Skip to content

Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients

The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02044588
Enrollment
100
Registered
2014-01-24
Start date
2000-01-31
Completion date
Unknown
Last updated
2014-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HBsAg(-) Donor Kidney Allograft, HBsAg(+) Donor Kidney Allograft

Keywords

HBsAg(+) donor, HBsAg(-) donor, Anti-hepatitis B antibody, Kidney allograft

Brief summary

To determine the safety of using kidney organ from hepatitis B surface antigen positive donor, the author conducted the single-center, prospective study of the use of these kidneys for recipients who have protective level of hepatitis B surface antibodies.

Detailed description

The kidney transplant registry was conducted in KCMH since the year of 2000 until the present. 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.

Interventions

BIOLOGICALHBsAg positive kidney allograft donor

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Hepatitis B transmission rateJanuary 2000 to December 2013The hepatitis B transmission rate was determined at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 by using: * Clinical data including jaundice, hepatitis, acute liver failure. * Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT. * Radiological data of liver ultrasonography.

Secondary

MeasureTime frameDescription
Graft survival rateJanuary 2000 to December 2013The graft survival rate was determined by Kaplan-Meyer survival analysis.

Other

MeasureTime frameDescription
Patient survival rateJanuary 2000 to December 2013The patient survival rate was determined by Kaplan-Meyer survival analysis.

Countries

Thailand

Contacts

Primary ContactWiwat Chancharoenthana, MD, MSc
wiwatmd@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026