Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Spatial lipidomics for measuring tubular dysmetabolism
研究概览
简要总结
The project is to explore in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies.
详细描述
Patients with ANCA vasculitis with rapidly progressive glomerulonephritis with "crescent" will be compared to six other groups made up of patients with another nephropathy 1/extramembranous glomerulonephritis and 2/ nephropathy with minimal glomerular lesion (LGM) characterized by the absence of significant tubulointerstitial fibrosis lesions and slow evolution towards end-stage chronic renal failure ). Other groups of patients will 3/have interstitial nephropathy, 4/IgA mesangial glomerulopathy , 5/diabetic nephropathy, or 6/collapsing focal segmental hyalinosis.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for initial diagnostic PBR on native kidney
- •18 ans ≥ Age ≤ 90 ans
- •Affiliation to french health insurance
- •Patient having given consent
- •For the ANCA vasculitis group:
- •Diagnosis of ANCA vasculitis retained on renal biopsy with ANCA anti-proteinase 3 (PR3) or ANCA anti-myeloperoxidase (MPO)
- •For the control groups:
- •Diagnosis retained after the renal biopsy
- •Interstitial Nephritis
- •Or glomerular nephropathy such as minimal change nephropathy
- •Or Segmental hyalinosis in itscollapsing form
- •Or Extramembranous Glomerulopathy,
- •Or glomerulopathy with mesangial IgA deposits
- •Or diabetic nephropathy.
排除标准
- •Kidney transplant patient
- •Patient on dialysis (hemodialysis or peritoneal dialysis)
- •Patient under legal protection, guardianship or curatorship
- •Pregnancy or breastfeeding
- •Enrollement in an interventional study except studies relating to ANCA vasculitis and nephropathy with mesangial IgA deposits.
结局指标
主要结局
Spatial lipidomics for measuring tubular dysmetabolism
时间窗: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Their contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.
Spatial transcriptomics (at the mRNA level) for measuring peroxisome Proliferator-Activated Receptor-Gamma (PPAR-gamma)
时间窗: Through study completion up to end of study, when the last patients completed 1 year follow-up
Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Its contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.
Co-staining for measuring tubular segments markers
时间窗: Through study completion up to end of study, when the last patients completed 1 year follow-up
Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Their contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.
Immunofluorescence (at the protein level) for measuring peroxisome Proliferator-Activated Receptor-Gamma (PPAR-gamma)
时间窗: Through study completion up to end of study, when the last patients completed 1 year follow-up
Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Its contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.
次要结局
- Urinary protein/creatinine ratio evolution(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- Metabolomic analysis(Through study from baseline until one year visit.)
- Lipidomic analysis(Through study from baseline until one year visit.)
- Proportion of fibrotic tissues(At baseline.)
- Capillary density(At baseline.)
- Markers of podocytes, renal epithelial cells and specific leukocyte populations(At baseline.)
- Quantification of fibrosis(At baseline.)
- Transcriptomic analysis(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- IMC (imaging mass cytometry)(At baseline.)
- Glomerular filtration rate evolution(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- Urinary albumin/creatinine evolution ratio(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- Systole(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- Diastole(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- Heart rate(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- Blood count analysis(Through study completion up to end of study, when the last patients completed 1 year follow-up.)
- Leukocytes evolution(Through study completion up to end of study, when the last patients completed 1 year follow-up.)