drugset / Trial / NCT01371344
A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients
Non-randomizedSingle-groupOpen-labelPrevention
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).
Timeline
- Start
- 2011-06-24
- Primary completion
- 2017-04-02
- Completion
- 2017-04-02
Outcome
Outcome not reported
Stopped: “Trial will not complete until at least 2025 and evolution of immunosuppressant therapy has made it unlikely that patients will convert from Modigraf to Prograf.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tacrolimus | Small molecule | — | Oral |
Indications
No indication recorded.