Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

Hepatorenal Syndrome (HRS) is a serious complication that can occur in patients with liver cirrhosis, characterised by kidney dysfunction, or acute kidney failure (AKI). While it has traditionally been thought that HRS affects structurally normal kidneys and is completely reversible with liver transplantation, recent evidence suggests this may not always be the case.

The purpose of this study is to examine the actual structural changes in the kidneys of patients with HRS through tissue biopsy and advanced molecular analysis. This may help us better understand the disease mechanism and potentially improve treatment approaches. We aim to challenge the current understanding that HRS always occurs in structurally normal kidneys and is always reversible after liver transplantation. This study will provide valuable insights into the pathophysiology of HRS and may lead to improved diagnostic and treatment strategies in the future.

This is a 3-year single center prospective, non-randomised, open label study at Queen Mary Hospital, The University of Hong Kong. All consecutive patients accepted on the liver transplant waiting list will be invited to participate. Patient will undergo several procedures related to liver transplant and kidney assessment, and receive liver transplantation and renal biopsy.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplant; Hepatorenal Syndrome, Liver Regeneration; AKI - Acute Kidney Injury
• Intervention / Treatment: Procedure: renal biopsy

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tiffany Wong; Phone Number: +852 22553025; Email: wongtcl@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
    • Contact: Tiffany Wong; Phone Number: +852 22553025; Email: wongtcl@hku.hk
    • Principal Investigator: Tiffany Wong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient must be able to understand and provide informed consent
2. Age ≥ 18 years of age at time of study entry
3. Accepted for liver transplantation (LT)
4. Fulfill the diagnostic criteria of HRS AKI according to International Club of Ascites (ICA) guidelines

3-month post transplant renal biopsy inclusion criteria:

1. Patient with adequate intraoperative renal biopsy
2. Patient must be able to understand and provide informed consent

Exclusion Criteria:

1. Inability or unwillingness to give written informed consent
2. Patient with known pre-existing renal disease
3. Patient with solitary kidney
4. Re-transplantation
5. ABO-incompatible LT
6. Fail to provide 3-month post transplant renal biopsy

3-month post transplant renal biopsy exclusion criteria:

1. Graft failure after LT
2. Any condition deemed inappropriate by the PI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal biopsy; To examine the actual structural changes in kidneys of patients with HRS through tissue biopsy and advanced molecular analysis, and hope that may help us better understand the disease mechanism and potentially improve treatment approaches	Procedure: renal biopsy; To examine the actual structural changes in kidneys of patients with HRS through tissue biopsy and advanced molecular analysis, and hope that may help us better understand the disease mechanism and potentially improve treatment approaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with HRS AKI	Proportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology	up to 3 years
Histopathological changes	Histopathological changes and their association with clinical parameters	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of HRS AKI	Incidence and duration of HRS AKI	up to 3 years
Response to standard treatment (Terlipressin and albumin)	Response to standard treatment (Terlipressin and albumin)	up to 3 years
Perioperative morbidity	Perioperative morbidity including need and duration for renal replacement therapy	up to 3 years
Post-transplant renal recovery rates	Post-transplant renal recovery rates	up to 3 years
Transcriptomic signature differences	Transcriptomic signature differences between HRS AKI and non-HRS AKI patients	up to 3 years

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 2, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: acute kidney injury; liver transplant; Hepatorenal syndrome; transcriptomics; renal biopsy; HRS; HRS AKI; renal histopathology
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Diseases; Liver Diseases; Renal Insufficiency; Acute Kidney Injury; Hepatorenal Syndrome
• Other Study ID Numbers: UW25-392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No