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

Liver Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444079
• Other study ID #: 4-2010-0808
• Status: Completed
• Phase: N/A
• First received: September 19, 2011
• Last updated: January 26, 2015
• Start date: April 2011
• Est. completion date: February 2014

Study information

• Verified date: January 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Transplant Rejection

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation	No