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

Chulalongkorn University

Status: Unknown

Conditions: HBsAg(-) Donor Kidney Allograft; HBsAg(+) Donor Kidney Allograft

Treatments: Biological: HBsAg positive kidney allograft donor

Study type: Observational

Funder types: Other

Identifiers

NCT02044588

WWC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

100 participants in 2 patient groups

HBsAg negative kidney allograft donor

HBsAg positive kidney allograft donor

Description:

HBsAg positive kidney allograft donor

Treatment:

Biological: HBsAg positive kidney allograft donor