Liver TransplantNCT06183892
Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
A study testing Tacrolimus Sustained-release Capsules in people with Liver Transplant, run by RenJi Hospital at 1 site in China.
Trial summary
This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Tacrolimus Sustained-release Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
- Able to completely swallow capsules;
- Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
- Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
- Undergo a programmed liver biopsy;
Who cannot join
- Multi-organ combined transplantation or multiple liver transplantation;
- Adjuvant liver transplantation or use of bioartificial liver therapy;
- ABO incompatible children with liver transplantation;
- Allergic to tacrolimus;
- Participation in any other clinical study within 3 months prior to enrollment;
- Use of tacrolimus sustained release capsules before enrollment;
- Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai
Hao Feng, +8615000901110, surgeonfeng@live.com
About this study
This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
Read the detailed description
Tacrolimus is a commonly used immunosuppressant after liver transplantation. However, with increased postoperative time and a decline in postoperative compliance, some children may miss medication, leading to acute rejection. Repeated rejection can cause fibrosis of the transplanted liver, seriously impacting graft function and even postoperative survival, sometimes resulting in the need for a second liver transplant. In adult liver transplant recipients, tacrolimus sustained-release capsules have been shown to significantly improve overall and transplanted liver survival compared to conventional formulations (immediate-release tacrolimus，taken twice daily). Therefore, this study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
- Conditions
- Liver Transplant
- Being tested
- Tacrolimus Sustained-release Capsules
- Keywords
- liver transplant; pediatric liver transplant; tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus Sustained-release CapsulesDrug
Immediate-release tacrolimus for at least 3 months after liver transplantation, and then convert to tacrolimus sustained-release capsules at a ratio of 1:1 to 1:1.2; Take the medicine once a day on an empty stomach in the morning.
(The specific medication plan is decided by the clinician according to the actual situation)
| Study group | Role | What they receive |
|---|---|---|
| Prolonged-release tacrolimus | Experimental | Not described Receives: Drug: Tacrolimus Sustained-release Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy-confirmed acute rejection (BPAR)
biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification
Measured: 12 months
Incidence of allograft liver fibrosis
allograft liver fibrosis would be evaluated by LAFSc
Measured: 12 months
Secondary outcomes (5)
Liver function
alanine transaminase (ALT) and aspartate transaminase (AST), serum bilirubin, prothrombin time (PT), and albumin within and 12 months after conversion
Measured: 12 months
Kidney function
creatinine (Cr) and BUN within and 12 months after conversion
Measured: 12 months
Liver allograft survival rate
Liver allograft survival rate at 12 months after conversion
Measured: 12 months
The rate of drug change
The rate of drug change caused by ultrasonic diagnosis and abnormal liver function index suspected AR (from tacrolimus sustained release to other CNI drugs)
Measured: 12 months
Incidence of infection
Incidence of infection (viral, bacterial and fungal) at 12 months after conversion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start4 Mar 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiang Xia, Prof. MD, Study chair, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTUHao Feng, MD., Ph.D, Principal investigator, Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183892
- Sponsor's protocol ID
- Renji-LY2023-076-B
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT06183892
- Acronym / sponsor ID
- Renji-LY2023-076-B
- Conditions
- Liver Transplant
- Keywords
- liver transplant; pediatric liver transplant; tacrolimus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 28 Dec 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.
This study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
Detailed description
Tacrolimus is a commonly used immunosuppressant after liver transplantation. However, with increased postoperative time and a decline in postoperative compliance, some children may miss medication, leading to acute rejection. Repeated rejection can cause fibrosis of the transplanted liver, seriously impacting graft function and even postoperative survival, sometimes resulting in the need for a second liver transplant. In adult liver transplant recipients, tacrolimus sustained-release capsules have been shown to significantly improve overall and transplanted liver survival compared to conventional formulations (immediate-release tacrolimus，taken twice daily). Therefore, this study aims to explore the effects of tacrolimus sustained-release capsules on the incidence of biopsy-proven acute rejection(BPAR) and fibrosis in pediatric liver transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged-release tacrolimus | Experimental | Drug: Tacrolimus Sustained-release Capsules |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
- Able to completely swallow capsules;
- Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
- Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
- Undergo a programmed liver biopsy;
Key exclusion criteria (7 listed)
- Multi-organ combined transplantation or multiple liver transplantation;
- Adjuvant liver transplantation or use of bioartificial liver therapy;
- ABO incompatible children with liver transplantation;
- Allergic to tacrolimus;
- Participation in any other clinical study within 3 months prior to enrollment;
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 Sustained-release CapsulesImmediate-release tacrolimus for at least 3 months after liver transplantation, and then convert to tacrolimus sustained-release capsules at a ratio of 1:1 to 1:1.2; Take the medicine once a day on an empty stomach in the morning. (The specific medication plan is decided by the clinician according to the actual situation) | Drug | Prolonged-release tacrolimus |
Primary outcome
Incidence of biopsy-confirmed acute rejection (BPAR)
Time frame: 12 months
biopsy-confirmed acute rejection (BPAR) would be evaluated by the international Banff classification
Incidence of allograft liver fibrosis
Time frame: 12 months
allograft liver fibrosis would be evaluated by LAFSc
5 secondary outcomes
Liver function
Time frame: 12 months
Kidney function
Time frame: 12 months
Liver allograft survival rate
Time frame: 12 months
The rate of drug change
Time frame: 12 months
Incidence of infection
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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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.
Qiang Xia, Prof. MD study chair
Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
Hao Feng, MD., Ph.D principal investigator
Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus Sustained-release Capsules in people with Liver Transplant, run by RenJi Hospital 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Feng, MD., Ph.D (008615000901110, surgeonfeng@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of biopsy-confirmed acute rejection (BPAR) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 18 Dec 2024.