Liver TransplantationPhase 4MAINNCT01339468
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
A Phase 4 study testing Advagraf and Prograf in people with Liver Transplantation, run by Astellas Pharma Inc at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Advagraf and Prograf
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2011to 27 May 2014
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject receiving a primary, partial liver graft from a living donor
- subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined
Who cannot join
- subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)
- subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
- subjects allergic or intolerant to macrolide antibiotics or tacrolimus
- subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation
- subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin
- subjects with systemic infection requiring treatment, except viral hepatitis
Show all 13Show fewer
- subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
- subjects with serum creatinine > 1.5mg/dl
- subjects taking or having taken potassium preserved diuretics
- subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
- subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days
- subjects or donors known to be HIV positive
- donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.
- Conditions
- Liver Transplantation
- Being tested
- Advagraf, Prograf
- Keywords
- advagraf, prograf, living donor liver transplantation, FK506, Immunosuppressant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Also called FK506E, modified release tacrolimus
oral
PrografDrug
Also called FK506, tacrolimus
oral
PrografDrug
Also called tacrolimus, FK506
intravenous
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Intravenous Prograf therapy followed by oral Advagraf therapy Receives: Drug: Advagraf; Drug: Prograf |
| Arm 2 | Active comparator | Intravenous Prograf therapy followed by oral Prograf therapy Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration
Measured: Day 6 and day 21
Secondary outcomes (4)
Cmax (maximum concentration) of tacrolimus plasma concentration
Measured: Day 6 and day 21
Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Measured: up to 24 weeks
Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Measured: up to 24 weeks
Safety assessed by the incidence of adverse events and lab-tests
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study start27 Apr 2011
- Primary completion27 May 2014
- Study completion27 May 2014
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339468
- Sponsor's protocol ID
- MR-08-04-KOR_Main
- Acronym
- MAIN
- Status last verified
- Jul 2017
- First submitted
- 12 Apr 2011
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Shin MH, Song GW, Lee SG, Hwang S, Kim KH, Ahn CS, Moon DB, Ha TY, Jung DH, Park GC, Yun YI, Kim WJ, Kang WH, Kim SH, Jiang H, Lee S, Tak EY. Once-daily, prolonged-release tacrolimus vs twice-daily, immediate-release tacrolimus in de novo living-donor liver transplantation: A Phase 4, randomized, open-label, comparative, single-center study. Clin Transplant. 2018 Sep;32(9):e13376. doi: 10.1111/ctr.13376. Epub 2018 Aug 26.
PubMed 30098071
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT01339468
- Acronym / sponsor ID
- MAIN / MR-08-04-KOR_Main
- Conditions
- Liver Transplantation
- Keywords
- advagraf, prograf, living donor liver transplantation, FK506, Immunosuppressant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2011 (actual)
- Primary completion
- 27 May 2014 (actual)
- Study completion
- 27 May 2014 (actual)
- First posted
- 20 Apr 2011 (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 investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor 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 |
|---|---|---|
| Arm 1 | Experimental | Drug: Advagraf, Drug: PrografIntravenous Prograf therapy followed by oral Advagraf therapy |
| Arm 2 | Active comparator | Drug: PrografIntravenous Prograf therapy followed by oral Prograf therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject receiving a primary, partial liver graft from a living donor
- subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined
Key exclusion criteria (13 listed)
- subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)
- subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
- subjects allergic or intolerant to macrolide antibiotics or tacrolimus
- subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation
- subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin
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 |
|---|---|---|
| AdvagrafAlso: FK506E, modified release tacrolimusoral | Drug | Arm 1 |
| PrografAlso: FK506, tacrolimusoral | Drug | Arm 2 |
| PrografAlso: tacrolimus, FK506intravenous | Drug | Arm 1, Arm 2 |
Primary outcome
AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration
Time frame: Day 6 and day 21
4 secondary outcomes
Cmax (maximum concentration) of tacrolimus plasma concentration
Time frame: Day 6 and day 21
Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Time frame: up to 24 weeks
Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Time frame: up to 24 weeks
Safety assessed by the incidence of adverse events and lab-tests
Time frame: up to 24 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 19 Jul 2017.
- Derived from this study: PubMed 30098071Shin MH, Song GW, Lee SG, Hwang S, Kim KH, Ahn CS, Moon DB, Ha TY, Jung DH, Park GC, Yun YI, Kim WJ, Kang WH, Kim SH, Jiang H, Lee S, Tak EY. Once-daily, prolonged-release tacrolimus vs twice-daily, immediate-release tacrolimus in de novo living-donor liver transplantation: A Phase 4, randomized, open-label, comparative, single-center study. Clin Transplant. 2018 Sep;32(9):e13376. doi: 10.1111/ctr.13376. Epub 2018 Aug 26.
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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 Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Advagraf and Prograf 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 19 Jul 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration (time frame: Day 6 and day 21). 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 NCT01339468, 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 19 Jul 2017.