Clinical trial NCT05326399: Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment
Official title: Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment: a Single-center, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplantation
Renal Insufficiency, Chronic
Keywords: Liver transplantation
renal biopsy
chronic kidney disease
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients received liver transplantation with renal function and received renal biopsy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression of renal function
timeFrame: 96 weeks
Secondary outcomes:
measure: Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy
timeFrame: 96 weeks
measure: Pathology of kidney disease
timeFrame: 96 weeks
measure: Patient survival in post-liver transplantation patients with renal impairment after renal biopsy
timeFrame: 96 weeks
measure: Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy
timeFrame: 96 weeks
measure: Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy.
timeFrame: 96 weeks
measure: Effect of acute liver failure before liver trasplatation on renal impairment
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References:
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