Phenotype of Urinary CD4+ T Cells as Biomarkers for Prediction of Outcome in Lupus Nephritis
试验速览
- 阶段
- 不适用
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis
研究概览
简要总结
Urinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. In a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). Treatment will be performed to the discretion of the treating clinician. After 6 months of treatment response will be determined as either complete response or partial response.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven lupus nephritis
- •In absence of a biopsy a SLEDAI of at least 10 & at least two renal elements of the renal SLEDAI (rSLEDAI)
- •Informed consent
- •Diagnosis of SLE according to the American College of Rheumatology (ACR) criteria
排除标准
- •Biopsy-proven non-SLE related disease
- •Urinary tract infection
- •Active menstrual bleeding
- •Kidney transplantation during observation time
结局指标
主要结局
Phenotype of CD4+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis
时间窗: 6 months
Urinary CD4+ effector/memory T cell counts at time point 0 (time of diagnosis) predict clinical outcome (complete or partial response) after 6 months of treatment in patients with lupus nephritis. The frequency of effector/memory CD4+ T lymphocytes is higher in patients with non- or partial response. * Complete response at 24 weeks: the return to within 10 percent of normal values of serum creatinine levels, proteinuria, and urine sediment. * Partial response at 24 weeks: improvement of 50 percent in all abnormal renal measurements, without worsening - within 10 percent - of any measurement
次要结局
- Distinction between proliferative LN (class III and class IV) and non-proliferative LN (classes I, II and VI)(6 months)
- Analysis of patient with persistent renal abnormalities as partial response(6 months)
- Diagnosis of proliferative lupus nephritis in patients with systemic lupus erythematodes (SLE)(6 months)
- Prediction of complete or partial response according to normalization of the amount of urinary T cells at time point 2 and 4(6 months)
- Phenotype of CD8+ T cells at time point 0 predictive of clinical outcome in patients with lupus nephritis(6 months)
研究者
Philipp Enghard
PD Dr. med.
Charite University, Berlin, Germany