Liver TransplantationPhase 3NCT00459719
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation
A Phase 3 study testing Tacrolimus modified-release and Prograf in people with Liver Transplantation, run by Astellas Pharma Inc at 5 sites in China.
Trial summary
The patients about to undergo liver transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Tacrolimus modified-release and Prograf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesChina
- Study dates
- Mar 2007to Mar 2009
- Phase
- Phase 3
- 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
- Written informed consent with the date of the patient must be obtained.
- Patient between 18-70 years of age receiving the primary liver.
- Female patients must have a negative pregnancy test prior to the enrolment.
- Female patients of child bearing potential must agree to practice effective birth control during the study
Who cannot join
- Liver re-transplantation patients or received an organ transplantation other than a liver.
- Living-related liver transplantation patient.
- Patient has received an AB0 incompatible donor liver.
- Patient who needs antibody induction therapy.
- Patient with sever infection requiring treatment.
- Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Study site
Beijing, Beijing Municipality
Study site
Guangzhou, Guangdong
Study site
Hangzhou, Zhejiang
Study site
Shanghai, Shanghai Municipality
Study site
Tianjin
About this study
Official title: A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.
The patients about to undergo liver transplantation will be randomized to one of the following two group:
Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks
- Conditions
- Liver Transplantation
- Being tested
- Tacrolimus modified-release, Prograf
- Keywords
- Liver Transplantation, Tacrolimus, Methylprednisolone, Prednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus modified-releaseDrug
Also called Advagraf, FK506MR, MR4
oral
PrografDrug
Also called tacrolimus, FK506
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In combination with steroids Receives: Drug: Tacrolimus modified-release |
| 2 | Active comparator | In combination with steroids Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of patients with acute rejections
Measured: 12 Weeks
Secondary outcomes (3)
Incidence of and time to acute rejections
Measured: 12 Weeks
Overall frequency of acute rejections
Measured: 12 Weeks
Rate of patient and graft survival following transplantation.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Leng Xisheng, Principal investigator, Department of Hepatobiliary surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459719
- Sponsor's protocol ID
- MR4LTxCN01
- Status last verified
- Feb 2016
- First submitted
- 10 Apr 2007
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.
- ClinicalTrials.gov ID
- NCT00459719
- Acronym / sponsor ID
- MR4LTxCN01
- Conditions
- Liver Transplantation
- Keywords
- Liver Transplantation, Tacrolimus, Methylprednisolone, Prednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Apr 2007 (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 patients about to undergo liver transplantation will be randomized to one of the following two group:
Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tacrolimus modified-releaseIn combination with steroids |
| 2 | Active comparator | Drug: PrografIn combination with steroids |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent with the date of the patient must be obtained.
- Patient between 18-70 years of age receiving the primary liver.
- Female patients must have a negative pregnancy test prior to the enrolment.
- Female patients of child bearing potential must agree to practice effective birth control during the study
Key exclusion criteria (6 listed)
- Liver re-transplantation patients or received an organ transplantation other than a liver.
- Living-related liver transplantation patient.
- Patient has received an AB0 incompatible donor liver.
- Patient who needs antibody induction therapy.
- Patient with sever infection requiring treatment.
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 modified-releaseAlso: Advagraf, FK506MR, MR4oral | Drug | 1 |
| PrografAlso: tacrolimus, FK506oral | Drug | 2 |
Primary outcome
Event rate of patients with acute rejections
Time frame: 12 Weeks
3 secondary outcomes
Incidence of and time to acute rejections
Time frame: 12 Weeks
Overall frequency of acute rejections
Time frame: 12 Weeks
Rate of patient and graft survival following transplantation.
Time frame: 12 weeks
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 24 Feb 2016.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Prof. Leng Xisheng principal investigator
Department of Hepatobiliary surgery
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus modified-release and Prograf in people with Liver Transplantation, run by Astellas Pharma Inc at 5 sites 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 6 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Event rate of patients with acute rejections (time frame: 12 Weeks). 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 24 Feb 2016.