CClinicalTrials.gg
CompletedNCT01444079Updated Jan 27, 2015

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

An observational study in Liver Transplant Rejection, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-01-27.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
48
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Transplant Rejection

Keywords

  • Liver transplantation
  • Rejection
  • Tolerance
03

In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult recipients who will undergo liver transplantation during study period

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
48 participants (actual)
Biospecimen retention
None retained

Groups and cohorts

  • Liver transplant recipients

    Recipients who will undergo liver transplantation during study period

06

What researchers measure

Primary outcomes

  1. incidence of acute rejection

    We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.

    Time frame: Time point when patients are diagnosed acute rejection

Secondary outcomes

  1. correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival

    We designed this study to analyze the correlation between pre- and post-transplant immune status (PRA, LCM), and graft survival / rejection episode.

    Time frame: at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation

07

Study locations

1 site
  • Severance Hospital
    Seoul, 120-752, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 16146554 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01444079
Lead sponsor
Yonsei University
Collaborators
Astellas Pharma Korea, Inc.
Responsible party
Sponsor
First posted
Sep 30, 2011
Start date
Apr 2011
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Jan 27, 2015

Study contacts

Myoung Soo Kim, M.D.
principal investigator · Yonsei University College of Meidicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion