Liver TransplantationPhase 3NCT00189826
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.
A Phase 3 study testing tacrolimus in people with Liver Transplantation, run by Astellas Pharma Inc at 51 sites in 16 countries.
Trial summary
To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids 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?
- tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 475 participants
- Where
- 51 sitesin 16 countries
- Study dates
- Aug 2004to Dec 2006
- 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, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.
Who cannot join
- Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).
- Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
- Patients with serum creatinine > 200 µmol/l..
Trial locations and contacts
51 sites in 16 countries.
51 sites in 16 countries
France8 sites
Study site
Clichy
Study site
Créteil
Study site
Lyon
Study site
Montpellier
Study site
Rennes
Study site
Strasbourg
Study site
Toulouse
Study site
Villejuif
Spain7 sites
Study site
Barakaldo
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Córdoba
Study site
Santiago de Compostela
Study site
Seville
Study site
Valencia
Italy6 sites
Study site
Bergamo
Study site
Bologna
Study site
Genova
Study site
Modena
Study site
Palermo
Study site
Udine
Canada5 sites
Study site
Edmonton, Alberta
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Brazil4 sites
Study site
Bel Horizonte, 30130
Study site
Porto Alegre
Study site
Rio de Janeiro, 21041
Study site
São Paulo, 01431
Germany4 sites
Study site
Berlin
Study site
Hamburg
Study site
Heidelberg
Study site
Regensburg
United Kingdom4 sites
Study site
Leeds
Study site
London, NW3 2QG
Study site
London, SE5 9 RS
Study site
Newcastle upon Tyne
About this study
Official title: A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation
To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.
Read the detailed description
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.
- Conditions
- Liver Transplantation
- Being tested
- tacrolimus
- Keywords
- Tacrolimus, Liver transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called FK506E, MR4
immunosuppression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: tacrolimus |
| 2 | Experimental | Not described Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of and time to biopsy-proven acute rejections
Measured: 12 months
Secondary outcomes (1)
Incidence of acute rejections
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- J. Langrehr, Principal investigator, Charite Campus Virchow Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189826
- Sponsor's protocol ID
- FG-506E-11-03
- Status last verified
- Jul 2014
- First submitted
- 13 Sep 2005
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ericzon BG, Varo E, Trunecka P, Fischer L, Colledan M, Gridelli B, Valdivieso A, O'Grady J, Dickinson J, Undre N. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12958. Epub 2017 Apr 27.
PubMed 28295581
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double Blind, Two Arm Parallel Group Study to Evaluate and Compare the Efficacy and Safety of Modified Release Tacrolimus FK506E (MR4) Versus Tacrolimus FK506 in Combination With Steroids in Patients Undergoing Primary Liver Transplantation
- ClinicalTrials.gov ID
- NCT00189826
- Acronym / sponsor ID
- FG-506E-11-03
- Conditions
- Liver Transplantation
- Keywords
- Tacrolimus, Liver transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Sep 2005 (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 a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.
Detailed description
A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: tacrolimus |
| 2 | Experimental | Drug: tacrolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.
Key exclusion criteria (3 listed)
- Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).
- Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
- Patients with serum creatinine > 200 µmol/l..
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 |
|---|---|---|
| tacrolimusAlso: FK506E, MR4immunosuppression | Drug | 1, 2 |
Primary outcome
Incidence of and time to biopsy-proven acute rejections
Time frame: 12 months
1 secondary outcome
Incidence of acute rejections
Time frame: 12 months
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 9 Jul 2014.
- Derived from this study: PubMed 28295581Ericzon BG, Varo E, Trunecka P, Fischer L, Colledan M, Gridelli B, Valdivieso A, O'Grady J, Dickinson J, Undre N. Pharmacokinetics of prolonged-release tacrolimus versus immediate-release tacrolimus in de novo liver transplantation: A randomized phase III substudy. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12958. Epub 2017 Apr 27.
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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.
J. Langrehr principal investigator
Charite Campus Virchow Klinikum
51 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus in people with Liver Transplantation, run by Astellas Pharma Inc at 51 sites in 16 countries.
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 1 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 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in France, Spain, Italy, Canada, Brazil and 11 more countries. 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 and time to biopsy-proven acute rejections (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00189826, which also lists 1 linked publication.
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 9 Jul 2014.