen; Mark D Okusa; Sarah Faubel Journal: J Am Soc Nephrol Date: 2015-11-04 Impact factor: 10.121
Authors: Willem G van Rijt; Gertrude J Nieuwenhuijs-Moeke; Harry van Goor; Bente Jespersen; Petra J Ottens; Rutger J Ploeg; Henri G D Leuvenink Journal: J Transl Med Date: 2013-01-09 Impact factor: 5.531