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

• Status: Active, not recruiting
• Trial end date: 2026-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe Ltd.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Must be able to swallow intact study medication capsules

• Received a single solid organ transplant at least 6 months prior to entry into the study

• The subject's parent(s), or their legal representative(s), has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable

• Has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months

• Negative pregnancy test prior to enrolment (females)

• Must agree to practice effective birth control during the study

• Stable whole blood trough levels of tacrolimus in the range of 3.5 - 15ng/mL (+/-0.5ng/mL) and clinically stable in the opinion of the Investigator

Exclusion Criteria:

• Previously received a multiple organ transplant

• Any rejection episode within 3 months prior to enrolment or within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months

• Currently receiving Rapamycin, Certican or MPA (Myfortic®)

• Chronic dysfunction of the allograft, in the opinion of the Investigator

• Major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study

• The subject is pregnant or breast feeding