NCT05152628

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

A Multicenter, Open-label, Non-comparative 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Astellas Pharma China, Inc. · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Tacrolimus granules	Oral
DRUG	Tacrolimus granules	Oral

Timeline

• Start date: 2022-01-11
• Primary completion: 2024-03-06
• Completion: 2024-03-06
• First posted: 2021-12-10
• Last updated: 2025-03-17

Locations

4 sites across 1 country: China