A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

NCT05153915 | Completed Phase 4

• 3 other identifiers: F506-CL-0406CTR202126792022-002351-19
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Liver Transplantation; Kidney Transplantation

Keywords

Liver Transplantation; Kidney Transplantation; Modigraf; Tacrolimus; Pediatric

Outcome Measures

Primary Outcomes (8)

• 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.

  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 EMITÒ or Liquid-Chromatography-Mass-Spectrometry-Mass-Spectrometry (LC-MS-MS) in the local laboratories.

  From month 1 through month 12 (predose)

Study Arms (2)

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.

Drug: Tacrolimus granules

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.

Drug: Tacrolimus granules

Interventions

Tacrolimus granules DRUG

Oral

Also known as: Modigraf

Liver Transplant

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (7)

Site CN86003

Beijing, China

Location

Site CN86006

Changsha, China

Location

Site CN86001

Guangzhou, China

Location

Site CN86002

Shanghai, China

Location

Site CN86007

Tianjin, China

Location

Site CN86004

Wuhan, China

Location

Site CN86005

Zhengzhou, China

Location

Related Links

• Link to results and other applicable study documents on the Astellas Clinical Trials website
• Link to plain language summary of the study on the Trial Results Summaries website

Study Officials

• Manager Medical Science

  Astellas Pharma China, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 10, 2021
• Study Start: December 30, 2021
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (7)