Clinical trial NCT02044588: Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients
Official title: The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HBsAg(+) Donor Kidney Allograft
HBsAg(-) Donor Kidney Allograft
Keywords: HBsAg(+) donor
HBsAg(-) donor
Anti-hepatitis B antibody
Kidney allograft
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All kidney transplant recipients from January 1, 2000 until the present (upto year 2013) were prospective follow-up.

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.

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.

Primary outcomes:
measure: Hepatitis B transmission rate
timeFrame: January 2000 to December 2013
Secondary outcomes:
measure: Graft survival rate
timeFrame: January 2000 to December 2013
Other outcomes:
measure: Patient survival rate
timeFrame: January 2000 to December 2013
Locations:
city: Bangkok
country: Thailand
facility: Wiwat Chancharoenthana
Study officials:
affiliation: Chulalongkorn University
name: Wiwat Chancharoenthana, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chancharoenthana W, Townamchai N, Pongpirul K, Kittiskulnam P, Leelahavanichkul A, Avihingsanon Y, Suankratay C, Wattanatorn S, Kittikowit W, Praditpornsilpa K, Tungsanga K, Eiam-Ong S. The outcomes of kidney transplantation in hepatitis B surface antigen (HBsAg)-negative recipients receiving graft from HBsAg-positive donors: a retrospective, propensity score-matched study. Am J Transplant. 2014 Dec;14(12):2814-20. doi: 10.1111/ajt.12921. Epub 2014 Nov 13.