Objective To compare the performance of a newly developed race-free kidney recipient specific glomerular filtration rate (GFR) equation with the three current main equations for measuring GFR in kidney transplant recipients. Design Development and validation study Setting 17 cohorts in Europe, the United States, and Australia (14 transplant centres, three clinical trials). Participants 15 489 adults (3622 in development cohort (Necker, Saint Louis, and Toulouse hospitals, France), 11 867 in multiple external validation cohorts) who received kidney transplants between 1 January 2000 and 1 January 2021. Main outcome measure The main outcome measure was GFR, measured according to local practice. Performance of the GFR equations was assessed using P30 (proportion of estimated GFR (eGFR) within 30% of measured GFR (mGFR)) and correct classification (agreement between eGFR and mGFR according to GFR stages). The race-free equation, based on creatinine level, age, and sex, was developed using additive and multiplicative linear regressions, and its performance was compared with the three current main GFR equations: Modification of Diet in Renal Disease (MDRD) equation, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2009 equation, and race-free CKD-EPI 2021 equation. Results The study included 15 489 participants, with 50 464 mGFR and eGFR values. The mean GFR was 53.18 mL/min/1.73m2 (SD 17.23) in the development cohort and 55.90 mL/min/1.73m2 (19.69) in the external validation cohorts. Among the current GFR equations, the race-free CKD-EPI 2021 equation showed the lowest performance compared with the MDRD and CKD-EPI 2009 equations. When race was included in the kidney recipient specific GFR equation, performance did not increase. The race-free kidney recipient specific GFR equation showed significantly improved performance compared with the race-free CKD-EPI 2021 equation and performed well in the external validation cohorts (P30 ranging from 73.0% to 91.3%). The race-free kidney recipient specific GFR equation performed well in several subpopulations of kidney transplant recipients stratified by race (P30 73.0-91.3%), sex (72.7-91.4%), age (70.3-92.0%), body mass index (64.5-100%), donor type (58.5-92.9%), donor age (68.3-94.3%), treatment (78.5-85.2%), creatinine level (72.8-91.3%), GFR measurement method (73.0-91.3%), and timing of GFR measurement post-transplant (72.9-95.5%). An online application was developed that estimates GFR based on recipient’s creatinine level, age, and sex ([https://transplant-prediction-system.shinyapps.io/eGFR\_equation\_KTX/][1]). Conclusion A new race-free kidney recipient specific GFR equation was developed and validated using multiple, large, international cohorts of kidney transplant recipients. The equation showed high accuracy and outperformed the race-free CKD-EPI 2021 equation that was developed in individuals with native kidneys. Trial registration ClinicalTrials.gov [NCT05229939][2]. Data are available from the corresponding author at alexandreloupy@gmail.com upon reasonable request for research purpose only. Deidentified participant level data from the development cohort will be made available upon reasonable request. Requests will be assessed by the members of the Paris Transplant Group. For validation cohorts, data access is not covered by our data transfer agreements. [1]: https://transplant-prediction-system.shinyapps.io/eGFR_equation_KTX/ [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05229939&atom=%2Fbmj%2F381%2Fbmj-2022-073654.atom

中文翻译：

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肾移植受者的无种族估计肾小球滤过率方程：开发和验证研究

目的 将新开发的无种族肾移植受者特异性肾小球滤过率 (GFR) 方程与当前用于测量肾移植受者 GFR 的三个主要方程的性能进行比较。设计开发和验证研究 在欧洲、美国和澳大利亚设置 17 个队列（14 个移植中心，三个临床试验）。参与者 2000 年 1 月 1 日至 2021 年 1 月 1 日期间接受肾移植的 15 489 名成年人（发展队列中 3622 名（法国内克尔、圣路易斯和图卢兹医院），多个外部验证队列中 11 867 名）。 主要结果指标 主要结果指标是 GFR，根据当地实践测量。使用 P30（估计 GFR (eGFR) 在测量 GFR (mGFR) 30% 范围内的比例）和正确分类（根据 GFR 阶段 eGFR 和 mGFR 之间的一致性）评估 GFR 方程的性能。使用加法和乘法线性回归建立了基于肌酐水平、年龄和性别的无种族方程，并将其性能与当前三个主要 GFR 方程进行了比较：肾病饮食修改 (MDRD) 方程、慢性肾脏疾病流行病学协作 (CKD-EPI) 2009 方程和无种族 CKD-EPI 2021 方程。结果 该研究包括 15 489 名参与者，mGFR 和 eGFR 值为 50 464。开发队列中的平均 GFR 为 53.18 mL/min/1.73m2 (SD 17.23)，外部验证队列中的平均 GFR 为 55.90 mL/min/1.73m2 (19.69)。在当前的 GFR 方程中，与 MDRD 和 CKD-EPI 2009 方程相比，无竞争的 CKD-EPI 2021 方程表现出最低的性能。当种族被纳入肾脏受体特定 GFR 方程时，表现并没有提高。与无种族的 CKD-EPI 2021 方程相比，无种族的肾受体特异性 GFR 方程显示出显着改善的性能，并且在外部验证队列中表现良好（P30 范围为 73.0% 至 91.3%）。无种族肾移植受者特异性 GFR 方程在按种族 (P30 73.0-91.3%)、性别 (72.7-91.4%)、年龄 (70.3-92.0%)、体重指数 (64.5) 分层的肾移植受者的几个亚群中表现良好。 -100%)、供者类型(58.5-92.9%)、供者年龄(68.3-94.3%)、治疗(78.5-85.2%)、肌酐水平(72.8-91.3%)、GFR测量方法(73.0-91.3%)、移植后 GFR 测量的时间（72.9-95.5%）。我们开发了一个在线应用程序，可以根据接受者的肌酐水平、年龄和性别来估计 GFR ([https://transplant-prediction-system.shinyapps.io/eGFR\_equation\_KTX/][1])。结论 开发了一种新的不分种族的肾移植受者特异性 GFR 方程，并使用多个大型国际肾移植受者队列进行了验证。该方程显示出很高的准确性，并且优于在具有天然肾脏的个体中开发的无种族 CKD-EPI 2021 方程。试验注册 ClinicalTrials.gov [NCT05229939][2]。数据可从通讯作者 alexandreloupy@gmail.com 处获取，仅出于研究目的提出合理请求。来自开发队列的未识别的参与者级别数据将根据合理要求提供。请求将由巴黎移植小组的成员进行评估。对于验证队列，我们​​的数据传输协议不涵盖数据访问。[1]: https://transplant-prediction-system.shinyapps.io/eGFR_equation_KTX/ [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05229939&atom=%2Fbmj%2F381%2Fbmj-2022-073654.atom