Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Progression of renal function [Срок оценки: 96 weeks]

Вторичные конечные точки (6)

• Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy [Срок оценки: 96 weeks]
• Pathology of kidney disease [Срок оценки: 96 weeks]
• Patient survival in post-liver transplantation patients with renal impairment after renal biopsy [Срок оценки: 96 weeks]
• Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy [Срок оценки: 96 weeks]
• Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy. [Срок оценки: 96 weeks]
• Effect of acute liver failure before liver trasplatation on renal impairment [Срок оценки: 96 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай
• Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine — Шанхай

Публикации

• 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

Идентификаторы

NCT: NCT05326399 · Renji20220326

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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