A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

NCT ID: NCT05152628

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2024-03-06

Brief Summary

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.

Detailed Description

Pediatric participants will be treated with a Modigraf (tacrolimus granules) based immunosuppressive regimen for 12 months.

Conditions

Liver Transplantation; Kidney Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liver Transplant

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.

Group Type: EXPERIMENTAL

Tacrolimus granules

Intervention Type: DRUG

Oral

Kidney Transplant

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.

Group Type: EXPERIMENTAL

Tacrolimus granules

Intervention Type: DRUG

Oral

Interventions

Tacrolimus granules

Oral

Intervention Type: DRUG

Tacrolimus granules

Oral

Intervention Type: DRUG

Other Intervention Names

Modigraf; Modigraf

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma China, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manager Medical Science

Role: STUDY_DIRECTOR

Astellas Pharma China, Inc.

Locations

Site CN86003

Beijing, , China

Site CN86002

Guangzhou, , China

Site CN86001

Shanghai, , China

Site CN86004

Wuhan, , China

Countries

China

Related Links

https://www.clinicaltrials.astellas.com/study/F506-CL-0405/

Link to results and other applicable study documents on the Astellas Clinical Trials website

https://www.trialsummaries.com/Study/StudyDetails?id=26483&tenant=MT_AST_9011

Link to plain language summary of the study on the Trial Results Summaries website

Other Identifiers

CTR20212678

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-002350-68

Identifier Type: REGISTRY

Identifier Source: secondary_id

F506-CL-0405

Identifier Type: -

Identifier Source: org_study_id