Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

November 24, 2023 updated by: Shan Mou, RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200127
        • Not yet recruiting
        • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shan Mou, Dr
        • Principal Investigator:
          • Jianjun Zhang, Dr
        • Sub-Investigator:
          • Qin Wang, Dr
        • Sub-Investigator:
          • Yongbing Qian, Dr
        • Sub-Investigator:
          • Haijiao Jin, Dr
        • Sub-Investigator:
          • Jiang Zhang, Dr
        • Sub-Investigator:
          • Yao Xu, Dr
      • Shanghai, China, 200127
        • Recruiting
        • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Shan Mou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients received liver transplantation with renal function and received renal biopsy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
renal biopsy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of renal function
Time Frame: 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)
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
Time Frame: 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.
96 weeks
Pathology of kidney disease
Time Frame: 96 weeks
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
Time Frame: 96 weeks
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
Time Frame: 96 weeks
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.
Time Frame: 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%)
96 weeks
Effect of acute liver failure before liver trasplatation on renal impairment
Time Frame: 96 weeks
Investigate the effect of acute liver failure before liver trasplatation on renal impairment with subgroup analysis.
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 13, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Renji20220326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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