Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20212679 | Registry Identifier | ChinaDrugTrials.org.cn | |
| 2022-002351-19 | Registry Identifier | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus granules | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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. | 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). | 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. | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Manager Medical Science | Astellas Pharma China, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CN86003 | Beijing | China | ||||
| Site CN86006 |
Not provided
| Label | URL |
|---|---|
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
Not provided
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/.
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tacrolimus granules | Drug | Oral |
|
|
| 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. | 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. | 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 EMITÃ’ or Liquid-Chromatography-Mass-Spectrometry-Mass-Spectrometry (LC-MS-MS) in the local laboratories. | From month 1 through month 12 (predose) |
| Changsha |
| China |
| Site CN86001 | Guangzhou | China |
| Site CN86002 | Shanghai | China |
| Site CN86007 | Tianjin | China |
| Site CN86004 | Wuhan | China |
| Site CN86005 | Zhengzhou | China |