Hepatorenal Syndrome, Liver RegenerationNCT07300709
Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation
A study testing renal biopsy in people with Hepatorenal Syndrome, Liver Regeneration and AKI - Acute Kidney Injury, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatorenal Syndrome, Liver Regeneration, AKI - Acute Kidney Injury, Liver Transplant
- What is being tested?
- renal biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 3-month post transplant renal biopsy exclusion criteria:
- Graft failure after LT
- Any condition deemed inappropriate by the PI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Queen Mary Hospital
Hong Kong
Tiffany Wong, +852 22553025, wongtcl@hku.hk
Tiffany Wong
About this study
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.
- Being tested
- renal biopsy
- Keywords
- Hepatorenal syndrome, HRS, HRS AKI, acute kidney injury, liver transplant, renal biopsy, renal histopathology, transcriptomics
- Medical subject headings
- Hepatorenal Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal biopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: renal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with HRS AKI
Proportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology
Measured: up to 3 years
Histopathological changes
Histopathological changes and their association with clinical parameters
Measured: up to 3 years
Secondary outcomes (5)
Duration of HRS AKI
Incidence and duration of HRS AKI
Measured: up to 3 years
Response to standard treatment (Terlipressin and albumin)
Response to standard treatment (Terlipressin and albumin)
Measured: up to 3 years
Perioperative morbidity
Perioperative morbidity including need and duration for renal replacement therapy
Measured: up to 3 years
Post-transplant renal recovery rates
Post-transplant renal recovery rates
Measured: up to 3 years
Transcriptomic signature differences
Transcriptomic signature differences between HRS AKI and non-HRS AKI patients
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatorenal Syndrome, Liver RegenerationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tiffany Cho-Lam Wong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300709
- Sponsor's protocol ID
- UW25-392
- Status last verified
- Dec 2025
- First submitted
- 2 Oct 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation
- ClinicalTrials.gov ID
- NCT07300709
- Acronym / sponsor ID
- UW25-392
- Keywords
- Hepatorenal syndrome, HRS, HRS AKI, acute kidney injury, liver transplant, renal biopsy, renal histopathology, transcriptomics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal biopsy | Experimental | Procedure: renal biopsyTo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Inability or unwillingness to give written informed consent
- Patient with known pre-existing renal disease
- Patient with solitary kidney
- Re-transplantation
- ABO-incompatible LT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal biopsyTo 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 or surgery | Renal biopsy |
Primary outcome
Proportion of patients with HRS AKI
Time frame: up to 3 years
Proportion of patients with HRS AKI who have normal, reversible or permanent injury on renal histopathology
Histopathological changes
Time frame: up to 3 years
Histopathological changes and their association with clinical parameters
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal biopsy in people with Hepatorenal Syndrome, Liver Regeneration and AKI - Acute Kidney Injury, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Wong (+852 22553025, wongtcl@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with HRS AKI (time frame: up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.