Journal
CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY
Volume 15, Issue 1, Pages 109-116Publisher
AMER SOC NEPHROLOGY
DOI: 10.2215/CJN.04840419
Keywords
delayed graft function; ischemia-reperfusion; kidney transplantation; humans; complement C1 inhibitor protein; complement c1s; double-blind method; glomerular filtration rate; incidence; tissue donors; death; human EGFR protein; epidermal growth factor receptor; reperfusion injury
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Funding
- CSL Behring
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Background and objectives Delayed graft function is related to ischemia-reperfusion injury and may be complement dependent. We previously reported from a randomized, placebo-controlled trial that treatment with C1 esterase inhibitor was associated with a shorter duration of delayed graft function and higher eGFR at 1 year. Here, we report longer-term outcomes from this trial. Design, setting, participants, & measurements This is a post hoc analysis of a phase 1/2, randomized, controlled trial enrolling 70 recipients of deceased donor kidney transplants at risk for delayed graft function(NCT02134314). Subjects were randomized to receive C1 esterase inhibitor 50 U/kg (n=35) or placebo (n=35) intraoperatively and at 24 hours. The cumulative incidence functions method was used to compare graft failure and death over 3.5 years. eGFR slopes were compared using a linear mixed effects model. Results Three deaths occurred among C1 esterase inhibitor-treated patients compared with none receiving placebo. Seven graft failures developed in the placebo group compared with one among C1 esterase inhibitor-treated recipients; the cumulative incidence of graft failure was lower over 3.5 years among C1 esterase inhibitor-treated recipients compared with placebo (P=0.03). Although no difference in eGFR slopes was observed between groups ( P for group-time interaction =0.12), eGFR declined in placebo-treated recipients (-4ml/min per 1.73m(2) per year; 95% confidence interval, -8 to -0.1) but was stable in C1 esterase inhibitor-treated patients (eGFR slope: 0.5ml/min per 1.73m(2) per year; 95% confidence interval, 24 to 5). At 3.5 years, eGFR was 56 ml/min per 1.73m(2) (95% confidence interval, 42 to 70) in the C1 esterase inhibitor group versus 35 ml/min per 1.73m2 (95% confidence interval, 21 to 48) in the placebo group, with an estimated mean eGFR difference of 21 ml/min per 1.73 m(2) (95% confidence interval, 2 to 41 ml/min per 1.73 m(2)). Conclusions Treatment of patients at risk for ischemia-reperfusion injury and delayed graft function with C1 esterase inhibitor was associated with a lower incidence of graft failure.
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