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Recruiting NCT05326399

Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

— Observational Liver Transplantation Renal Insufficiency, Chronic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: renal biospy.
Who it may be relevant to
Registry conditions: Liver Transplantation, Renal Insufficiency, Chronic. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Progression of renal function [Time frame: 96 weeks]
Secondary outcome measures (6)
  • Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy [Time frame: 96 weeks]
  • Pathology of kidney disease [Time frame: 96 weeks]
  • Patient survival in post-liver transplantation patients with renal impairment after renal biopsy [Time frame: 96 weeks]
  • Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy [Time frame: 96 weeks]
  • Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy. [Time frame: 96 weeks]
  • Effect of acute liver failure before liver trasplatation on renal impairment [Time frame: 96 weeks]

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 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)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
  • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai

Publications

  • Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744. PMID 12954741
  • Neau-Cransac M, Morel D, Bernard PH, Merville P, Revel P, Potaux L, Saric J. Renal failure after liver transplantation: outcome after calcineurin inhibitor withdrawal. Clin Transplant. 2002 Oct;16(5):368-73. doi: 10.1034/j.1399-0012.2002.02028.x. PMID 12225434
  • Welker MW, Weiler N, Bechstein WO, Herrmann E, Betz C, Schoffauer M, Zeuzem S, Sarrazin C, Amann K, Jung O. Key role of renal biopsy in management of progressive chronic kidney disease in liver graft recipients. J Nephrol. 2019 Feb;32(1):129-137. doi: 10.1007/s40620-018-0506-2. Epub 2018 Jun 26. PMID 29946864
  • Chan GS, Lam MF, Kwan L, Fung SH, Chan SC, Chan KW. Clinicopathological study of renal biopsies after liver transplantation. Hong Kong Med J. 2013 Feb;19(1):27-32. PMID 23378351
  • Lee JH, Cho YH, Ryu SJ, Kim SS, Lee YH, Jang IA, Choi BS, Choi JY, Kim DG, Choi YJ, Yang CW, Chung BH. Clinical usefulness of kidney biopsy in liver transplant recipients with renal impairment. Kidney Res Clin Pract. 2013 Dec;32(4):153-7. doi: 10.1016/j.krcp.2013.08.002. Epub 2013 Oct 24. PMID 26877934
  • Kim JY, Akalin E, Dikman S, Gagliardi R, Schiano T, Bromberg J, Murphy B, de Boccardo G. The variable pathology of kidney disease after liver transplantation. Transplantation. 2010 Jan 27;89(2):215-21. doi: 10.1097/TP.0b013e3181c353e5. PMID 20098285
  • O'Riordan A, Dutt N, Cairns H, Rela M, O'Grady JG, Heaton N, Hendry BM. Renal biopsy in liver transplant recipients. Nephrol Dial Transplant. 2009 Jul;24(7):2276-82. doi: 10.1093/ndt/gfp112. Epub 2009 Mar 16. PMID 19293134
  • Bennett WM. Insights into chronic cyclosporine nephrotoxicity. Int J Clin Pharmacol Ther. 1996 Nov;34(11):515-9. PMID 8937936

Identifiers

NCT: NCT05326399 · Renji20220326

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗