Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients
NCT ID: NCT02044588
Last Updated: 2014-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2000-01-31
Brief Summary
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Detailed Description
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The inclusion criterion was:
* All kidney allograft recipients who received at least one month after transplantation.
* All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.
The exclusion criterion was:
* The recipients with positive hepatitis C virus antibody.
* The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
* The recipients those lost to follow-up.
Study group:
* The recipients who received kidney allograft from the HBsAg(+) donor.
Control group:
* The recipients who received kidney allograft from the HBsAg(-) donor.
According to the Thai Red Cross National Organ Donation and our institute's policy, the HBsAg(+) kidney allografts were distributed to only and informed consent.
Data collection:
* Baseline characteristic data e.g. donor and recipient age, donor and recipient gender, HLA, PRA, anti-HBs titer, immunity against HBV status (both natural and vaccinated),immunosuppressive regimens were collected.
* The recipients were prospective followed up at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120.
* Clinical data including jaundice, hepatitis, graft rejection were collected
* Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT, eGFR were collected.
* Pathological data of allograft biopsy at month 12 and 24 were retrieved.
Outcomes:
* Primary outcome: hepatitis B transmission rate.
* Secondary outcome: graft survival, patient survival.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HBsAg negative kidney allograft donor
No interventions assigned to this group
HBsAg positive kidney allograft donor
HBsAg positive kidney allograft donor
HBsAg positive kidney allograft donor
Interventions
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HBsAg positive kidney allograft donor
Eligibility Criteria
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Inclusion Criteria
* All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.
The exclusion criterion was:
* The recipients with positive hepatitis C virus antibody.
* The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
* The recipients those lost to follow-up.
18 Years
65 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Wiwat Chancharoenthana
Division of Nephrology, Department of Medicine, Faculty of Medicine
Principal Investigators
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Wiwat Chancharoenthana, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Chulalongkorn University
Locations
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Wiwat Chancharoenthana
Bangkok, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Chancharoenthana W, Townamchai N, Pongpirul K, Kittiskulnam P, Leelahavanichkul A, Avihingsanon Y, Suankratay C, Wattanatorn S, Kittikowit W, Praditpornsilpa K, Tungsanga K, Eiam-Ong S. The outcomes of kidney transplantation in hepatitis B surface antigen (HBsAg)-negative recipients receiving graft from HBsAg-positive donors: a retrospective, propensity score-matched study. Am J Transplant. 2014 Dec;14(12):2814-20. doi: 10.1111/ajt.12921. Epub 2014 Nov 13.
Other Identifiers
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WWC-001
Identifier Type: -
Identifier Source: org_study_id
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