肝细胞生长因子模拟物 ANG-3777 在移植功能延迟的肾移植受者中的应用:随机 3 期试验的结果。

IF 8.9 2区 医学 Q1 SURGERY American Journal of Transplantation Pub Date : 2024-09-01 DOI:10.1016/j.ajt.2024.02.014
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引用次数: 0

摘要

在肾移植受者中,移植功能延迟(DGF)会增加移植失败和死亡的风险。在一项 3 期随机、双盲、安慰剂对照试验中,我们研究了肝细胞生长因子模拟物 ANG-3777(每天一次,连续 3 天,从移植后≤30 小时开始)在 248 名接受首次肾移植的已故供体患者中的应用情况。第 360 天时,ANG-3777 组和安慰剂组的估计肾小球滤过率(eGFR;主要终点)无显著差异。在第 30 天之前的透析持续时间或第 360 天时 eGFR >30 mL/min/1.73m2 的患者比例方面,组间差异不明显。ANG-3777组和安慰剂组的DGF和急性排斥反应发生率相似(分别为68.5% vs 69.4%和8.1% vs 6.5%)。ANG-3777的耐受性良好,移植失败的发生率比安慰剂低(3.2% vs 8.1%)。虽然目前还没有足够的证据支持将 ANG-3777 用于死体供肾移植后有肾功能障碍风险的患者,但这些研究结果表明它具有潜在的生物活性,值得进一步研究。Clinicaltrials.gov 编号:NCT02474667:NCT02474667。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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The hepatocyte growth factor mimetic, ANG-3777, in kidney transplant recipients with delayed graft function: Results from a randomized phase 3 trial

In kidney transplant recipients, delayed graft function increases the risk of graft failure and mortality. In a phase 3, randomized, double-blind, placebo-controlled trial, we investigated the hepatocyte growth factor mimetic, ANG-3777 (once daily for 3 consecutive days, starting ≤30 hours posttransplant), in 248 patients receiving a first kidney transplant from a deceased donor. At day 360, estimated glomerular filtration rate (primary endpoint) was not significantly different between the ANG-3777 and placebo groups. There were no significant between-group differences in the duration of dialysis through day 30 or in the percentage of patients with an estimated glomerular filtration rate of >30 mL/min/1.73 m2 at day 360. The incidence of both delayed graft function and acute rejection was similar between ANG-3777 and placebo groups (68.5% vs 69.4% and 8.1% vs 6.5%, respectively). ANG-3777 was well tolerated, and there was a numerically lower incidence of graft failure versus placebo (3.2% vs 8.1%). Although there is insufficient evidence to support an indication of ANG-3777 for patients at risk of renal dysfunction after deceased-donor kidney transplantation, these findings indicate potential biological activity that may warrant further investigation.

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来源期刊
CiteScore
18.70
自引率
4.50%
发文量
346
审稿时长
26 days
期刊介绍: The American Journal of Transplantation is a leading journal in the field of transplantation. It serves as a forum for debate and reassessment, an agent of change, and a major platform for promoting understanding, improving results, and advancing science. Published monthly, it provides an essential resource for researchers and clinicians worldwide. The journal publishes original articles, case reports, invited reviews, letters to the editor, critical reviews, news features, consensus documents, and guidelines over 12 issues a year. It covers all major subject areas in transplantation, including thoracic (heart, lung), abdominal (kidney, liver, pancreas, islets), tissue and stem cell transplantation, organ and tissue donation and preservation, tissue injury, repair, inflammation, and aging, histocompatibility, drugs and pharmacology, graft survival, and prevention of graft dysfunction and failure. It also explores ethical and social issues in the field.
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