Renal Biopsies in Post-liver Transplantation Patients With Renal Impairment

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326399
• Other study ID #: Renji20220326
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: RenJi Hospital
• Contact: Shan Mou, Dr
• Phone: 13918221242
• Email: shan_mou[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 369
• Est. completion date: December 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai
China	Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk factors of renal function deterioration in post-liver transplantation with renal impairment after renal biopsy	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
Secondary	Pathology of kidney disease	Describe the pathology of kidney disease in post-liver transplantation patients with renal impairment.	96 weeks
Secondary	Patient survival in post-liver transplantation patients with renal impairment after renal biopsy	Describe the patient survival rate in post-liver transplantation patients with renal impairment after renal biopsy.	96 weeks
Secondary	Kidney survival in post-liver transplantation patients with renal impairment after renal biopsy	Describe the kidney survival rate in post-liver transplantation patients with renal impairment.	96 weeks
Secondary	Remission of renal disease in post-liver transplantation patients with renal impairment after renal bisopy.	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
Secondary	Effect of acute liver failure before liver trasplatation on renal impairment	Investigate the effect of acute liver failure before liver trasplatation on renal impairment with subgroup analysis.	96 weeks