Overview

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

Status:
Not yet recruiting

Trial end date:
2023-12-31

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Astellas Pharma China, Inc.

Treatments:

Tacrolimus