Epidemiology, Diagnosis, Medical Care and Prognosis of Tubulointerstitial Nephritis: Results of a Multicenter Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 6
- 主要终点
- Evolution of glomerular filtration rate and renal survival
研究概览
简要总结
Tubulointerstitial nephritis (TIN), diagnosed on kidney biopsy, represents a common cause of kidney failure. The etiologies are multiple but the diagnosis of the causative disease is sometimes difficult and the treatment is not completely codified.
The research focuses on the characterization of TIN on the etiological, clinical, biological, therapeutic and prognostic levels in order to improve patient care.
For this purpose, kidney biopsies performed for the diagnosis, kept in a biological collection within the biological resource platforms of the Necker-Enfants Malades hospital and the Georges Pompidou hospital will be centrally reviewed, blinded to the final diagnosis.
详细描述
Tubulointerstitial nephritis (TIN) is defined as a diverse set of renal pathologies caused by a primary lesion of the interstitial compartment, which most often extends to the associated tubular structures. Renal histology establishes the diagnosis by objectifying different types of lesions associated to varying degrees depending on the etiology and clinical course. These lesions are: an interstitial inflammatory infiltrate whose nature is largely dependent on the etiopathogenic mechanisms of the lesion, diffuse or multifocal interstitial fibrosis, tubular epithelial lesions in the form of tubulitis and/or tubular atrophy.
Research focuses on the characterization of TIN on the etiological, clinical, biological, therapeutic and prognostic levels in order to try to improve patient care. For this:
- 1st step: native kidney biopsies performed to establish the diagnosis and kept in a biological collection within the biological resource platforms of the Necker-Enfants Malades hospital and the Georges Pompidou hospital will be centrally reviewed The review will be performed at the Pathology department of Necker hospital, blinded to the final diagnosis for selection of the biopsies that will be included in the study. Included biopsies will be those with tubulointerstitial nephritis retained as the main cause of renal dysfunction after etiological investigation
- 2nd step: collection of clinical and biological data regarding the diagnosis, management and prognosis
- 3rd step: statistical analysis of the data and consolidation of the results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult patients who do not object to the use of their medical data and samples for this research
- •With a biopsy of the care on native kidney and subject to a biological collection, finding tubulointerstitial nephritis in the foreground and retained as the main cause of renal dysfunction after etiological investigation.
- •Signs of histological activity of the NTI objectified during the centralized rereading and defined by:
- •An inflammation of more than 10% of the surface of the entire cortical parenchyma (fibrous and non-fibrous) or a ti score > or = 1 according to the Banff classification
- •AND/OR the presence of at least one granuloma on the biopsy
排除标准
- •No access to medical records for data collection, or insufficient clinical data
- •Follow-up less than 3 months
- •Histological lesions of the tubulointerstitial sector but related to a hematological, urological, genetic etiology or the direct tubular toxicity of a drug
研究组 & 干预措施
Patients
Patients whose biopsy of the care revealed tubulointerstitial nephritis in the foreground and retained as the main cause of renal dysfunction after etiological investigation.
The biopsies concerned were carried out between 01/01/2010 and 31/12/2019. The clinical follow-up data of the patients from whom the biopsies were taken will be collected until the date of the last follow-up (before 31/12/2021).
干预措施: Rereading of biopsies (Other)
Patients
Patients whose biopsy of the care revealed tubulointerstitial nephritis in the foreground and retained as the main cause of renal dysfunction after etiological investigation.
The biopsies concerned were carried out between 01/01/2010 and 31/12/2019. The clinical follow-up data of the patients from whom the biopsies were taken will be collected until the date of the last follow-up (before 31/12/2021).
干预措施: Collection of data from the patient's medical file (Other)
结局指标
主要结局
Evolution of glomerular filtration rate and renal survival
时间窗: Time 0
Evolution of glomerular filtration rate and renal survival (defined as the persistence of sufficient renal function not requiring the use of a replacement technique) over time and according to etiology.
次要结局
- Significant association between renal prognosis with specific predictive factors(Time 0)
- Response to corticosteroid therapy(Time 0)
- Association between response to corticosteroid therapy and some histological criteria(Time 0)
- Evaluate the contribution of histological analysis in etiological diagnosis(Time 0)