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Not yet recruiting NCT07300709

Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

No phase Interventional Hepatorenal Syndrome, Liver Regeneration AKI - Acute Kidney Injury Liver Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: renal biopsy.
Who it may be relevant to
Registry conditions: Hepatorenal Syndrome, Liver Regeneration, AKI - Acute Kidney Injury, Liver Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

Primary outcome measures

  • Proportion of patients with HRS AKI [Time frame: up to 3 years]
  • Histopathological changes [Time frame: up to 3 years]
Secondary outcome measures (5)
  • Duration of HRS AKI [Time frame: up to 3 years]
  • Response to standard treatment (Terlipressin and albumin) [Time frame: up to 3 years]
  • Perioperative morbidity [Time frame: up to 3 years]
  • Post-transplant renal recovery rates [Time frame: up to 3 years]
  • Transcriptomic signature differences [Time frame: up to 3 years]

Eligibility criteria

Inclusion criteria

  • 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

3-month post transplant renal biopsy inclusion criteria:

  • Patient with adequate intraoperative renal biopsy
  • Patient must be able to understand and provide informed consent

Exclusion criteria

  • 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

3-month post transplant renal biopsy exclusion criteria:

  • Graft failure after LT
  • Any condition deemed inappropriate by the PI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Hong Kong · 1 center
  • Queen Mary Hospital — Hong Kong

Identifiers

NCT: NCT07300709 · UW25-392

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗