Use of Novel Plasma and Urinary Biomarkers to Predict the... | NCT02434445

Studies
Use of Novel Plasma and Urinary Biomarkers to Predict the Development of Hepatorenal Syndrome in Cirrhotic Patients

NCT02434445

Sponsor

The University of Hong Kong

Status

Recruiting

Last Update Posted

Dec 16, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatorenal Syndrome

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2012Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2024

Last Update Posted Date

Dec 16, 2024Actual

Name	Class
The Hong Kong Society of Nephrology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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 tested 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatorenal syndrome group		Patients with advanced cirrhosis who develope hepatorenal syndrome
Non-hepatorenal syndrome group		Patients with advanced cirrhosis who do not hepatorenal syndrome

Interventions

Not provided

Measure	Description	Time Frame
Hepatorenal syndrome		12 weeks

Measure	Description	Time Frame
Mortality		6 months
Chronic renal impairment		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with co-existing renal diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Desmond Yap, MD	Contact	85222553879		desmondy@hku.hk

Overall Officials

Name	Affiliation	Role
Desmond Yap, MD	The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital, Hong Kong	Recruiting	Hong Kong			Hong Kong

Condition Browse Module

MeSH Terms

ID	Term
D006530	Hepatorenal Syndrome

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided