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

NCT01444079 | Completed DMC

• 1 other identifier: 4-2010-0808
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant Rejection

Keywords

Liver transplantation; Rejection; Tolerance

Outcome Measures

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 point when patients are diagnosed acute rejection

Secondary Outcomes (1)

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

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

Study Arms (1)

Liver transplant recipients

Recipients who will undergo liver transplantation during study period

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult recipients who will undergo liver transplantation during study period

You may qualify if:

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

You may not qualify if:

• Age under 20 years
• Multi-organ transplantation
• Not agree with informed consent
• Patient who had plant to be transferred to other country or center

Sponsors & Collaborators

• Yonsei University: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

• 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.

  PMID: 16146554 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Whole blood (serum)

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Myoung Soo Kim, M.D.

  Yonsei University College of Meidicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 30, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

KR (1)