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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Biological: HBsAg positive kidney allograft donor


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HBsAg negative kidney allograft donor<br> | |
| HBsAg positive kidney allograft donor<br>HBsAg positive kidney allograft donor | Biological: HBsAg positive kidney allograft donor<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B transmission rate | 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. | January 2000 to December 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival rate | The graft survival rate was determined by Kaplan-Meyer survival analysis. | January 2000 to December 2013 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBsAg(+) donor, HBsAg(-) donor, Anti-hepatitis B antibody, Kidney allograft