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Completed
NCT01294020
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Conditions: Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation, Heart Transplantation
Sex: All
Ages: 5 Years – 16 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 81
Sponsor: Astellas Pharma Europe Ltd.
Location: Site BE21 Brussels
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT01294020). StuddyBuddy aggregates publicly available trial information.