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

• Conditions: HBsAg(+) Donor Kidney Allograft; HBsAg(-) Donor Kidney Allograft
• Interventions: Biological: HBsAg positive kidney allograft donor

• Registration Number: NCT02044588
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Study Start: 2000-01
• Status Verified: 2014-01
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-22
• Last Update Submitted: 2014-01-22
• Study First Posted: 2014-01-24
• Last Update Posted: 2014-01-24
• Primary Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBsAg positive kidney allograft donor	HBsAg positive kidney allograft donor	HBsAg positive kidney allograft donor

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Graft survival rate	January 2000 to December 2013	The graft survival rate was determined by Kaplan-Meyer survival analysis.

Trial Locations

Locations (1)

Wiwat Chancharoenthana; 🇹🇭 Bangkok, Thailand