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

HBsAg(+) Donor Kidney Allograft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02044588
• Other study ID #: WWC-001
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2014
• Last updated: January 22, 2014
• Start date: January 2000

Study information

• Verified date: January 2014
• Source: Chulalongkorn University
• Contact: Wiwat Chancharoenthana, MD, MSc
• Email: wiwatmd[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Biological:
• HBsAg positive kidney allograft donor

Locations

Country	Name	City	State
Thailand	Wiwat Chancharoenthana	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient survival rate	The patient survival rate was determined by Kaplan-Meyer survival analysis.	January 2000 to December 2013	Yes
Primary	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	Yes
Secondary	Graft survival rate	The graft survival rate was determined by Kaplan-Meyer survival analysis.	January 2000 to December 2013	No