Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
NCT ID: NCT01294020
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2011-05-25
2025-11-03
Brief Summary
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Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Tacrolimus Prolonged Release
Participants receive tacrolimus prolonged release once daily starting from day 1 for 4 weeks for in Part A, and continue to receive tacrolimus prolonged release once daily up to end of Part B of the study.
Tacrolimus
Oral capsule
Tacrolimus prolonged release
Oral capsule
Interventions
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Tacrolimus
Oral capsule
Tacrolimus prolonged release
Oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
16 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe Ltd.
Locations
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Site BE21
Brussels, , Belgium
Site BE22
Brussels, , Belgium
Site CZ42
Prague, , Czechia
Site FR34
Bron, , France
Site FR35
Bron, , France
Site FR31
Paris, , France
Site FR32
Paris, , France
Site FR33
Paris, , France
Site DE41
Heidelberg, , Germany
Site IT74
Bergamo, , Italy
Site IT75
Palermo, , Italy
Site PL51
Warsaw, , Poland
Site PL52
Warsaw, , Poland
Site GB62
Birmingham, , United Kingdom
Site GB64
London, , United Kingdom
Site GB61
Manchester, , United Kingdom
Countries
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Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2010-020925-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-517571-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
PMR-EC-1206
Identifier Type: -
Identifier Source: org_study_id
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