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

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ClinicalTrials.gov Identifier: NCT01444079
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : January 27, 2015
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Yonsei University

September 19, 2011
September 30, 2011
January 27, 2015
April 2011
February 2014   (Final data collection date for primary outcome measure)
incidence of acute rejection [ Time Frame: Time point when patients are diagnosed acute rejection ]
We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.
Same as current
Complete list of historical versions of study NCT01444079 on ClinicalTrials.gov Archive Site
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 ]
We designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode.
Same as current
Not Provided
Not Provided
 
Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
Whole blood (serum)
Non-Probability Sample
Adult recipients who will undergo liver transplantation during study period
Liver Transplant Rejection
Not Provided
Liver transplant recipients
Recipients who will undergo liver transplantation during study period
Matinlauri IH, Höckerstedt KA, Isoniemi HM. Equal overall rejection rate in pre-transplant flow-cytometric cross-match negative and positive adult recipients in liver transplantation. Clin Transplant. 2005 Oct;19(5):626-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
40
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01444079
4-2010-0808
Yes
Not Provided
Not Provided
Yonsei University
Yonsei University
Astellas Pharma Korea, Inc.
Principal Investigator: Myoung Soo Kim, M.D. Yonsei University College of Meidicine
Yonsei University
January 2015