Department of Population Health, NYU Grossman School of Medicine, New York City, New York, USA
Department of Population Health, NYU Grossman School of Medicine, New York City, New York, USA.
Lupus Sci Med. 2024 Nov 21;11(2):e001390. doi: 10.1136/lupus-2024-001390.
Lupus nephritis (LN) is a frequent complication of SLE, occurring in up to 60% of adult patients and ultimately progressing from acute inflammation to chronicity with fibrosis and end-stage kidney failure in 10%-30% of patients. Racial/ethnic minority patients with lupus have worse long-term outcomes, including progression to end-stage renal disease and overall mortality. A major challenge in the management of patients with SLE is delayed identification of early kidney disease, which ultimately leads to a greater burden on both patients and the health system.
Using a mixed methods approach, this study will develop, adapt and evaluate a home urine sampling protocol with a text-messaging reminder and data capture system for patients at elevated risk of de novo LN or relapse. First, a feasibility pilot using a single-group trial design (n=18) will be implemented, with a feasibility assessment and qualitative, debriefing interviews with patients to further refine the intervention. The second phase is a comparative effectiveness trial of the intervention (n=160) with the primary outcome of biopsy eligibility, that is, the participant has a clinical indication for a kidney biopsy (urine protein-creatinine ratio≥0.5), whether or not the patient actually undergoes the biopsy procedure. The randomised trial includes an economic evaluation of the adapted home urinalysis protocol.
It is unknown whether weekly home-based urine sampling can identify proteinuria sooner than standard care; if found sooner, kidney problems could be diagnosed earlier, hopefully leading to earlier care for less-involved disease and subsequent reduced morbidity. The data collected in this trial will inform future feasibility and effectiveness of text-messaging-based home urine sampling interventions.
The randomised trial will be registered with ClincialTrials.gov prior to enrolment start.
狼疮肾炎（LN）是系统性红斑狼疮（SLE）的常见并发症，在成年患者中发生率高达 60%，最终在 10%-30%的患者中从急性炎症发展为慢性纤维化和终末期肾衰竭。患有狼疮的少数族裔患者的长期预后更差，包括进展为终末期肾病和总体死亡率。SLE 患者管理中的一个主要挑战是延迟识别早期肾脏疾病，这最终会给患者和医疗系统带来更大的负担。
本研究将采用混合方法，为处于新发 LN 或复发风险升高的患者开发、调整和评估一种家庭尿液采样方案，包括短信提醒和数据采集系统。首先，将实施一项基于单组试验设计的可行性试点研究（n=18），对干预措施进行可行性评估和定性、与患者进行深入访谈，以进一步完善干预措施。第二阶段是干预措施的比较有效性试验（n=160），主要结局是活检资格，即参与者有临床指征需要进行肾脏活检（尿蛋白-肌酐比≥0.5），无论患者是否实际进行了活检。随机试验包括对改良家庭尿液分析方案的经济评估。
目前尚不清楚每周家庭尿液采样是否能比标准护理更早地发现蛋白尿；如果更早发现，肾脏问题可能更早得到诊断，希望能更早开始治疗轻度疾病，并减少后续的发病率。该试验收集的数据将为基于短信的家庭尿液采样干预措施的未来可行性和有效性提供信息。
在开始入组前，将向 ClinicalTrials.gov 注册随机试验。
