NCT02044588

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
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	HBsAg positive kidney allograft donor

Timeline

• Start date: 2000-01-01
• Primary completion: 2014-12-01
• First posted: 2014-01-24
• Last updated: 2014-01-24

Locations

1 site across 1 country: Thailand