NCT01294020

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

A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part A: On Day 1 subjects will be converted from their routine Prograf®-based immunosuppressive regimen to a Prograf®-based immunosuppressive regimen supplied by the Sponsor as study medication and continue treatment until Day 7. The daily dose of the study medication must be the same \[1:1 (mg:mg)\] as the Prograf® dose received during the 30-day screening period. On Day 7 the first 24 hour PK profile will be started. Samples will be taken over a 24 hour period and will be completed on Day 8. On Day 8 subjects will be switched to once-daily Advagraf® on a 1:1 (mg:mg) total daily dose basis and continue treatment until Day 14. On Day 14 the second 24-hour PK profile will be started. Samples will be taken over a 24-hour period and will be completed on Day 15. Part B: One year follow-up period to evaluate safety and efficacy of tacrolimus when administered as an Advagraf®-based immunosuppressive regimen. Part C: Continuation of long-term follow-up (from Day 365 onwards). Patients who have completed Part B and to whom continued treatment with Advagraf® is not currently available, will be offered participation in a continuation of long-term follow-up (Part C). Part C will continue until Advagraf® becomes available to these patients or these patients' discontinuation, whichever is the earliest. Part C applies to patients in the following countries: United Kingdom, Czech Republic, Germany, Italy, and Poland only.

Conditions

• Intestine Transplantation
• Kidney Transplantation
• Lung Transplantation
• Liver Transplantation
• Heart Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus	Oral capsule
DRUG	Tacrolimus prolonged release	Oral capsule

Timeline

• Start date: 2011-05-25
• Primary completion: 2015-10-25
• Completion: 2025-11-03
• First posted: 2011-02-11
• Last updated: 2025-12-08

Locations

16 sites across 7 countries: Belgium, Czechia, France, Germany, Italy, Poland, United Kingdom