NCT01371344

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 0 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).

Detailed description

To monitor the safety and efficacy of Modigraf® (tacrolimus granules) in stable paediatric allograft recipients (Part A) and to monitor dose changes and tacrolimus whole blood trough levels after conversion from a Modigraf based Immunosuppression regimen to a Prograf® based Immunosuppression regimen (Part B).

Conditions

• Heart Transplantation
• Kidney Transplantation
• Liver Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus granules	oral
DRUG	Tacrolimus capsules	oral

Timeline

• Start date: 2011-06-24
• Primary completion: 2017-04-02
• Completion: 2017-04-02
• First posted: 2011-06-10
• Last updated: 2024-11-01

Locations

12 sites across 6 countries: Belgium, France, Germany, Poland, Spain, United Kingdom