Liver TransplantationPhase 3NCT00909571
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
A Phase 3 study testing FK506E (modified release tacrolimus) and Prograf (tacrolimus) in people with Liver Transplantation, run by Astellas Pharma Inc at 1 site in South Korea.
Trial summary
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens. 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?
- FK506E (modified release tacrolimus) and Prograf (tacrolimus)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2009to Mar 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving a primary partial liver graft from a living donor
- Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study
Who cannot join
- Patients receiving a multi-organ transplantation or having previously received an organ transplantation
- Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
- Patients allergic or intolerant to macrolide antibodies or Tacrolimus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3 Pilot Study to Describe the Pharmacokinetics of Tacrolimus in Patients Undergoing Primary Liver Donor Liver Transplantation Treated With Prograf Injection and Modified Release Tacrolimus Based Immunosuppressive Regimen
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
Read the detailed description
To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.
- Conditions
- Liver Transplantation
- Being tested
- FK506E (modified release tacrolimus), Prograf (tacrolimus)
- Keywords
- FK506E, MR4, Prograf, Tacrolimus, Living Liver Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK506E (modified release tacrolimus)Drug
Also called MR4, modified release Tacrolimus
oral
Prograf (tacrolimus)Drug
Also called FK506, tacrolimus
injection
| Study group | Role | What they receive |
|---|---|---|
| 1. FK506E high dose group | Experimental | Not described Receives: Drug: FK506E (modified release tacrolimus); Drug: Prograf (tacrolimus) |
| 2. FK506E low dose group | Experimental | Not described Receives: Drug: FK506E (modified release tacrolimus); Drug: Prograf (tacrolimus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pharmacokinetic parameters
Measured: Day 6 and Day 14
Secondary outcomes (3)
Incidence of acute rejection
Measured: within 12 weeks
Time to acute rejection
Measured: within 12 weeks
Assessment of graft survival
Measured: within 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2010
- Study completionMar 2010
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909571
- Sponsor's protocol ID
- MR-08-04-KOR
- Status last verified
- Apr 2010
- First submitted
- 27 May 2009
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Pilot Study to Describe the Pharmacokinetics of Tacrolimus in Patients Undergoing Primary Liver Donor Liver Transplantation Treated With Prograf Injection and Modified Release Tacrolimus Based Immunosuppressive Regimen
- ClinicalTrials.gov ID
- NCT00909571
- Acronym / sponsor ID
- MR-08-04-KOR
- Conditions
- Liver Transplantation
- Keywords
- FK506E, MR4, Prograf, Tacrolimus, Living Liver Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Apr 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 May 2009 (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.
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
Detailed description
To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. FK506E high dose group | Experimental | Drug: FK506E (modified release tacrolimus), Drug: Prograf (tacrolimus) |
| 2. FK506E low dose group | Experimental | Drug: FK506E (modified release tacrolimus), Drug: Prograf (tacrolimus) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving a primary partial liver graft from a living donor
- Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study
Key exclusion criteria (3 listed)
- Patients receiving a multi-organ transplantation or having previously received an organ transplantation
- Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
- Patients allergic or intolerant to macrolide antibodies or Tacrolimus
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 |
|---|---|---|
| FK506E (modified release tacrolimus)Also: MR4, modified release Tacrolimusoral | Drug | 1. FK506E high dose group, 2. FK506E low dose group |
| Prograf (tacrolimus)Also: FK506, tacrolimusinjection | Drug | 1. FK506E high dose group, 2. FK506E low dose group |
Primary outcome
Assessment of pharmacokinetic parameters
Time frame: Day 6 and Day 14
3 secondary outcomes
Incidence of acute rejection
Time frame: within 12 weeks
Time to acute rejection
Time frame: within 12 weeks
Assessment of graft survival
Time frame: within 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 16 Apr 2010.
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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.
Use Central Contact study chair
Astellas Pharma Korea, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FK506E (modified release tacrolimus) and Prograf (tacrolimus) in people with Liver Transplantation, run by Astellas Pharma 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 2 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: finished, as of the sponsor's last update on 16 Apr 2010. 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 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?
Assessment of pharmacokinetic parameters (time frame: Day 6 and Day 14). 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 16 Apr 2010.