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Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

This study is currently recruiting participants.
Verified February 2012 by Yonsei University
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01444079
First received: September 19, 2011
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

Liver is an organ that is well-known for its immune tolerant capacity. However, there were still controversial issues about the impact of immunologic challenge after liver transplantation on the graft function. Different results of graft function affected by immunologic factors such as pre-transplant panel reactive antibody (PRA) status, pre-transplant positive lymphocyte cross match (LCM), or post-transplant circulating donor specific antibody (DSA) has been reported according to individual institutes. There was no trial for presenting anti-donor lymphocyte antibody change after liver transplantation.

The investigators designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode. Also, the investigators will find aspects of anti-donor lymphocyte antibody change after liver transplantation.


Condition
Liver Transplant Rejection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • incidence of acute rejection [ Time Frame: Time point when patients are diagnosed acute rejection ] [ Designated as safety issue: No ]
    We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.


Secondary Outcome Measures:
  • correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival [ Time Frame: at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation ] [ Designated as safety issue: No ]
    We designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode.


Biospecimen Retention:   None Retained

Whole blood (serum)


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Liver transplant recipients
Recipients who will undergo liver transplantation during study period

Detailed Description:

Study Design: Target study population is forty patients who will undergo liver transplantation for 1 year in YUHS. Pediatric and early mortality cases will be excluded. Blood sample will be collected at pre-transplant period, post-transplant 7, 14, 21 day, 3 month and 6 month.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult recipients who will undergo liver transplantation during study period

Criteria

Inclusion Criteria:

  • Liver recipients who undergo liver transplantation between Mar, 2011 and Feb, 2012
  • Patients who can be followed for more than 3 months after transplantation

Exclusion Criteria:

  • Age under 20 years
  • Multi-organ transplantation
  • Not agree with informed consent
  • Patient who had plant to be transferred to other country or center
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444079

Contacts
Contact: Myoung Soo Kim, MD, PhD 82-2-2228-2123 ysms91@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Dong Jin Joo     82-2-2228-2105     djjoo@yuhs.ac    
Sponsors and Collaborators
Yonsei University
Astellas Pharma Korea, Inc.
Investigators
Principal Investigator: Myoung Soo Kim, M.D. Yonsei University College of Meidicine
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01444079     History of Changes
Other Study ID Numbers: 4-2010-0808
Study First Received: September 19, 2011
Last Updated: February 2, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Liver transplantation
Rejection
Tolerance

ClinicalTrials.gov processed this record on May 23, 2013