Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

NCT07300709 | Not Yet Recruiting

• 1 other identifier: UW25-392
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AKI - Acute Kidney Injury; Liver Transplant; Hepatorenal Syndrome, Liver Regeneration

Keywords

Hepatorenal syndrome; HRS; HRS AKI; acute kidney injury; liver transplant; renal biopsy; renal histopathology; transcriptomics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Duration of HRS AKI

  up to 3 years

• Response to standard treatment (Terlipressin and albumin)

  up to 3 years

• Perioperative morbidity

  up to 3 years

• Post-transplant renal recovery rates

  up to 3 years

• Transcriptomic signature differences

  up to 3 years

Study Arms (1)

Renal biopsy

EXPERIMENTAL

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

Interventions

renal biopsy PROCEDURE

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

Renal biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be able to understand and provide informed consent
• Age ≥ 18 years of age at time of study entry
• Accepted for liver transplantation (LT)
• Fulfill the diagnostic criteria of HRS AKI according to International Club of Ascites (ICA) guidelines
• Patient with adequate intraoperative renal biopsy
• Patient must be able to understand and provide informed consent

You may not qualify if:

• Inability or unwillingness to give written informed consent
• Patient with known pre-existing renal disease
• Patient with solitary kidney
• Re-transplantation
• ABO-incompatible LT
• Fail to provide 3-month post transplant renal biopsy
• Graft failure after LT
• Any condition deemed inappropriate by the PI

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hepatorenal Syndrome; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency

Central Study Contacts

Tiffany Wong

CONTACT

+852 22553025; wongtcl@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)