Liver TransplantationNCT03147157
The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen After Liver Transplantation
A study testing tacrolimus regimen guided by HLA matching rate in people with Liver Transplantation and Graft Versus Host Disease, run by The First Hospital of Jilin University.
Trial summary
The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation, Graft Versus Host Disease, Graft Rejection
- What is being tested?
- tacrolimus regimen guided by HLA matching rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Apr 2025
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients signed informed consent，patients with good compliance
Who cannot join
- autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation
About this study
Official title: The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen
The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.
Read the detailed description
Liver transplantation is the most effective treatment for end-stage liver disease, yet long term survival is limited by acute and chronic rejection reaction and adverse reactions caused by immune inhibitors. However, effective guideline of immune inhibitors regimen after liver transplantation is lacking. Human major histocompatibility antigens (HLA) is crucial in renal transplantation, while the role in liver transplantation is unclear. It is reported that HLA matching was closely related to the occurrence of graft versus host disease (GVHD) after liver transplantation. And by reducing or removing the immune inhibitors can change the course of illness, improve prognosis, at the same time conduce to induce immune tolerance. Therefore, the investigators have the reason to believe that HLA matching rate has closely association with postoperative immune status of patients after liver transplantation, which may guide immune inhibitors regimen. The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.
- Conditions
- Liver Transplantation, Graft Versus Host Disease, Graft Rejection, Drug-Related Side Effects and Adverse Reactions
- Being tested
- tacrolimus regimen guided by HLA matching rate
- Keywords
- tacrolimus, histocompatibility antigens
- Medical subject headings
- Graft vs Host Disease, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus regimen guided by HLA matching rateOther
required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
| Study group | Role | What they receive |
|---|---|---|
| research group,low MR group | Experimental | tacrolimus regimen guided by HLA matching rate Receives: Other: tacrolimus regimen guided by HLA matching rate |
| observation group,low MR group | No intervention | tacrolimus regimen is applied according to clinical experience |
| research group,middle MR group | Experimental | tacrolimus regimen guided by HLA matching rate Receives: Other: tacrolimus regimen guided by HLA matching rate |
| observation group,middle MR group | No intervention | tacrolimus regimen is applied according to clinical experience |
| research group,high MR group | Experimental | tacrolimus regimen guided by HLA matching rate Receives: Other: tacrolimus regimen guided by HLA matching rate |
| observation group,high MR group | No intervention | tacrolimus regimen is applied according to clinical experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Possibility of tacrolimus regimen guided by HLA matching rate
Changes of liver function and incidence of acute rejection early after liver transplantation
Measured: 3 months
Secondary outcomes (4)
Occurrence rate of GVHD
Occurrence rate of GVHD between the different groups
Measured: 5 years
Occurrence time of adverse reactions caused by immune inhibitors
Occurrence time of adverse reactions caused by immune inhibitors between the different groups
Measured: 5 years
Degree of adverse reactions caused by immune inhibitors
Degree of adverse reactions caused by immune inhibitors between the different groups
Measured: 5 years
Patient survival rate
Patient survival rate between the different groups
Measured: 1-year,3-year and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startMay 2017 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoyue Lv, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147157
- Sponsor's protocol ID
- LCPYJJ2017007
- Status last verified
- May 2017
- First submitted
- 27 Apr 2017
- Last updated
- 12 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Human Leukocyte Antigen Macthing on Guiding Tacrolimus Regimen
- ClinicalTrials.gov ID
- NCT03147157
- Acronym / sponsor ID
- LCPYJJ2017007
- Conditions
- Liver Transplantation, Graft Versus Host Disease, Graft Rejection, Drug-Related Side Effects and Adverse Reactions
- Keywords
- tacrolimus, histocompatibility antigens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.
Detailed description
Liver transplantation is the most effective treatment for end-stage liver disease, yet long term survival is limited by acute and chronic rejection reaction and adverse reactions caused by immune inhibitors. However, effective guideline of immune inhibitors regimen after liver transplantation is lacking. Human major histocompatibility antigens (HLA) is crucial in renal transplantation, while the role in liver transplantation is unclear. It is reported that HLA matching was closely related to the occurrence of graft versus host disease (GVHD) after liver transplantation. And by reducing or removing the immune inhibitors can change the course of illness, improve prognosis, at the same time conduce to induce immune tolerance. Therefore, the investigators have the reason to believe that HLA matching rate has closely association with postoperative immune status of patients after liver transplantation, which may guide immune inhibitors regimen. The aim of this research is to design a randomized controlled clinical study, which is based on HLA matching rate to guide tacrolimus regimen. In this study, the possibility of tacrolimus regimen guided by HLA matching rate will be explored, the occurrence rate of GVHD and rejection reaction will be observed, and the occurrence time and degree of adverse reactions caused by immune inhibitors will be identified. In the meantime, providing a possible prospect for prevention of GVHD and reduction or removal of immune inhibitors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| research group,low MR group | Experimental | Other: tacrolimus regimen guided by HLA matching ratetacrolimus regimen guided by HLA matching rate |
| observation group,low MR group | No intervention | –tacrolimus regimen is applied according to clinical experience |
| research group,middle MR group | Experimental | Other: tacrolimus regimen guided by HLA matching ratetacrolimus regimen guided by HLA matching rate |
| observation group,middle MR group | No intervention | –tacrolimus regimen is applied according to clinical experience |
| research group,high MR group | Experimental | Other: tacrolimus regimen guided by HLA matching ratetacrolimus regimen guided by HLA matching rate |
| observation group,high MR group | No intervention | –tacrolimus regimen is applied according to clinical experience |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients signed informed consent，patients with good compliance
Key exclusion criteria (1 listed)
- autoimmune liver disease,ABO incompatibility,combined organ transplantation,re-transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tacrolimus regimen guided by HLA matching raterequired low,middle and high tacrolimus concentration in high,middle and low MR group respectively | Other | research group,high MR group, research group,low MR group, research group,middle MR group |
Primary outcome
Possibility of tacrolimus regimen guided by HLA matching rate
Time frame: 3 months
Changes of liver function and incidence of acute rejection early after liver transplantation
4 secondary outcomes
Occurrence rate of GVHD
Time frame: 5 years
Occurrence time of adverse reactions caused by immune inhibitors
Time frame: 5 years
Degree of adverse reactions caused by immune inhibitors
Time frame: 5 years
Patient survival rate
Time frame: 1-year,3-year and 5-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tacrolimus regimen guided by HLA matching rate in people with Liver Transplantation and Graft Versus Host Disease, run by The First Hospital of Jilin University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Possibility of tacrolimus regimen guided by HLA matching rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.