Trial record 5 of 432 for:    Open Studies | "Tissue Donors"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Chulalongkorn University
Sponsor:
Information provided by (Responsible Party):
Wiwat Chancharoenthana, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT02044588
First received: January 20, 2014
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
HBsAg(+) Donor Kidney Allograft
HBsAg(-) Donor Kidney Allograft
Biological: HBsAg positive kidney allograft donor

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg

Resource links provided by NLM:


Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Hepatitis B transmission rate [ Time Frame: January 2000 to December 2013 ] [ Designated as safety issue: Yes ]

    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:
  • Graft survival rate [ Time Frame: January 2000 to December 2013 ] [ Designated as safety issue: No ]
    The graft survival rate was determined by Kaplan-Meyer survival analysis.


Other Outcome Measures:
  • Patient survival rate [ Time Frame: January 2000 to December 2013 ] [ Designated as safety issue: Yes ]
    The patient survival rate was determined by Kaplan-Meyer survival analysis.


Estimated Enrollment: 100
Study Start Date: January 2000
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HBsAg negative kidney allograft donor
HBsAg positive kidney allograft donor
HBsAg positive kidney allograft donor
Biological: HBsAg positive kidney allograft donor

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044588

Contacts
Contact: Wiwat Chancharoenthana, MD, MSc wiwatmd@hotmail.com

Locations
Thailand
Wiwat Chancharoenthana Recruiting
Bangkok, Thailand, 10330
Contact: Wiwat Chancharoenthana, MD, Msc       wiwatmd@hotmail.com   
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Wiwat Chancharoenthana, MD, MSc Chulalongkorn University
  More Information

No publications provided

Responsible Party: Wiwat Chancharoenthana, Division of Nephrology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02044588     History of Changes
Other Study ID Numbers: WWC-001
Study First Received: January 20, 2014
Last Updated: January 22, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
HBsAg(+) donor
HBsAg(-) donor
Anti-hepatitis B antibody
Kidney allograft

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis B Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014