Liver Transplant RejectionNCT05707520
Long-term Benefit of MPA in Liver Transplantation
An observational study of Liver Transplant Rejection and Immunosuppressant Adverse Reaction, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplant Rejection, Immunosuppressant Adverse Reaction
- What is being tested?
- enteric-coated mycophenolate (MPAs) and None MPA
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2022to 30 Sep 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Long-term survived liver transplant recipients in 13 hospitals in China
Who may be able to join
- Patients who underwent their first liver transplantation between January 1, 2016 and February 28, 2021;
- Recipient's survival time≥ 1 year;
- Age 18~65 years old;
- Patients with complete data and no loss to follow-up.
Who cannot join
- use of other types of anti-metabolic immunosuppressants;
- Second liver transplantation for various reasons within 1 year after the first transplantation;
- Patients with serious underlying diseases, including heart disease, infection and renal insufficiency, combined with other malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Yang Yang, PHD, yysysu@163.com
Yingcai Zhang, 76207884@qq.com
About this study
Official title: Clinical Evaluation of the Long-term Benefit of Enteric-coated Mycophenolate (MPAs) After Liver Transplantation
MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients.
- Being tested
- enteric-coated mycophenolate (MPAs), None MPA
- Keywords
- enteric-coated mycophenolate, adverse reaction, liver transplantation, transplant rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteric-coated mycophenolate (MPAs)Drug
Immunosuppression protocol with enteric-coated mycophenolate sodium
None MPADrug
Immunosuppression protocol without enteric-coated mycophenolate sodium
| Study group | Role | What they receive |
|---|---|---|
| MPA | Immunosuppressant with enteric-coated mycophenolate sodium Receives: Drug: enteric-coated mycophenolate (MPAs) | |
| None MPA | Immunosuppressant without enteric-coated mycophenolate sodium Receives: Drug: None MPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
complex endpoint
Graft loss or reoccurrence of HCC, or neoplasm, or death
Measured: 60 months after liver transplantation
Secondary outcomes (3)
Late onset acute rejection
rejection diagnosed by liver test, pathologic diagnosis by biopsy
Measured: 60 months after liver transplantation
Incidence of AKI or CKD
AKI/CKD diagnosed according to KDIGO 2012 AKI and CKD diagnosis criteria
Measured: 60 months after liver transplantation
Adverse events
Incidence of leukopenia/neutropenia, incidence of viral infections, incidence of new tumors (non-liver cancer).
Measured: 60 months after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start4 Dec 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RejectionStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, RenJi Hospital, The First Affiliated Hospital of Zhengzhou University, Beijing YouAn Hospital, Huashan Hospital, The Third Xiangya Hospital of Central South University, West China Hospital, Hebei Medical University Third Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Beijing Friendship Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Principal investigator, Yang Yang, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707520
- Sponsor's protocol ID
- [2022]02-146-01
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data will be shared on ResMan, after completion and the consent from investigators and IRB
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Long-term Benefit of Enteric-coated Mycophenolate (MPAs) After Liver Transplantation
- ClinicalTrials.gov ID
- NCT05707520
- Acronym / sponsor ID
- [2022]02-146-01
- Keywords
- enteric-coated mycophenolate, adverse reaction, liver transplantation, transplant rejection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Shulan (Hangzhou) Hospital, RenJi Hospital, The First Affiliated Hospital of Zhengzhou University, Beijing YouAn Hospital, Huashan Hospital, The Third Xiangya Hospital of Central South University, West China Hospital, Hebei Medical University Third Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Beijing Friendship Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 1 Feb 2023 (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.
MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems. Intestinal solvent-based MPA drugs are widely used in clinical practice by improving the dosage form, reducing the irritation of MPA to the mucosa of the digestive tract, improving the tolerability of patients and maintaining a sufficient amount of MPA. However, data on the use/long-term use of intestinal solvent-based MPAs in liver transplant recipients are lacking. The study aims to evaluate the long-term benefits of enteric-coated mycophenolic acid in liver transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPA | – | Drug: enteric-coated mycophenolate (MPAs)Immunosuppressant with enteric-coated mycophenolate sodium |
| None MPA | – | Drug: None MPAImmunosuppressant without enteric-coated mycophenolate sodium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Long-term survived liver transplant recipients in 13 hospitals in China
Key inclusion criteria (4 listed)
- Patients who underwent their first liver transplantation between January 1, 2016 and February 28, 2021;
- Recipient's survival time≥ 1 year;
- Age 18~65 years old;
- Patients with complete data and no loss to follow-up.
Key exclusion criteria (3 listed)
- use of other types of anti-metabolic immunosuppressants;
- Second liver transplantation for various reasons within 1 year after the first transplantation;
- Patients with serious underlying diseases, including heart disease, infection and renal insufficiency, combined with other malignant tumors.
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 |
|---|---|---|
| enteric-coated mycophenolate (MPAs)Immunosuppression protocol with enteric-coated mycophenolate sodium | Drug | MPA |
| None MPAImmunosuppression protocol without enteric-coated mycophenolate sodium | Drug | None MPA |
Primary outcome
complex endpoint
Time frame: 60 months after liver transplantation
Graft loss or reoccurrence of HCC, or neoplasm, or death
3 secondary outcomes
Late onset acute rejection
Time frame: 60 months after liver transplantation
Incidence of AKI or CKD
Time frame: 60 months after liver transplantation
Adverse events
Time frame: 60 months after liver transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: Undecided. individual participant data will be shared on ResMan, after completion and the consent from investigators and IRB
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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.
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 and Immunosuppressant Adverse Reaction, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 inclusion and 3 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 1 Feb 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yang, PhD (+8618922102666, yysysu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complex endpoint (time frame: 60 months after liver transplantation). 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 1 Feb 2023.