A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
OPTION
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients
2 other identifiers
interventional
52
6 countries
10
Brief Summary
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2011
Longer than P75 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2011
CompletedStudy Start
First participant enrolled
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2015
CompletedNovember 1, 2024
October 1, 2024
3.7 years
June 9, 2011
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Determine AUCtau (area under the plasma concentration-time curve for a dosing interval)
on Day 1 and Day 7 (+/- 7 days)
Determine Cmax (maximum concentration)
on Day 1 and Day 7 (+/- 7 days)
Determine tmax (time to attain Cmax)
on Day 1 and Day 7 (+/- 7 days)
Determine Ctrough (plasma concentration at the end of a dosing interval)
on Day 1 and Day 7 (+/- 7 days)
Secondary Outcomes (4)
Rejection episodes
14 days
Patient survival
14 days
Graft survival
14 days
Assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs
14 days
Study Arms (1)
Tacrolimus granules
EXPERIMENTALoral
Interventions
Eligibility Criteria
You may qualify if:
- The subject is the recipient of a solid organ (liver, kidney or heart) transplant. Multiorgan transplants are acceptable as long as one of the organs transplanted is liver, kidney or heart
You may not qualify if:
- The subject has previously received another organ transplant (including liver, kidney or heart re-transplantation)
- Subject has a high immunological risk, defined as a Panel Reactive Antibody (PRA) score \>50% in the previous 6 months (only applicable for renal transplant recipients)
- Cold ischemia time of the donor kidney greater than 30 hours (only applicable for renal transplant recipients)
- Subject receives an AB0 incompatible donor organ
- Subject has significant renal impairment, defined as having serum creatinine ≥230 μmol/l (≥2.6 mg/dl) pre-transplantation (not applicable for renal transplant recipients)
- Subject has significant liver disease, defined as having elevated Alanine Aminotransferase (ALT) and/or Asparate Aminotransferase (AST) and/or Total Bilirubin levels 3 times the upper value of the normal range during the 28 days prior to transplantation (not applicable for liver transplant recipients)
- Subject with pulmonary vascular resistance greater than 4 Wood units which is unresponsive to treatment
- Subjects with malignancies or a history of malignancy within the last 5 years
- Subject has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer
- Subject requires systemic immunosuppressive medication for any indication other than transplantation
- Recipient or donor known to be HIV, HCV or HBV positive
- Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab or tacrolimus
- Subject is currently participating in another clinical trial and/or has been taking an investigational drug in the 3 months prior to transplantation
- Subject is unlikely to comply with the visits scheduled in the protocol
- Subjects taking or requiring to be treated with medication or substances prohibited by this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Site 40
Brussels, 1200, Belgium
Site: 60
Bron, 69677, France
Site 31
Hanover, 30625, Germany
Site 30
Heidelberg, 69120, Germany
Site 50
Warsaw, 04-730, Poland
Site 22
Madrid, 28007, Spain
Site 20
Madrid, 28046, Spain
Site 21
Madrid, 28046, Spain
Site 10
Birmingham, B4 6NH, United Kingdom
Site 13
Manchester, M13 9WL, United Kingdom
Related Publications (1)
Webb NJA, Baumann U, Camino M, Frauca E, Undre N; OPTION Study Group. Pharmacokinetics of tacrolimus granules in pediatric de novo liver, kidney, and heart transplantation: The OPTION study. Pediatr Transplant. 2019 Feb;23(1):e13328. doi: 10.1111/petr.13328. Epub 2019 Jan 21.
PMID: 30665258DERIVED
Related Links
Study Officials
- STUDY CHAIR
Senior Study Manager
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 10, 2011
Study Start
June 9, 2011
Primary Completion
February 3, 2015
Study Completion
February 3, 2015
Last Updated
November 1, 2024
Record last verified: 2024-10
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/.