Liver TransplantationPhase 4NCT06147648
Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation.
A Phase 4 study testing Tacrolimus Sustained-release Capsules in people with Liver Transplantation, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- 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
- 352 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Jul 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above
- 3 months after liver transplantation;
- Stable use of immediate-release tacrolimus for at least one month before enrollment in the study;
- The serum levels of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] were within the normal range; ….
Who cannot join
- Multi-organ combined transplantation or multiple liver transplantation;
- Multiple organ recipients or those who have previously transplanted any organs；
- Adjuvant liver transplantation or use of bioartificial liver therapy;
- Prior to joining the group, they had received treatment with immune checkpoint (ICIs);
- 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 5 ng/ml at the time of screening;
- Acute rejection occurred within one month prior to enrollment; ….
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Liver Transplant Recipients
Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Moreover, there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients. Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period. At the same time, patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery, and the proportion of drug conversion needs to be further explored.
This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation. Furthermore, it seeks to investigate the impact of this conversion on indicators such as liver function, kidney function, metabolic disease incidence, and infection incidence in patients.
- Conditions
- Liver Transplantation
- Being tested
- Tacrolimus Sustained-release Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus Sustained-release CapsulesDrug
Transition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Single arm observational registry study Drug: Tacrolimus Sustained-release Capsules | Experimental | Drug: Tacrolimus Sustained-release Capsules
After liver transplantation, immediate-release tacrolimus was administered for acute rejection prevention, and after 3 months, it was converted into tacrolimus sustained-release capsules in a ratio of 1:1 to 1:1.2; (The specific medication plan is decided by the clinician according to the actual situation) 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) within 3, 6, and 12 months after conversion
Measured: within 3, 6, and 12 months after conversion
Secondary outcomes (6)
Graft survival rate and patient survival rate at 12 months after conversion
Measured: 12 months after conversion
The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules;
Measured: 3 months after liver transplantation
Incidence of infection (viral, bacterial and fungal) at 12 months after conversion;
Measured: 12 months after conversion;
Observe the serum aspartate aminotransferase (AST) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Measured: within 3,6,12 months after conversion
Observe the serum alanine aminotransferase (ALT) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Measured: within 3,6,12 months after conversion
Observe the creatinine clearance rate of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Measured: within 3,6,12 months after conversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 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 TransplantationStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, QIAN LU, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147648
- Sponsor's protocol ID
- 23163-4-01
- Status last verified
- Nov 2023
- First submitted
- 12 Oct 2023
- Last updated
- 27 Nov 2023
- 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 27 Nov 2023. 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 Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT06147648
- Acronym / sponsor ID
- 23163-4-01
- Conditions
- Liver Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 27 Nov 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.
Tacrolimus is a commonly used immunosuppressant after liver transplantation. A once-daily administration of prolonged-release tacrolimus has been found to improve patient compliance and offer good efficacy and safety. Moreover, there is evidence that this prolonged-release formulation mitigates renal impairment and metabolic syndrome in transplant recipients. Foreign studies have confirmed that it is safe and feasible for liver transplant recipients to switch from immediate-release tacrolimus to prolonged-release tacrolimus during the stable period. At the same time, patients with early conversion are more likely to benefit in terms of graft survival and renal function recovery, and the proportion of drug conversion needs to be further explored.
This study aims to assess the efficacy and safety of switching from immediate-release tacrolimus to prolonged-release tacrolimus three months after liver transplantation. Furthermore, it seeks to investigate the impact of this conversion on indicators such as liver function, kidney function, metabolic disease incidence, and infection incidence in patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Single arm observational registry study Drug: Tacrolimus Sustained-release Capsules | Experimental | Drug: Tacrolimus Sustained-release CapsulesDrug: Tacrolimus Sustained-release Capsules After liver transplantation, immediate-release tacrolimus was administered for acute rejection prevention, and after 3 months, it was converted into tacrolimus sustained-release capsules in a ratio of 1:1 to 1:1.2; (The specific medication plan is decided by the clinician according to the actual situation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old and above
- 3 months after liver transplantation;
- Stable use of immediate-release tacrolimus for at least one month before enrollment in the study;
- The serum levels of aspartate aminotransferase [AST] and alanine aminotransferase [ALT] were within the normal range; ….
Key exclusion criteria (8 listed)
- Multi-organ combined transplantation or multiple liver transplantation;
- Multiple organ recipients or those who have previously transplanted any organs；
- Adjuvant liver transplantation or use of bioartificial liver therapy;
- Prior to joining the group, they had received treatment with immune checkpoint (ICIs);
- 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 CapsulesTransition from Immediate-release tacrolimus to prolonged-release tacrolimus at 3 months after liver transplantation | Drug | Experimental: Single arm observational registry study Drug: Tacrolimus Sustained-release Capsules |
Primary outcome
Incidence of biopsy-confirmed acute rejection (BPAR) within 3, 6, and 12 months after conversion
Time frame: within 3, 6, and 12 months after conversion
6 secondary outcomes
Graft survival rate and patient survival rate at 12 months after conversion
Time frame: 12 months after conversion
The conversion dose ratio from ordinary tacrolimus to tacrolimus sustained-release capsules;
Time frame: 3 months after liver transplantation
Incidence of infection (viral, bacterial and fungal) at 12 months after conversion;
Time frame: 12 months after conversion;
Observe the serum aspartate aminotransferase (AST) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Time frame: within 3,6,12 months after conversion
Observe the serum alanine aminotransferase (ALT) levels of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Time frame: within 3,6,12 months after conversion
Observe the creatinine clearance rate of subjects at 3, 6, and 12 months after switching to the prolonged-release tacrolimus.
Time frame: within 3,6,12 months after conversion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus Sustained-release Capsules in people with Liver Transplantation, run by Beijing Tsinghua Chang Gung Hospital.
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 8 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 27 Nov 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 XUAN TONG, Doctor (15901019879, txa00853@btch.edu.cn), 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) within 3, 6, and 12 months after conversion (time frame: within 3, 6, and 12 months after conversion). 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 27 Nov 2023.