Adverse Renal Effects of Immune Checkpoints Inhibitors (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) in Clinical Practice: a Large Monocentric Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- Incidence of Acute kidney Injury
研究概览
简要总结
Renal toxic events related to Immune Checkpoints Inhibitors therapy (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) have been recently reported. These were immune-allergic acute interstitial nephritis.
However, no systematic study has ever focused on renal adverse effects. The investigators study here the evolution of renal function and the occurrence of nephrological events in a large monocentric cohort of patients treated with Immune Checkpoints Inhibitors in the Centre Hospitalier Lyon Sud. Nephrological parameters based on Serum Creatinine (SCr), estimate Glomerular Filtration Rate (eGFR) and urinary sediment are monitored. The aim of the study is to determine the incidence of renal events due to Immune Checkpoint Inhibitor treatment, particularly Acute Kidney Injury, (AKI) and identify the clinical presentation, histological description and risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •All patients treated by one of the Immune Checkpoints inhibitors (Nivolumab, Pembrolizumab, ipilimumab or Atezolizumab), for neoplastic pathology in dermatologic, pneumologic, or medical oncology department.
排除标准
- •Minor patients (less than 18y).
- •Refusal to consent.
- •For statistical analysis: Acute Renal Failure caused by another identified etiology than drug toxicity.
结局指标
主要结局
Incidence of Acute kidney Injury
时间窗: maximum 6 months
Acute kidney Injury is defined by the KDIGO (Kidney Disease: Improving Global Outcomes) recommendations by an increase in serum creatinine during follow-up of at least 1.5 times the baseline. Follow-up : Nephrological parameters will be notice during whole treatment duration, until interruption for medical reason (tumoral progression, severe adverse event) or end of the study (stop of the collection and analysis of the results); In this case, a 6-month follow-up period for patients undergoing treatment at the time of the collection of data.
次要结局
未报告次要终点