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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 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-03-17

No results posted yet for this study

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

Interventions

DRUG

Tacrolimus granules

Oral

DRUG

Tacrolimus granules

Oral

Sponsors & Collaborators

  • Astellas Pharma China, Inc.

    lead INDUSTRY

Principal Investigators

  • Manager Medical Science · Astellas Pharma China, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2024-03-14
Completion
2024-03-14

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05153915 on ClinicalTrials.gov