Université de Paris Cité, INSERM, PARCC, Paris Translational Research Centre for Organ Transplantation, F-75015 Paris, France.
Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb, Zagreb, Croatia.
BMJ. 2023 May 31;381:e073654. doi: 10.1136/bmj-2022-073654.
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.
Development and validation study SETTING: 17 cohorts in Europe, the United States, and Australia (14 transplant centres, three clinical trials).
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.
The main outcome measure was GFR, measured according to local practice. Performance of the GFR equations was assessed using P (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.
The study included 15 489 participants, with 50 464 mGFR and eGFR values. The mean GFR was 53.18 mL/min/1.73m (SD 17.23) in the development cohort and 55.90 mL/min/1.73m (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 (P 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 (P 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/).
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.
ClinicalTrials.gov NCT05229939.
比较新开发的无种族肾脏受者专用肾小球滤过率(GFR)方程与当前用于测量肾移植受者 GFR 的三种主要方程的性能。
开发和验证研究
欧洲、美国和澳大利亚的 17 个队列(14 个移植中心,3 个临床试验)。
15489 名成年人(开发队列中有 3622 名(法国 Necker、Saint Louis 和 Toulouse 医院),11867 名在多个外部验证队列中),他们在 2000 年 1 月 1 日至 2021 年 1 月 1 日之间接受了肾脏移植。
主要观察指标为 GFR,根据当地实践进行测量。通过 P(估计肾小球滤过率(eGFR)与测量肾小球滤过率(mGFR)的 30%内的比例)和正确分类(根据 GFR 阶段的 eGFR 与 mGFR 的一致性)评估 GFR 方程的性能。基于肌酐水平、年龄和性别开发的无种族方程,使用加性和乘法线性回归,将其性能与三种当前主要 GFR 方程进行比较:改良肾脏病饮食研究(MDRD)方程、慢性肾脏病流行病学合作(CKD-EPI)2009 方程和无种族 CKD-EPI 2021 方程。
本研究纳入了 15489 名参与者,共获得 50464 个 mGFR 和 eGFR 值。开发队列中的平均 GFR 为 53.18mL/min/1.73m(SD 17.23),外部验证队列中的平均 GFR 为 55.90mL/min/1.73m(19.69)。在当前的 GFR 方程中,与 MDRD 和 CKD-EPI 2009 方程相比,无种族 CKD-EPI 2021 方程显示出最低的性能。当种族被纳入肾脏受者特异性 GFR 方程时,性能并没有提高。无种族肾脏受者特异性 GFR 方程与无种族 CKD-EPI 2021 方程相比,性能显著提高,在外部验证队列中表现良好(P 范围为 73.0%至 91.3%)。无种族肾脏受者特异性 GFR 方程在按种族(73.0%至 91.3%)、性别(72.7%至 91.4%)、年龄(70.3%至 92.0%)、身体质量指数(64.5%至 100%)、供体类型(58.5%至 92.9%)、供体年龄(68.3%至 94.3%)、治疗(78.5%至 85.2%)、肌酐水平(72.8%至 91.3%)、GFR 测量方法(73.0%至 91.3%)和移植后 GFR 测量时间(72.9%至 95.5%)进行分层的几个肾移植受者亚组中表现良好。开发了一个在线应用程序,可根据受者的肌酐水平、年龄和性别估算 GFR(https://transplant-prediction-system.shinyapps.io/eGFR_equation_KTX/)。
使用多个大型国际肾移植受者队列开发和验证了一种新的无种族肾脏受者专用 GFR 方程。该方程具有较高的准确性,并优于为具有原生肾脏的个体开发的无种族 CKD-EPI 2021 方程。
ClinicalTrials.gov NCT05229939。