NCT02434445

Brief Summary

This study investigated the use of novel plasma and urinary biomarkers to predicte the development of hepatorenal syndrome in patients with advanced cirrhosis. The biomarkers investigated include plasma cystatin C, plasma NGAL, plasma NAG, plasma IL-18, plasma ADMA, plasma BTP, urinary KIM-1 and urinary LFABP. These biomarkers will be checked in advanced cirrhotic patients who have or have not developed hepatorenal syndrome and compared between the two groups. These biomarkers will also be correlated with the occurence of hepatorenal syndrome.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jun 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jun 2012Dec 2028

Study Start

First participant enrolled

June 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

16.6 years

First QC Date

April 30, 2015

Last Update Submit

December 13, 2024

Conditions

Hepatorenal Syndrome

Outcome Measures

Primary Outcomes (1)

  • Hepatorenal syndrome

    12 weeks

Secondary Outcomes (2)

  • Mortality

    6 months

  • Chronic renal impairment

    6 months

Study Arms (2)

Hepatorenal syndrome group

Patients with advanced cirrhosis who develope hepatorenal syndrome

Non-hepatorenal syndrome group

Patients with advanced cirrhosis who do not hepatorenal syndrome

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation

You may qualify if:

  • Patients with advanced cirrhosis (Child's B or C) referred for liver transplantation
  • Willing to give informed consent

You may not qualify if:

  • Patients with co-existing renal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital, Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

patient's serum and urine samples

MeSH Terms

Conditions

Hepatorenal Syndrome

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Desmond Yap, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Desmond Yap, MD

CONTACT

85222553879desmondy@hku.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

June 1, 2012

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations

HK(1)