Liver TransplantationPhase 4NCT05153915
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
A Phase 4 study testing Tacrolimus granules in people with Liver Transplantation and Kidney Transplantation, run by Astellas Pharma China, Inc. at 7 sites in China.
Trial summary
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Liver Transplantation, Kidney Transplantation
- What is being tested?
- Tacrolimus granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesChina
- Study dates
- 30 Dec 2021to 14 Mar 2024
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant's parent(s) or their legal representative(s), and participant where applicable agrees not to participate in another interventional study while participating in the present study from 1 month before screening to the end of the study.
Who cannot join
- Participant has previously received another organ transplant.
- Participant has a high immunological risk, defined as a panel reactive antibody (PRA) score > 50% in the previous 6 months (only applicable for kidney transplantation recipients).
- Cold ischemia time of the donor kidney longer than 30 hours (only applicable for kidney transplantation recipients).
- Bilateral kidney transplantation recipients (only applicable for kidney transplantation recipients).
- Participant receives an ABO incompatible donor organ.
- Participant has significant kidney impairment, defined as having serum creatinine ≥ 230 μmol/L (≥ 2.6 mg/dL) prior to transplantation (not applicable for kidney transplantation recipients).
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- Participant has significant liver disease, defined as having elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBL) levels 3 times the upper value of the normal range prior to transplantation (not applicable for liver transplantation recipients).
- Participants with malignancies or a history of malignancy within the last 5 years.
- Participant has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer.
- Recipient or donor known to be human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) positive.
- Participant requires systemic immunosuppressive medication for any indication other than transplantation.
- Participants taking or requiring to be treated with medication or substances prohibited by this protocol.
- Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab, or tacrolimus.
- Participants with severe primary disease/complications/poor general condition which may be unsuitable for participating in this study.
- Participant is currently participating in another clinical trial and/or has been taking any other study drug within 1 month prior to screening.
- Participant is unlikely to comply with the visits scheduled in the protocol.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Site CN86003
Beijing
Site CN86006
Changsha
Site CN86001
Guangzhou
Site CN86002
Shanghai
Site CN86007
Tianjin
Site CN86004
Wuhan
Site CN86005
Zhengzhou
About this study
Official title: A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen.
- Conditions
- Liver Transplantation, Kidney Transplantation
- Being tested
- Tacrolimus granules
- Keywords
- Liver Transplantation, Kidney Transplantation, Modigraf, Tacrolimus, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus granulesDrug
Also called Modigraf
Oral
Tacrolimus granulesDrug
Also called Modigraf
Oral
| Study group | Role | What they receive |
|---|---|---|
| Liver Transplant | Experimental | Pediatric participants who undergo de novo allograft liver transplantation receive initial daily dose of 0.15 to 0.3 milligram per kilogram (mg/kg) of body weight oral suspension of tacrolimus granules post-operatively for 12 months. Receives: Drug: Tacrolimus granules |
| Kidney Transplant | Experimental | Pediatric participants who undergo de novo allograft kidney transplantation receive initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months. Receives: Drug: Tacrolimus granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Acute Rejection (AR)
AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the "Histological Grading of Liver Biopsies for Rejection", the "Banff diagnostic categories for renal allograft biopsies".
Measured: From first dose to month 12
Percentage of Participants with Biopsy-Proven Acute Rejections (BPAR)
AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the "Histological Grading of Liver Biopsies for Rejection", the "Banff diagnostic categories for renal allograft biopsies". A BPAR episode was defined as any AR episode confirmed by biopsy.
Measured: From first dose to month 12
Percentage of Participants with clinically suspected Rejection
AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the "Histological Grading of Liver Biopsies for Rejection", the "Banff diagnostic categories for renal allograft biopsies". An AR was clinically suspected in participants who experienced an increase in serum creatinine, after the exclusion of other causes of graft dysfunction (generally with biopsy).
Measured: From first dose to month 12
Number of Participants who Died
Number of participants who died is recorded during 12 months' post-transplant; any cause of death was taken into account.
Measured: From first dose to month 12
Number of participants with graft failure
Graft failure is defined as graft dysfunction including re-transplantation, graft loss or death, during the study period. A graft dysfunction to permanent dialysis in kidney transplantation was also considered as graft failure.
Measured: From first dose to month 12
Number of dose adjustments throughout the study period
The number of dose changes will The dose adjustments required for the organ transplant were reported. The Safety Analysis Set (SAF) consisted of all participants who took at least one dose of study drug.
Measured: From first dose to month 12
Number of participants with Treatment Emergent adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a study drug not necessarily linked to this treatment. An AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Treatment emergent adverse event (TEAE) is defined as AE observed after administering the study drug.
Measured: From first dose to month 12
Whole Blood Trough Levels of Tacrolimus
Tacrolimus whole blood trough levels are routinely monitored from whole blood samples, using a local assay method, for example EMITÒ or Liquid-Chromatography-Mass-Spectrometry-Mass-Spectrometry (LC-MS-MS) in the local laboratories.
Measured: From month 1 through month 12 (predose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start30 Dec 2021
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manager Medical Science, Study director, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153915
- Sponsor's protocol ID
- F506-CL-0406
- Other IDs
- CTR20212679, 2022-002351-19
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2021
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
- ClinicalTrials.gov ID
- NCT05153915
- Acronym / sponsor ID
- F506-CL-0406
- Conditions
- Liver Transplantation, Kidney Transplantation
- Keywords
- Liver Transplantation, Kidney Transplantation, Modigraf, Tacrolimus, Pediatric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 10 Dec 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.
The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver Transplant | Experimental | Drug: Tacrolimus granulesPediatric participants who undergo de novo allograft liver transplantation receive initial daily dose of 0.15 to 0.3 milligram per kilogram (mg/kg) of body weight oral suspension of tacrolimus granules post-operatively for 12 months. |
| Kidney Transplant | Experimental | Drug: Tacrolimus granulesPediatric participants who undergo de novo allograft kidney transplantation receive initial daily dose of 0.15 to 0.3 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participant's parent(s) or their legal representative(s), and participant where applicable agrees not to participate in another interventional study while participating in the present study from 1 month before screening to the end of the study.
Key exclusion criteria (16 listed)
- Participant has previously received another organ transplant.
- Participant has a high immunological risk, defined as a panel reactive antibody (PRA) score > 50% in the previous 6 months (only applicable for kidney transplantation recipients).
- Cold ischemia time of the donor kidney longer than 30 hours (only applicable for kidney transplantation recipients).
- Bilateral kidney transplantation recipients (only applicable for kidney transplantation recipients).
- Participant receives an ABO incompatible donor organ.
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 |
|---|---|---|
| Tacrolimus granulesAlso: ModigrafOral | Drug | Liver Transplant |
| Tacrolimus granulesAlso: ModigrafOral | Drug | Kidney Transplant |
Primary outcome
Percentage of Participants With Acute Rejection (AR)
Time frame: From first dose to month 12
AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the "Histological Grading of Liver Biopsies for Rejection", the "Banff diagnostic categories for renal allograft biopsies".
Percentage of Participants with Biopsy-Proven Acute Rejections (BPAR)
Time frame: From first dose to month 12
AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the "Histological Grading of Liver Biopsies for Rejection", the "Banff diagnostic categories for renal allograft biopsies". A BPAR episode was defined as any AR episode confirmed by biopsy.
Percentage of Participants with clinically suspected Rejection
Time frame: From first dose to month 12
AR is an immune response against the donor graft that causes tissue impairment and potential failure. The criteria for rejection was performed by the local histopathologist following the "Histological Grading of Liver Biopsies for Rejection", the "Banff diagnostic categories for renal allograft biopsies". An AR was clinically suspected in participants who experienced an increase in serum creatinine, after the exclusion of other causes of graft dysfunction (generally with biopsy).
Number of Participants who Died
Time frame: From first dose to month 12
Number of participants who died is recorded during 12 months' post-transplant; any cause of death was taken into account.
Number of participants with graft failure
Time frame: From first dose to month 12
Graft failure is defined as graft dysfunction including re-transplantation, graft loss or death, during the study period. A graft dysfunction to permanent dialysis in kidney transplantation was also considered as graft failure.
Number of dose adjustments throughout the study period
Time frame: From first dose to month 12
The number of dose changes will The dose adjustments required for the organ transplant were reported. The Safety Analysis Set (SAF) consisted of all participants who took at least one dose of study drug.
Number of participants with Treatment Emergent adverse events (AEs)
Time frame: From first dose to month 12
An AE is defined as any untoward medical occurrence in a participant administered a study drug not necessarily linked to this treatment. An AE can be any unfavorable and unintended sign (e.g., abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Treatment emergent adverse event (TEAE) is defined as AE observed after administering the study drug.
Whole Blood Trough Levels of Tacrolimus
Time frame: From month 1 through month 12 (predose)
Tacrolimus whole blood trough levels are routinely monitored from whole blood samples, using a local assay method, for example EMITÒ or Liquid-Chromatography-Mass-Spectrometry-Mass-Spectrometry (LC-MS-MS) in the local laboratories.
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 17 Mar 2025.
- Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
- Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Manager Medical Science study director
Astellas Pharma China, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus granules in people with Liver Transplantation and Kidney Transplantation, run by Astellas Pharma China, Inc. at 7 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 1 inclusion and 16 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Percentage of Participants With Acute Rejection (AR) (time frame: From first dose to month 12). The study lists 8 primary outcomes in all. 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 17 Mar 2025.