NCT00527774

Brief Summary

The purpose of this study is to study whether hepatitis C virus (HCV)infected maintenance hemodialysis (MHD)patients have distinct metabolic, inflammatory and adipokine characteristics that can be linked to poor clinical outcome and to examine the hypothesis that HCV infected MHD patients with metabolic syndrome have higher risks for hospitalization, cardiovascular and all-cause mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2007

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

September 10, 2007

Last Update Submit

May 4, 2016

Conditions

Hepatitis CHemodialysisQuality of LifeMortalityHospitalization

Keywords

Hepatitis Cmalnutrition-inflammation complex syndrome (MICS)dialysismortalityhospitalizationhealth-related quality of life (HRQOL)peripheral arterial occlusive disease (PAOD)

Study Arms (2)

A

HCV(+) maintenance hemodialysis patients

B

HCV(-) maintenance hemodialysis patients

Eligibility Criteria

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

A cross-sectional study was conducted in one regional teaching hospital (St. Martin De Porres Hospital) in Chiayi City in Taiwan and its medical alliance dialysis clinics during Sept. 2007 to March 2008.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hemodialysis Center, St. Martin De Porres Hospital

Chiayi City, 60076, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Check HCV viral load and genotype in first month and sixth month

MeSH Terms

Conditions

Hepatitis CPeripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Chung-Jing Wang, M.D.

    St. Martin De Porres Hospital

    STUDY CHAIR

  • Kuan-Yu Hung, M.D. & Ph.D.

    Nephrology Section, Department of Internal Medicine, National Taiwan University and College of Medicine

    PRINCIPAL INVESTIGATOR

  • Pau-Chung Chen, M.D. & Ph.D.

    Institute of Occupational Medicine and Industrial Hygiene, College of Public Health, National Taiwan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 11, 2007

Study Start

September 1, 2007

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

May 5, 2016

Record last verified: 2016-05

Locations

TW(1)