HBsAg(-) Donor Kidney Allograft, HBsAg(+) Donor Kidney Allograft
Conditions
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Hepatitis B transmission rate | January 2000 to December 2013 | The 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
| Measure | Time frame | Description |
|---|---|---|
| Graft survival rate | January 2000 to December 2013 | The graft survival rate was determined by Kaplan-Meyer survival analysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient survival rate | January 2000 to December 2013 | The patient survival rate was determined by Kaplan-Meyer survival analysis. |
Countries
Thailand