Liver TransplantationPhase 4AssignNCT04761731
To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
A Phase 4 study testing ADVAGRAF® in people with Liver Transplantation, run by Linical Korea.
Trial summary
This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new 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®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to 14 Dec 2017
- 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
- When the Subjects agree informed consent form, Subject should be More than 20 years of age
- Those who are transplanated liver at a minimum of 10 weeks or Maximum of 14 weeks of baseline
- Average of tacrorimus trough level is 3-10 ng/mL from transplanted date to before baseline.
- Female subjects of child bearing potential must have a negative urine or serum pregnancy test prior to enrolment and at the end of study and must agree to practice effective birth control during the study.(The oral contraceptive pill is not allowed to take a female subject) ⑤Subjects are stable clinically in the opinion of the investigator. ⑥Subjects capable of understanding the purpose and risks of the study, having been fully informed and has given written informed consent to participate in the study
Who cannot join
- Subjects having previously received an organ transplant excluding liver transplant. Or Subjects receiving an auxiliary graft or in whom a bio-artificial liver(cell system) has been used.
- Acute rejection from transplanted date to before baseline
- Subjects diagnosed new malignant tumor after liver transplantation, with the exception of basalioma or squamous cell carcinoma of the skin that has been treated successfully.
- Subjects allergic to tacrolimus or investigational product.
- Subjects are unstable clinically state in the opinion of the investigator.
- Subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
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- ⑦Subjects 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.
- ⑧Subjects taking forbidden concomitant medications or within 28 days prior to enroll.
- Subjects who are pregnant or breast-feeding mother.
- ⑩Subjects known to be HIV positive.
- ⑪Subjects unlikely to comply with the visits scheduled in the protocol.
- ⑫Subjects with renal dysfunction on the investigator's point of view or serum creatinine > 1.6mg/dL or GFR(MDRD)<30mL/min in the baseline.
- ⑬Hepatic dysfunction: rising more than triple the normal range of SGPT/ALT and/or SGOT/AST and/or bilirubin, hepatic cirrhosis
About this study
Official title: A Single Center, Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus Modified Release, ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
This study's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients.
Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.
Read the detailed description
This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set * 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions.
Administration method is following The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).
- Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment.
- Duration of treatment The investigational product will be administered for 24 weeks.
- Conditions
- Liver Transplantation
- Being tested
- ADVAGRAF®
- Keywords
- ADVAGRAF®, liver transplantation, tacrolimus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADVAGRAF®Drug
Also called tacrolimus
Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).
- Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment.
- Duration of treatment The investigational product will be administered for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ADVAGRAF® | Experimental | One arm: Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients. Receives: Drug: ADVAGRAF® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of biopsy confirmed acute rejection
Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set * 100
Measured: 24 weeks within
Secondary outcomes (3)
Severity of biopsy confirmed acute rejection
Severity of acute rejection reactions is defined as the highest severity in a subject who had at least one acute rejection reaction.
Measured: within 24 weeks
Survival rates of subjects and transplanted organs
The survival rate of transplant organs is determined by the loss of transplant organs in the 24th week. Transplant organ loss is defined as re-transplant surgery or death. The date of the transplant's disappearance is the first time one of these events has occurred.
Measured: at 24 weeks
compliance
The dosage compliance level is checked by the questionnaire at each visit based on the total amount of the IPs that should have been taken.
Measured: at 24 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 2021
- Study startJul 2015
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
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 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linical Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc., National Cancer Center, Korea
- Responsible party
- Sponsor
- Investigators
- seoung hoon Kim, doctoral, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761731
- Sponsor's protocol ID
- Assign
- Acronym
- Assign
- Status last verified
- Feb 2021
- First submitted
- 17 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus Modified Release, ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT04761731
- Acronym / sponsor ID
- Assign / Assign
- Conditions
- Liver Transplantation
- Keywords
- ADVAGRAF®, liver transplantation, tacrolimus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Linical KoreaIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc., National Cancer Center, Korea
- Study start
- Jul 2015
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 21 Feb 2021 (actual)
- 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's objective is to evaluate the incidence rate of acute rejection reactions after 24 weeks treatment with ADVAGRAF® following 3 months treatment with tacrolimus in new liver transplant recipients.
Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients.
Detailed description
This is single center,open-label study with ADVAGRAF® Primary endpoint is Incidence rate of biopsy confirmed acute rejection reactions within 24 weeks following conversion+ Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set * 100 Only those acute rejection reactions confirmed by biopsy will be acceptable as acute rejection reactions.
Administration method is following The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).
- Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment.
- Duration of treatment The investigational product will be administered for 24 weeks.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADVAGRAF® | Experimental | Drug: ADVAGRAF®One arm: Treatment conversion will take place from twice daily tacrolimus to once daily tacrolimus (ADVAGRAF) 3 months after transplant in new liver transplant recipients. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- When the Subjects agree informed consent form, Subject should be More than 20 years of age
Key exclusion criteria (13 listed)
- Subjects having previously received an organ transplant excluding liver transplant. Or Subjects receiving an auxiliary graft or in whom a bio-artificial liver(cell system) has been used.
- ⑦Subjects 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.
- ⑧Subjects taking forbidden concomitant medications or within 28 days prior to enroll.
- ⑩Subjects known to be HIV positive.
- ⑪Subjects unlikely to comply with the visits scheduled in the protocol.
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 |
|---|---|---|
| ADVAGRAF®Also: tacrolimusAdministration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast). * Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment. * Duration of treatment The investigational product will be administered for 24 weeks. | Drug | ADVAGRAF® |
Primary outcome
Incidence rate of biopsy confirmed acute rejection
Time frame: 24 weeks within
Incidence rate of acute rejection reactions (%) = number of subjects with at least one acute rejection reaction 1)/total number of subjects in the relevant analysis set * 100
3 secondary outcomes
Severity of biopsy confirmed acute rejection
Time frame: within 24 weeks
Survival rates of subjects and transplanted organs
Time frame: at 24 weeks
compliance
Time frame: at 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 21 Feb 2021.
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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.
seoung hoon Kim, doctoral principal investigator
National Cancer Center, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ADVAGRAF® in people with Liver Transplantation, run by Linical 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 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence rate of biopsy confirmed acute rejection (time frame: 24 weeks within). 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 21 Feb 2021.