Liver Transplant RejectionNCT01444079
Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
An observational study of Liver Transplant Rejection, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Liver Transplant Rejection
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult recipients who will undergo liver transplantation during study period
Who may be able to join
- Liver recipients who undergo liver transplantation between Mar, 2011 and Feb, 2012
- Patients who can be followed for more than 3 months after transplantation
Who cannot join
- Age under 20 years
- Multi-organ transplantation
- Not agree with informed consent
- Patient who had plant to be transferred to other country or center
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Liver Transplant Rejection
- Keywords
- Liver transplantation, Rejection, Tolerance
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplant recipients | Recipients who will undergo liver transplantation during study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute rejection
We designed to analyze the aspects of acute rejection between anti-donor lymphocyte antibody change liver transplantation.
Measured: 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.
Measured: at 7 day, 14 day, 21 day after transplantation and at 3 month, 6 month after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Sponsor
- Investigators
- Myoung Soo Kim, M.D., Principal investigator, Yonsei University College of Meidicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444079
- Sponsor's protocol ID
- 4-2010-0808
- Status last verified
- Jan 2015
- First submitted
- 19 Sep 2011
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Rejection or Tolerance Affected by Serial Change of Anti-donor Lymphocyte Antibody After Liver Transplantation
- ClinicalTrials.gov ID
- NCT01444079
- Acronym / sponsor ID
- 4-2010-0808
- Conditions
- Liver Transplant Rejection
- Keywords
- Liver transplantation, Rejection, Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant recipients | – | –Recipients who will undergo liver transplantation during study period |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult recipients who will undergo liver transplantation during study period
Key inclusion criteria (2 listed)
- Liver recipients who undergo liver transplantation between Mar, 2011 and Feb, 2012
- Patients who can be followed for more than 3 months after transplantation
Key exclusion criteria (4 listed)
- Age under 20 years
- Multi-organ transplantation
- Not agree with informed consent
- Patient who had plant to be transferred to other country or center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
- Background: PubMed 16146554Matinlauri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myoung Soo Kim, M.D. principal investigator
Yonsei University College of Meidicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant Rejection, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of acute rejection (time frame: Time point when patients are diagnosed acute rejection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01444079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2015.