A Phase 4 interventional study of Tacrolimus granules and Tacrolimus granules in Liver Transplantation and Kidney Transplantation, sponsored by Astellas Pharma China, Inc.. Completed at 4 sites in China. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Astellas Pharma China, Inc. · Phase 4, Interventional, and Treatment
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.
Astellas Pharma China, Inc. is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Tacrolimus granules
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.
Drug: Tacrolimus granules
Oral
Also known as: Modigraf
Oral
Also known as: Modigraf
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose, 0.5, 1, 2, 8, 12 hours post dose on day 7
PK of tacrolimus granules in whole blood: Trough blood concentration (Ctrough) on Day 1
Ctrough is recorded from the PK blood samples collected.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: From first dose to month 12
Number of Dose Adjustments Throughout the Study Period
The dose adjustments required for the organ transplant is reported.
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 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.
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. Mean trough levels of tacrolimus from day 1 through month 12 are reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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 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).
Time frame: From first dose to month 12
Plan to share: 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/.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Astellas Pharma China, Inc.