de Novo Liver Transplant SubjectsPhase 4MapleNCT01882322
A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects
A Phase 4 study testing Prograf and Advagraf in people with de Novo Liver Transplant Subjects, run by Astellas Pharma Korea, Inc. at 1 site in South Korea.
Trial summary
The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- de Novo Liver Transplant Subjects
- What is being tested?
- Prograf and Advagraf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2013to 3 Jan 2017
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject scheduled for liver transplantation from a living donor or brain dead
- In case of a woman of childbearing potential, a subject with a negative pregnancy test prior to enrollment and who consents to and would practice double contraception throughout the study (Pessary therapy, or rhythm method, or sexual abstinence, surgical sterilization, menopause or otherwise sterile; however, oral contraceptives are excluded.)
- A subject with terminal hepatic failure for which liver transplant is necessary
- A subject who understands and is completely aware of the study objective and risks and who submitted a written informed consent form on study participation
Who cannot join
- A subject who received multiple organ transplants or any previous organ transplant (including re-transplantation of the liver)
- A subject who had received auxiliary transplant or used the bioartificial liver (cellular system)
- A subject allergic or resistant to macrolide antibiotics or Tacrolimus
- A subject who was taking Cyclosporine and Bosentan (Tracleer) that may interact with Tacrolimus, or potassium-sparing diuretics known to possibly cause hyperkalemia (Spironolactone, Triamterene) at screening
- A subject who requires immunosuppressive treatment or systemic chemotherapy from before transplant. However, a subject who received immunosuppressive treatment for less than 1 month prior to transplant to treat underlying hepatic disorder may be enrolled in the study if treatment is discontinued at the time of transplant.
- A subject with malignancy or malignant tumor history within the past 5 years; however, a subject may be enrolled in this study in case of successfully cured for basal cell carcinoma or squamous cell carcinoma of the skin.
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- A subject who suffers severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect Tacrolimus absorption (may be determined at the discretion of the investigator)
- A subject with any type of substance abuse, psychological disorder, or communication disorder at the discretion of the investigator
- A subject who is participating in another study or participated within 28 days of the study, or who had received IP or non-registered medication
- A subject who is pregnant or breastfeeding
- A subject (transplant recipient) and/or donor who are positive to HIV
- A subject who cannot comply with the protocol-planned routine visit schedule
- A subject who is not appropriate for study participation at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Advagraf® (Modified Release Tacrolimus, Once Daily) After Using Prograf® (Tacrolimus Twice Daily) in de Novo Liver Transplant Recipients
The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.
Read the detailed description
De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while Prograf therapy will be continued in other group.
- Conditions
- de Novo Liver Transplant Subjects
- Being tested
- Prograf, Advagraf
- Keywords
- FK506, tacrolimus, immunosuppressant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrografDrug
Also called Tacrolimus
oral
AdvagrafDrug
Also called modified release Tacrolimus
oral
| Study group | Role | What they receive |
|---|---|---|
| Advagraf conversion group | Experimental | Oral Receives: Drug: Prograf; Drug: Advagraf |
| Prograf maintenance group | Active comparator | Oral Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy-confirmed acute rejection
Acute rejection incidence (%) = Number of subjects with at least one biopsy -confirmed acute rejection / Total number of subjects included in the relevant analysis set * 100
Measured: from Week 4 to Week 24 post-transplant
Secondary outcomes (4)
Incidence of biopsy-confirmed acute rejection
Measured: from Week 4 to Week 12 or Week 24
Severity of biopsy-confirmed acute rejection
Severity guideline is Banff criteria
Measured: from Week 4 to Week 12 and Week 24 after liver transplant
Subject survival rate and graft survival rate
Measured: from Week 4 to Week 12 and Week 24 after liver transplant
Safety assessed by the incidence of adverse events, vital signs, physical exam. and labo-tests
Measured: for 24 weeks after liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study start30 Jan 2013
- Primary completion3 Jan 2017
- Study completion3 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for de Novo Liver Transplant SubjectsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Korea, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882322
- Sponsor's protocol ID
- ADV-LT-01
- Acronym
- Maple
- Status last verified
- Oct 2024
- First submitted
- 18 Jun 2013
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Advagraf® (Modified Release Tacrolimus, Once Daily) After Using Prograf® (Tacrolimus Twice Daily) in de Novo Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01882322
- Acronym / sponsor ID
- Maple / ADV-LT-01
- Conditions
- de Novo Liver Transplant Subjects
- Keywords
- FK506, tacrolimus, immunosuppressant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2013 (actual)
- Primary completion
- 3 Jan 2017 (actual)
- Study completion
- 3 Jan 2017 (actual)
- First posted
- 20 Jun 2013 (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.
The objective of this study is to compare the efficacy and safety between a group that has been on Prograf twice daily therapy but converted to Advagraf once daily therapy and a group that maintained Prograf twice daily therapy.
Detailed description
De novo Liver Transplant Recipients will be divided into two groups. Both groups will receive Prograf (Tacrolimus twice daily therapy), and at Month 1 (Week 4) after surgery, Prograf will be converted to Advagraf (modified release Tacrolimus, once daily) in one group, while Prograf therapy will be continued in other group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advagraf conversion group | Experimental | Drug: Prograf, Drug: AdvagrafOral |
| Prograf maintenance group | Active comparator | Drug: PrografOral |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A subject scheduled for liver transplantation from a living donor or brain dead
- In case of a woman of childbearing potential, a subject with a negative pregnancy test prior to enrollment and who consents to and would practice double contraception throughout the study (Pessary therapy, or rhythm method, or sexual abstinence, surgical sterilization, menopause or otherwise sterile; however, oral contraceptives are excluded.)
- A subject with terminal hepatic failure for which liver transplant is necessary
- A subject who understands and is completely aware of the study objective and risks and who submitted a written informed consent form on study participation
Key exclusion criteria (13 listed)
- A subject who received multiple organ transplants or any previous organ transplant (including re-transplantation of the liver)
- A subject who had received auxiliary transplant or used the bioartificial liver (cellular system)
- A subject allergic or resistant to macrolide antibiotics or Tacrolimus
- A subject who was taking Cyclosporine and Bosentan (Tracleer) that may interact with Tacrolimus, or potassium-sparing diuretics known to possibly cause hyperkalemia (Spironolactone, Triamterene) at screening
- A subject who requires immunosuppressive treatment or systemic chemotherapy from before transplant. However, a subject who received immunosuppressive treatment for less than 1 month prior to transplant to treat underlying hepatic disorder may be enrolled in the study if treatment is discontinued at the time of transplant.
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 |
|---|---|---|
| PrografAlso: Tacrolimusoral | Drug | Advagraf conversion group, Prograf maintenance group |
| AdvagrafAlso: modified release Tacrolimusoral | Drug | Advagraf conversion group |
Primary outcome
Incidence of biopsy-confirmed acute rejection
Time frame: from Week 4 to Week 24 post-transplant
Acute rejection incidence (%) = Number of subjects with at least one biopsy -confirmed acute rejection / Total number of subjects included in the relevant analysis set * 100
4 secondary outcomes
Incidence of biopsy-confirmed acute rejection
Time frame: from Week 4 to Week 12 or Week 24
Severity of biopsy-confirmed acute rejection
Time frame: from Week 4 to Week 12 and Week 24 after liver transplant
Subject survival rate and graft survival rate
Time frame: from Week 4 to Week 12 and Week 24 after liver transplant
Safety assessed by the incidence of adverse events, vital signs, physical exam. and labo-tests
Time frame: for 24 weeks after liver transplant
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 31 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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.
Medical Director study director
Astellas Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prograf and Advagraf in people with de Novo Liver Transplant Subjects, run by Astellas Pharma Korea, Inc. 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 4 inclusion and 13 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 31 Oct 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 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.
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?
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 biopsy-confirmed acute rejection (time frame: from Week 4 to Week 24 post-transplant). 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 31 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.