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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Oral
Oral
Site CN86003
Beijing, China
Site CN86006
Changsha, China
Site CN86001
Guangzhou, China
Site CN86002
Shanghai, China
Site CN86007
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".
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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Tianjin, China
Site CN86004
Wuhan, China
Site CN86005
Zhengzhou, China
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From month 1 through month 12 (predose)