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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- Percentage of Participants with Biopsy-Proven Acute Rejections (BPAR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •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.
研究组 & 干预措施
Liver Transplant
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.
干预措施: Tacrolimus granules (Drug)
Kidney Transplant
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.
干预措施: Tacrolimus granules (Drug)
结局指标
主要结局
Percentage of Participants with Biopsy-Proven Acute Rejections (BPAR)
时间窗: 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
时间窗: 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 with graft failure
时间窗: 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.
Percentage of Participants With Acute Rejection (AR)
时间窗: 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".
Number of Participants who Died
时间窗: 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 dose adjustments throughout the study period
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点