drugset / Trial / NCT01294020

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®

NCT01294020

Phase 2 Completed 81 enrolled Astellas Pharma Europe Ltd.
NaSingle-groupOpen-labelPrevention

Summary

Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy. Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.

Timeline

Start
2011-05-25
Primary completion
2015-10-25
Completion
2025-11-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Tacrolimus Small molecule Oral

Indications

No indication recorded.