Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

Recruiting

• Conditions: Renal Insufficiency, Chronic; Liver Transplantation
• Interventions: Behavioral: renal biospy

• Registration Number: NCT05326399
• Lead Sponsor: RenJi Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-26
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-13
• Study Start: 2022-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-05-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 369

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
renal biopsy	renal biospy	Standard percutaneous biopsy has been performed in all participants. Light microscope, fluorescence microscope and electron microscope were used for assessment of kidney issue

Primary Outcome Measures

Name	Time	Method
Progression of renal function	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)

Secondary Outcome Measures

Name	Time	Method
Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy	96 weeks	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.
Pathology of kidney disease	96 weeks	Describe the pathology of kidney disease in post-liver transplantation patients with renal impairment.
Patient survival in post-liver transplantation patients with renal impairment after renal biopsy	96 weeks	Describe the patient survival rate in post-liver transplantation patients with renal impairment after renal biopsy.
Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy	96 weeks	Describe the kidney survival rate in post-liver transplantation patients with renal impairment.
Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy.	96 weeks	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%)
Effect of acute liver failure before liver trasplatation on renal impairment	96 weeks	Investigate the effect of acute liver failure before liver trasplatation on renal impairment with subgroup analysis.

Trial Locations

Locations (1)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China