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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20212678 | Registry Identifier | ChinaDrugTrials.org.cn | |
| 2022-002350-68 | Registry Identifier | EudraCT |
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The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or kidney transplantation. This study will also observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients.
Pediatric participants will be treated with a Modigraf (tacrolimus granules) based immunosuppressive regimen for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Transplant | Experimental | Pediatric participants who undergo de novo allograft liver transplantation receive initial daily dose of 0.2 milligram per kilogram (mg/kg) of body weight oral suspension of tacrolimus granules post-operatively for 12 months. |
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| Kidney Transplant | Experimental | Pediatric participants who undergo de novo allograft kidney transplantation receive initial daily dose of 0.2 mg/kg of body weight oral suspension of tacrolimus granules post-operatively for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus granules | Drug | Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of tacrolimus granules in whole blood: area under the blood concentration - time curve for a dosing interval (AUCtau) on Day 1 | AUCtau is recorded from the pharmacokinetic (PK) whole blood samples collected. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1 |
| PK of tacrolimus granules in whole blood: AUCtau on Day 7 | AUCtau is recorded from the PK blood samples collected. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7 |
| PK of tacrolimus granules in whole blood: maximum concentration (Cmax) on Day 1 | Cmax is recorded from the PK blood samples collected. Cmax is maximum concentration observed in an observation period. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1 |
| PK of tacrolimus granules in whole blood: Cmax on Day 7 | Cmax is recorded from the PK blood samples collected. Cmax is maximum concentration observed in an observation period. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7 |
| PK of tacrolimus granules in Whole Blood: Time of Maximum Concentration (Tmax) on Day 1 | Tmax is recorded from the PK blood samples collected. Tmax is time of maximum concentration in an observation period. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1 |
| PK of tacrolimus granules in Whole Blood: Tmax on Day 7 | Tmax is recorded from the PK blood samples collected. Tmax is time of maximum concentration in an observation period. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manager Medical Science | Astellas Pharma China, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CN86003 | Beijing | China | ||||
| Site CN86002 |
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| 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 |
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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.
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| Tacrolimus granules | Drug | Oral |
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| PK of tacrolimus granules in whole blood: Trough blood concentration (Ctrough) on Day 1 | Ctrough is recorded from the PK blood samples collected. | Pre-dose on day 1 |
| PK of granules tacrolimus in whole blood: Ctrough on Day 7 | Ctrough is recorded from the PK blood samples collected. | Pre-dose on day 7 |
| Correlation between Ctrough and AUCtau of tacrolimus granules PK parameters in whole blood on Day 1 | The correlation between Ctrough and AUCtau PK parameters will be assessed by Pearson's coefficient at each sample time by visit. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1 |
| 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 is 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 |
| Number of Participants who Died | Number of participant who died is recorded during 12 months' post-transplant; any cause of death is 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 or death, during the study period. A graft dysfunction to permanent dialysis in kidney transplantation is also considered as graft failure. | From first dose to month 12 |
| Number of Dose Adjustments Throughout the Study Period | The dose adjustments required for the organ transplant is reported. | 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 given 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 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. Mean trough levels of tacrolimus from day 1 through month 12 are reported. | From day 1 through month 12 (predose) |
| Correlation between Ctrough and AUCtau of tacrolimus granules in whole blood on Day 7 | The correlation between Ctrough and AUCtau is assessed by Pearson's coefficient at each sample time by visit. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7 |
| PK of tacrolimus granules in Whole Blood: Dose-normalized AUCtau on Day 1 | Dose-normalized AUCtau is AUCtau normalized with the dose just prior to blood sampling. Dose-normalized AUCtau is calculated as AUCtau/dose. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1 |
| PK of tacrolimus granules in Whole Blood: Dose-normalized AUCtau on Day 7 | Dose-normalized AUCtau is AUCtau normalized with the dose just prior to blood sampling. Dose-normalized AUCtau is calculated as AUCtau/dose. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7 |
| PK of tacrolimus granules in Whole Blood: Dose-normalized Cmax on Day 1 | Dose-normalized Cmax is Cmax normalized with the dose just prior to blood sampling. Dose-normalized Cmax is calculated as Cmax/dose. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1 |
| PK of tacrolimus granules in Whole Blood: Dose-normalized Cmax on Day 7 | Dose-normalized Cmax is Cmax normalized with the dose just prior to blood sampling. Dose-normalized Cmax is calculated as Cmax/dose. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7 |
| PK of tacrolimus granules in Whole Blood: Dose-normalized Ctrough on Day 1 | Ctrough normalized with the dose just prior to blood sampling. Dose-normalized Ctrough is calculated as Ctrough/dose. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 1 |
| PK of tacrolimus granules in Whole Blood: Dose-normalized Ctrough on Day 7 | Ctrough normalized with the dose just prior to blood sampling. Dose-normalized Ctrough is calculated as Ctrough/dose. | Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7 |
| 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 is 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 is 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 is performed by the local histopathologist following the "Histological Grading of Liver Biopsies for Rejection", the "Banff diagnostic categories for renal allograft biopsies". An AR is 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 |
| Guangzhou |
| China |
| Site CN86001 | Shanghai | China |
| Site CN86004 | Wuhan | China |