Prediction of Lupus Renal Flares Study
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Renal flares within the next 6 months
研究概览
简要总结
In patients with systemic lupus erythematosus, urinary CD4+ T cells may have the potential to predict subsequent renal flares in the next 6 months. Patients with systemic lupus erythematosus from our outpatient clinic will be included in this cross-sectional, prospective biomarker study regardless of disease activity, clinical phenotype, and disease duration or baseline therapy. Urinary T cells will be analyzed by flow cytometry. 6 months after sample collection a clinical follow-up will be conducted to assess the occurrence of either recurrent or de novo renal flares.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria Stable immunosuppressive or biologic background therapy within the last 6 months prior to inclusion
排除标准
- •Age < 18
- •Inability to consent
- •Urinary tract infection (defined by detection of nitrite or positive urine culture)
- •Patients on chronic dialysis
- •Concomitant other autoimmune disease
结局指标
主要结局
Renal flares within the next 6 months
时间窗: 6 months
To evaluate whether the number of urinary CD4+ T cells has the potential to predict subsequent renal flares in the next 6 months. Renal flares will be defined as an increase of proteinuria by \> 0.5 g/g creatinine or an increase in creatinine by 30% without other likely explanation or a novel kidney biopsy demonstrating lupus nephritis.
次要结局
- To assess whether urinary or peripheral blood T- and B cell subsets or IFN-I activity can predict the incidence of mild/moderate or severe flares of SLE according to the SELENA-SLEDAI Flare Index (SFI)(6 months)
- To evaluate whether increased surface expression of CD38 on peripheral blood memory T cells is associated with the presence of renal involvement.(6 months)
- To investigate whether the phenotype of urinary T cell subsets can predict renal involvement or subsequent renal flares in preexisting LN (CD4+ and CD8+ T cells subsets).(6 months)
- To investigate whether the number and phenotype of urinary B- and plasma cell subsets can predict renal involvement or subsequent renal flares in preexisting LN(6 months)
- Investigate whether Belimumab treatment has a beneficial impact on biomarkers associated with renal flares and loss of renal function.(6 months)
研究者
Philipp Enghard
PD Dr. med
Charite University, Berlin, Germany