Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients
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|ClinicalTrials.gov Identifier: NCT02044588|
Recruitment Status : Unknown
Verified January 2014 by Wiwat Chancharoenthana, Chulalongkorn University.
Recruitment status was: Recruiting
First Posted : January 24, 2014
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment|
|HBsAg(+) Donor Kidney Allograft HBsAg(-) Donor Kidney Allograft||Biological: HBsAg positive kidney allograft donor|
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.
- The recipients who received kidney allograft from the HBsAg(+) donor.
- 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.
- 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.
- Primary outcome: hepatitis B transmission rate.
- Secondary outcome: graft survival, patient survival.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg|
|Study Start Date :||January 2000|
|Estimated Primary Completion Date :||December 2014|
|HBsAg negative kidney allograft donor|
HBsAg positive kidney allograft donor
HBsAg positive kidney allograft donor
|Biological: HBsAg positive kidney allograft donor|
- Hepatitis B transmission rate [ Time Frame: 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.
- Graft survival rate [ Time Frame: January 2000 to December 2013 ]The graft survival rate was determined by Kaplan-Meyer survival analysis.
- Patient survival rate [ Time Frame: January 2000 to December 2013 ]The patient survival rate was determined by Kaplan-Meyer survival analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02044588
|Contact: Wiwat Chancharoenthana, MD, MScemail@example.com|
|Bangkok, Thailand, 10330|
|Contact: Wiwat Chancharoenthana, MD, Msc firstname.lastname@example.org|
|Principal Investigator:||Wiwat Chancharoenthana, MD, MSc||Chulalongkorn University|