Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

NCT ID: NCT05326399

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

369 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2030-12-31

Brief Summary

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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

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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.

Conditions

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Liver Transplantation Renal Insufficiency, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

renal biospy

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shan Mou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status NOT_YET_RECRUITING

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shan Mou, Dr

Role: CONTACT

13918221242

Haijiao Jin, Dr

Role: CONTACT

13917735313

Facility Contacts

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Shan Mou, Dr

Role: primary

13918221242

Haijiao Jin, Dr

Role: backup

13917735313

Haijiao Jin, Dr

Role: primary

+8613917735313

References

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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.

Reference Type BACKGROUND
PMID: 20098285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19293134 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8937936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15816895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12954741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12225434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29946864 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23378351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26877934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24767353 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27479161 (View on PubMed)

Other Identifiers

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Renji20220326

Identifier Type: -

Identifier Source: org_study_id

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