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

Kidney Transplantation Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01371344
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Terminated
Phase Phase 4
Start date June 24, 2011
Completion date April 2, 2017
View Details
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