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
3 other identifiers
interventional
81
7 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2011
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Start
First participant enrolled
May 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2025
CompletedDecember 8, 2025
November 1, 2025
4.4 years
February 3, 2011
December 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Plasma Concentration-time Curve from Time 0 to Time 24 Hours (AUC0-24h) for Tacrolimus and Tacrolimus Prolonged Release
Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Secondary Outcomes (11)
Maximum Concentration (Cmax) of Tacrolimus and Tacrolimus Prolonged Release
Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Time to Attain Maximum Concentration (tmax) of Tacrolimus and Tacrolimus Prolonged Release
Day 7 (for tacrolimus) and day 14 (for tacrolimus prolonged release) at predose and 1, 2, 4, 6, 12, 13, 14, 16, 18 and 24 hours postdose
Trough Concentration (C24) for Tacrolimus and Tacrolimus Prolonged Release
Days 7 and 14, 24 hours after dosing
Number of Participants with Acute Rejections
Up to Week 54
Number of Participants with Biopsy Proven Acute Rejections (BPARs)
Up to Week 54
- +6 more secondary outcomes
Study Arms (1)
Tacrolimus Prolonged Release
EXPERIMENTALParticipants 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.
Interventions
Oral capsule
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Site BE21
Brussels, 1020, Belgium
Site BE22
Brussels, 1200, Belgium
Site CZ42
Prague, 150 06, Czechia
Site FR34
Bron, 69677, France
Site FR35
Bron, 69677, France
Site FR31
Paris, 75743, France
Site FR32
Paris, 75743, France
Site FR33
Paris, 75908, France
Site DE41
Heidelberg, 69120, Germany
Site IT74
Bergamo, 24127, Italy
Site IT75
Palermo, 90127, Italy
Site PL51
Warsaw, 04-730, Poland
Site PL52
Warsaw, 04-730, Poland
Site GB62
Birmingham, B4 6NH, United Kingdom
Site GB64
London, WC1 3JH, United Kingdom
Site GB61
Manchester, M27 4HA, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2011
First Posted
February 11, 2011
Study Start
May 25, 2011
Primary Completion
October 25, 2015
Study Completion
November 3, 2025
Last Updated
December 8, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.