Liver TransplantationPhase 3NCT00720408
A Randomized Study to Assess the Safety and Efficacy of Prograf vs Prograf-XL in de Novo Liver Transplant Recipients.
A Phase 3 study testing Prograf-XL, Prograf and MMF in people with Liver Transplantation and Transplantation Immunology, run by Astellas Pharma Inc at 4 sites in Taiwan.
Trial summary
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation, Transplantation Immunology, Host vs Graft Reaction
- What is being tested?
- Prograf-XL, Prograf and MMF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesTaiwan
- Study dates
- Dec 2007to Sep 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
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- Patient is a primary liver transplant recipient
- Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
Who cannot join
- Patient has previously received or is receiving an organ transplant other than a liver
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- Patient has received a liver transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor liver
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully
- Patient has fulminant hepatic failure, unless hemodynamically stable
Show all 13Show fewer
- Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
- Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
- Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
- Patient is pregnant or lactating
- Patient is unlikely to comply with the visits scheduled in the protocol, including the protocol biopsies
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Study site
Kaohsiung City, 833
Study site
Taipei, 100
Study site
Taipei, 112
Study site
Taoyuan, 333
About this study
Official title: A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF and Steroid Withdraw in de Novo Liver Transplant Recipients.
The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients
- Being tested
- Prograf-XL, Prograf, MMF
- Keywords
- Immunosuppressant, Graft loss, Combination drug therapy, Randomized controlled trial, Open level method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prograf-XLDrug
Also called tacrolimus extended release, FK506E, MR4
oral
PrografDrug
Also called tacrolimus, FK506
oral
MMFDrug
Also called Mycophenolate Mofetil
oral
| Study group | Role | What they receive |
|---|---|---|
| Prograf-XL + MMF | Experimental | Not described Receives: Drug: Prograf-XL; Drug: MMF |
| Prograf + MMF | Active comparator | Not described Receives: Drug: Prograf; Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant.
Measured: 6 month
Secondary outcomes (3)
Patient and graft survival rates during the 6 and 12 months post-transplant
Measured: 6 and 12 month
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant
Measured: 12 month
Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant
Measured: 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2009
- Study completionSep 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720408
- Sponsor's protocol ID
- PRGXLLTx-0702-TW
- Status last verified
- Sep 2009
- First submitted
- 18 Jul 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF and Extended Release (XL) Tacrolimus /MMF and Steroid Withdraw in de Novo Liver Transplant Recipients.
- ClinicalTrials.gov ID
- NCT00720408
- Acronym / sponsor ID
- PRGXLLTx-0702-TW
- Keywords
- Immunosuppressant, Graft loss, Combination drug therapy, Randomized controlled trial, Open level method
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- Dec 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Jul 2008 (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 purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF and steroid withdrawal in de novo Liver transplant recipients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prograf-XL + MMF | Experimental | Drug: Prograf-XL, Drug: MMF |
| Prograf + MMF | Active comparator | Drug: Prograf, Drug: MMF |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
- Patient is a primary liver transplant recipient
- Patient must receive first dose of XL or Prograf (or IV tacrolimus for subjects unable to tolerate oral study drug) within 48 hours of transplantation
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
Key exclusion criteria (13 listed)
- Patient has previously received or is receiving an organ transplant other than a liver
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
- Patient has received a liver transplant from a non-heart beating donor
- Patient has received an ABO incompatible donor liver
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except hepatocellular carcinoma within UCSF Criteria 21 and basal or non-metastatic squamous cell carcinoma of skin that has been treated successfully
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 |
|---|---|---|
| Prograf-XLAlso: tacrolimus extended release, FK506E, MR4oral | Drug | Prograf-XL + MMF |
| PrografAlso: tacrolimus, FK506oral | Drug | Prograf + MMF |
| MMFAlso: Mycophenolate Mofetiloral | Drug | Prograf + MMF, Prograf-XL + MMF |
Primary outcome
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant.
Time frame: 6 month
3 secondary outcomes
Patient and graft survival rates during the 6 and 12 months post-transplant
Time frame: 6 and 12 month
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 12 months post-transplant
Time frame: 12 month
Incidence of anti-lymphocyte antibody therapy for treatment of rejection during the 6 and 12 months post-transplant
Time frame: 6 and 12 month
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 15 Sep 2009.
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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.
Central Contact study chair
Astellas Pharma Inc
4 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 Prograf-XL, Prograf and MMF in people with Liver Transplantation and Transplantation Immunology, run by Astellas Pharma Inc at 4 sites in Taiwan.
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 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
Incidence of biopsy confirmed acute rejection (local assessment of biopsies performed due to hepatic dysfunction) during the 6 months post-transplant. (time frame: 6 month). 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 15 Sep 2009.