Clinical trial NCT01444079: Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
Official title: Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant Rejection
Keywords: Liver transplantation
Rejection
Tolerance
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2011-09-30
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult recipients who will undergo liver transplantation during study period

Brief summary: 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.

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 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

Primary outcomes:
measure: incidence of acute rejection
timeFrame: Time point when patients are diagnosed acute rejection
Secondary outcomes:
measure: correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival
timeFrame: at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Yonsei University College of Meidicine
name: Myoung Soo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matinlauri IH, Hockerstedt 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. doi: 10.1111/j.1399-0012.2005.00364.x.