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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of HRS AKI | Incidence and duration of HRS AKI | up to 3 years |
| Response to standard treatment (Terlipressin and albumin) | Response to standard treatment (Terlipressin and albumin) |
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Inclusion Criteria:
3-month post transplant renal biopsy inclusion criteria:
Exclusion Criteria:
3-month post transplant renal biopsy exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Wong | Contact | +852 22553025 | wongtcl@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2025 | Oct 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006530 | Hepatorenal Syndrome |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| up to 3 years |
| Perioperative morbidity | Perioperative morbidity including need and duration for renal replacement therapy | up to 3 years |
| Post-transplant renal recovery rates | Post-transplant renal recovery rates | up to 3 years |
| Transcriptomic signature differences | Transcriptomic signature differences between HRS AKI and non-HRS AKI patients | up to 3 years |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |