NCT05153915

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

A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tacrolimus granules	Oral
DRUG	Tacrolimus granules	Oral

Timeline

• Start date: 2021-12-30
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2021-12-10
• Last updated: 2025-03-17

Locations

7 sites across 1 country: China