Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

NCT05326399 | Recruiting

• 1 other identifier: Renji20220326
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 2

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.

Conditions

Liver Transplantation; Renal Insufficiency, Chronic

Keywords

Liver transplantation; renal biopsy; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Progression of renal function

  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 Outcomes (6)

• Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy

  96 weeks

• Pathology of kidney disease

  96 weeks

• Patient survival 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

  96 weeks

• Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy.

  96 weeks

Study Arms (1)

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

Interventions

renal biospy BEHAVIORAL

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.

renal biopsy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients received liver transplantation with renal function and received renal biopsy

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (2)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

NOT YET RECRUITING

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200127, China

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Bennett WM. Insights into chronic cyclosporine nephrotoxicity. Int J Clin Pharmacol Ther. 1996 Nov;34(11):515-9.

  PMID: 8937936 BACKGROUND

• Pillebout E, Nochy D, Hill G, Conti F, Antoine C, Calmus Y, Glotz D. Renal histopathological lesions after orthotopic liver transplantation (OLT). Am J Transplant. 2005 May;5(5):1120-9. doi: 10.1111/j.1600-6143.2005.00852.x.

  PMID: 15816895 BACKGROUND

• Fujinaga K, Usui M, Yamamoto N, Ishikawa E, Nakatani A, Kishiwada M, Mizuno S, Sakurai H, Tabata M, Isaji S. Hypertension and hepatitis C virus infection are strong risk factors for developing late renal dysfunction after living donor liver transplantation: significance of renal biopsy. Transplant Proc. 2014 Apr;46(3):804-10. doi: 10.1016/j.transproceed.2013.11.103.

  PMID: 24767353 BACKGROUND

• Pichler RH, Huskey J, Kowalewska J, Moiz A, Perkins J, Davis CL, Leca N. Kidney Biopsies May Help Predict Renal Function After Liver Transplantation. Transplantation. 2016 Oct;100(10):2122-8. doi: 10.1097/TP.0000000000001334.

  PMID: 27479161 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum and urine for laboratory examination

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shan Mou, Dr

CONTACT

13918221242; shan_mou@126.com

Haijiao Jin, Dr

CONTACT

13917735313; jinhaijiao1108@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 13, 2022
• Study Start: June 1, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)