Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment: a Single-center, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Progression of renal function
研究概览
简要总结
Investigators will conduct this single-center, prospective cohort study to explore the prevalence and risk factors of renal function progression in post-liver transplantation patients with renal impairment after renal biospy and to understand the the pathology of kidney disease in post-liver transplantation patients with renal impairment.
详细描述
This is a single-center, prospective, cohort study. This study will include approximate 369 post-liver transplantation patients with renal impairment and have received renal biopsy. Demographic characteristics, medical history, etiology of liver failure, concomitant medications, baseline laboratory parameters, etc., will be recorded. All participants will receive standard treatment by hepatologists and nephrologists based on the pathological results. All participants will be followed up for 96 weeks. Renal function, concomitant medications, and other laboratory parameters, etc., will be obtained.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-75 years
- •patients received liver transplantation
- •new onset of proteinuria(defined as 24-hour proteinuria>1g/24h, or Urinary albumin creatinine ratio(UACR)>300mg/g on at least two occasions), and/or renal impairment: eGFR <60 mL/min/1.73 m² at least two occasions, and/or serum creatinine increase ≥50% from baseline
- •have received renal biopsy in the past 3 months
- •Signed informed consent form(ICF)
排除标准
- •patients received renal transplantation
- •hepatic failure
- •severe bleeding risk or platelet <70*109/L
- •chronic kidney insufficiency with eGFR<30ml/min·1.73m2,or kidney atrophy, or solitary kidney, or medullary sponge kidney, or polycystic kidney, or obstructive nephropathy
- •uncontrolled mental disease or unable to cooperate during operation
- •Pregnancy or lactation
- •not suitable for this study judged by investigaters
结局指标
主要结局
Progression of renal function
时间窗: 96 weeks
Describe the cumulative incidence of renal function progression in post-liver transplantation patients with renal impairment after renal biopsy. Renal function progression is defined as a composite of end-starge renal disease(ESRD) or \>100% increase of serum creatinine(Scr) or \>50% per year decline of estimated glomerular filtration rate (eGFR)
次要结局
- Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy(96 weeks)
- Pathology of kidney disease(96 weeks)
- Patient survival in post-liver transplantation patients with renal impairment after renal biopsy(96 weeks)
- Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy(96 weeks)
- Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy.(96 weeks)
- Effect of acute liver failure before liver trasplatation on renal impairment(96 weeks)