Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

NCT ID: NCT07300709

Last Updated: 2025-12-24

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

renal biopsy

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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


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


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Tiffany Cho-Lam Wong

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Tiffany Wong

Role: CONTACT

Phone: +852 22553025

Email: [email protected]

Facility Contacts

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Tiffany Wong

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UW25-392

Identifier Type: -

Identifier Source: org_study_id