Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment: a Single-center, Prospective Cohort Study

Conditions
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Liver Transplantation, Renal Insufficiency, Chronic

Intervention / Treatment
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* Behavioral: renal biospy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 at least two occasions have received renal biopsy in the past 3 months Signed informed consent form(ICF) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| renal biopsy<br>Standard percutaneous biopsy has been performed in all participants. Light microscope, fluorescence microscope and electron microscope were used for assessment of kidney issue | Behavioral: renal biospy<br>* Standard percutaneous biopsy has been performed in all participants. Modification of treatment will be jointly decided by hepatologists and nephrologists based on the pathological results. All participants will be followed up for 96 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of renal function | 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) | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy | Investigate the risk factors of renal function deterioration in post-liver transplantation patients with renal impairment after renal biospy. Renal function deterioration is defined as a composite of ESRD or >100% increase of Scr or >50% per year decline of eGFR. | 96 weeks | 
| Pathology of kidney disease | Describe the pathology of kidney disease in post-liver transplantation patients with renal impairment. | 96 weeks | 
| Patient survival in post-liver transplantation patients with renal impairment after renal biopsy | Describe the patient survival rate 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 | Describe the kidney survival rate in post-liver transplantation patients with renal impairment. | 96 weeks | 
| Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy. | To describe the remission rate of renal disease in post-liver transplantation patients with renal impairment after renal biopsy. Remission is defined as 24-hour proteinuria decrease to <0.3g/24h or <50%of baseline, with stable kidney function(eGFR decrease less than 15%) | 96 weeks | 
| Effect of acute liver failure before liver trasplatation on renal impairment | Investigate the effect of acute liver failure before liver trasplatation on renal impairment with subgroup analysis. | 96 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplantation, renal biopsy, chronic kidney disease