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Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07300709
Enrollment
42
Registered
2025-12-24
Start date
2026-01-01
Completion date
2028-12-31
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

PROCEDURErenal 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

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with HRS AKIup to 3 yearsProportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology
Histopathological changesup to 3 yearsHistopathological changes and their association with clinical parameters

Secondary

MeasureTime frameDescription
Perioperative morbidityup to 3 yearsPerioperative morbidity including need and duration for renal replacement therapy
Duration of HRS AKIup to 3 yearsIncidence and duration of HRS AKI
Transcriptomic signature differencesup to 3 yearsTranscriptomic signature differences between HRS AKI and non-HRS AKI patients
Post-transplant renal recovery ratesup to 3 yearsPost-transplant renal recovery rates
Response to standard treatment (Terlipressin and albumin)up to 3 yearsResponse to standard treatment (Terlipressin and albumin)

Countries

Hong Kong

Contacts

Primary ContactTiffany Wong
wongtcl@hku.hk+852 22553025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026