Liver TransplantationPhase 3NCT00719745
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients
A Phase 3 study testing Prograf and MR4 in people with Liver Transplantation, run by Astellas Pharma Inc at 1 site in South Korea.
Trial summary
To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation. 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?
- Prograf and MR4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2006to Jun 2008
- 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
- Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
- Patients who need liver transplantation due to the end-stage liver failure
Who cannot join
- Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
- Patients receiving auxiliary graft or in whom a bio-artificial
- Patients allergic to macrolide antibiotics or tacrolimus
- Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed
- Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
- Patients with systemic infection requiring treatment, except viral hepatitis
Show all 13Show fewer
- Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- Patients with serum creatinine > 1.5mg/Dl
- Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator
- Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days
- Patients who are pregnant or breast-feeding mother
- Patients or donors known to be HIV positive
- Patients unlikely to comply with the visits scheduled in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Liver Transplant Recipients
To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.
- Conditions
- Liver Transplantation
- Being tested
- Prograf, MR4
- Keywords
- Organ transplantation, Tacrolimus, Prograf, MR4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrografDrug
Also called Tacrolimus, FK506
oral
MR4Drug
Also called Modified Release Tacrolimus, FK506MR, FK506E
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Prograf |
| 2 | Experimental | Not described Receives: Drug: MR4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event rate of patients with biopsy-proven acute rejections
Measured: 24 weeks
Secondary outcomes (4)
Incidence of and time to acute rejections and corticosteroid resistant acute rejections
Measured: 12 and 24 weeks
Severity of biopsy-proven acute rejections.
Measured: 24 weeks
Patient and graft survival
Measured: 12 and 24 weeks
Incidence of adverse events
Measured: Throughout trial
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 startFeb 2006
- Primary completionJun 2008
- Study completionJun 2008
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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Investigators
- Central Contact, Study chair, Astellas Pharma Korea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719745
- Sponsor's protocol ID
- MR-05-02-KOR
- Status last verified
- Jul 2008
- First submitted
- 18 Jul 2008
- Last updated
- 22 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT00719745
- Acronym / sponsor ID
- MR-05-02-KOR
- Conditions
- Liver Transplantation
- Keywords
- Organ transplantation, Tacrolimus, Prograf, MR4
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Feb 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (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.
To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Prograf |
| 2 | Experimental | Drug: MR4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
- Patients who need liver transplantation due to the end-stage liver failure
Key exclusion criteria (13 listed)
- Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
- Patients receiving auxiliary graft or in whom a bio-artificial
- Patients allergic to macrolide antibiotics or tacrolimus
- Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed
- Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
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: Tacrolimus, FK506oral | Drug | 1 |
| MR4Also: Modified Release Tacrolimus, FK506MR, FK506Eoral | Drug | 2 |
Primary outcome
Event rate of patients with biopsy-proven acute rejections
Time frame: 24 weeks
4 secondary outcomes
Incidence of and time to acute rejections and corticosteroid resistant acute rejections
Time frame: 12 and 24 weeks
Severity of biopsy-proven acute rejections.
Time frame: 24 weeks
Patient and graft survival
Time frame: 12 and 24 weeks
Incidence of adverse events
Time frame: Throughout trial
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 22 Jul 2008.
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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 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 Prograf and MR4 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 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 22 Jul 2008. 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?
Event rate of patients with biopsy-proven acute rejections (time frame: 24 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 22 Jul 2008.