Liver TransplantationPhase 3NCT00619398
A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
A Phase 3 study testing Prograf and FK506MR capsule in people with Liver Transplantation, run by Astellas Pharma Inc at 6 sites in China.
Trial summary
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety. 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?
- Prograf and FK506MR capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 6 sitesChina
- Study dates
- Jan 2008to 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 is the recipient of a liver transplant from 6 to 24 months prior to enrollment
- Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy
- At screening the liver and kidney function of patient is stable (defined as Serum creatinine is normal and ALT or AST is <= 2 times the upper value of normal range)
- Patient has the stable whole blood trough level concentration of Prograf (defined as tacrolimus trough concentrations of 2-10ng/ml measured 14 days prior to enrollment), and is clinically stable in the opinion of the investigator
Who cannot join
- Patient has received an organ transplant other than a kidney
- Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy
- Patient is currently receiving other immunosuppressant therapy, eg. sirolimus
- Patient with liver recurrent cancer, or metastasis, or other cancer
- Patient has any unstable medical condition that could interfere with the study objectives
- Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment
Show all 9Show fewer
- Patient is allergic macrolide antibiotics or tacrolimus
- Patient has psychiatric disorder, in the opinion of the investigator, may invalidate communication with the investigator
- Patient is currently receiving any medications, which is know to alter the CYP450 3A enzyme system (including grapefruit juice)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Study site
Beijing, Beijing Municipality
Study site
Guangzhou, Guangdong
Study site
Hangzhou, Zhejiang
Study site
Shanghai, Shanghai Municipality
Study site
Shenyang, Liaoning
Study site
Tianjing
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 Stable Liver Transplantation Patients and a Pharmacokinetics Study
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.
Read the detailed description
A multicentre, randomized, open label, two parallel group study The patients will be randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12 weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.
- Conditions
- Liver Transplantation
- Being tested
- Prograf, FK506MR capsule
- Keywords
- FK506, tacrolimus, prograf, Liver transplantation
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
FK506MR capsuleDrug
Also called Advagraf, tacrolimus modified release capsule, MR4, Prograf XL
Oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Prograf |
| 2 | Experimental | Not described Receives: Drug: FK506MR capsule |
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 (4)
Incidence of and time to acute rejections
Measured: 12 Weeks
Overall frequency of acute rejections
Measured: 12 Weeks
Rate of patients and graft survival following transplantation
Measured: 12 Weeks
Incidence of adverse events including laboratory assessments
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 posted21 Feb 2008 (estimated)
- Study startJan 2008
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619398
- Sponsor's protocol ID
- MR4LTxCN02
- Status last verified
- Feb 2016
- First submitted
- 23 Jan 2008
- 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 Stable Liver Transplantation Patients and a Pharmacokinetics Study
- ClinicalTrials.gov ID
- NCT00619398
- Acronym / sponsor ID
- MR4LTxCN02
- Conditions
- Liver Transplantation
- Keywords
- FK506, tacrolimus, prograf, Liver transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Feb 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.
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.
Detailed description
A multicentre, randomized, open label, two parallel group study The patients will be randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12 weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.
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: FK506MR capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent with the date of the patient must be obtained
- Patient is the recipient of a liver transplant from 6 to 24 months prior to enrollment
- Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy
- At screening the liver and kidney function of patient is stable (defined as Serum creatinine is normal and ALT or AST is <= 2 times the upper value of normal range)
- Patient has the stable whole blood trough level concentration of Prograf (defined as tacrolimus trough concentrations of 2-10ng/ml measured 14 days prior to enrollment), and is clinically stable in the opinion of the investigator
Key exclusion criteria (9 listed)
- Patient has received an organ transplant other than a kidney
- Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy
- Patient is currently receiving other immunosuppressant therapy, eg. sirolimus
- Patient with liver recurrent cancer, or metastasis, or other cancer
- Patient has any unstable medical condition that could interfere with the study objectives
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 |
| FK506MR capsuleAlso: Advagraf, tacrolimus modified release capsule, MR4, Prograf XLOral | Drug | 2 |
Primary outcome
Event rate of patients with acute rejections
Time frame: 12 Weeks
4 secondary outcomes
Incidence of and time to acute rejections
Time frame: 12 Weeks
Overall frequency of acute rejections
Time frame: 12 Weeks
Rate of patients and graft survival following transplantation
Time frame: 12 Weeks
Incidence of adverse events including laboratory assessments
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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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
6 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 and FK506MR capsule in people with Liver Transplantation, run by Astellas Pharma Inc at 6 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 5 inclusion and 9 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 6 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.