A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus granules) in de novo Paediatric Allograft Recipients. - OPTION Version 1.0
- Conditions
- De novo allograft transplantation (liver, heart, kidney) in paediatric patients.
- Registration Number
- EUCTR2009-012258-19-GB
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 52
1. The subject is 12 years of age or younger.
2. 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.
3. 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. The subject has previously received another organ transplant (including liver, kidney or heart re-transplantation).
2. 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).
3. Cold ischemia time of the donor kidney greater than 30 hours (only applicable for renal transplant recipients).
4. Subject receives an AB0 incompatible donor organ.
5. 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).
6. Subject has significant liver disease, defined as having elevated ALT and/or 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).
7. Subject with pulmonary vascular resistance greater than 4 Wood units which is unresponsive to treatment.
8. Subjects with malignancies or a history of malignancy within the last 5 years.
9. 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.
10. Subject requires systemic immunosuppressive medication for any indication other than transplantation.
11. Recipient or donor known to be HIV, HCV or HBV positive.
12. Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab or tacrolimus.
13. Subject is currently participating in another clinical trial and/or has been taking an investigational drug in the 3 months prior to transplantation.
14. Subject is unlikely to comply with the visits scheduled in the protocol.
15. Subjects taking or requiring to be treated with medication or substances prohibited by the study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principal objective is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body. This is called pharmacokinetics (PK). The results will then help to decide how much Modigraf in future should be given to children and young people following transplantation.;Secondary Objective: Secondary objective of this study is gathering information on the safety and efficacy of Modigraf.;<br> Primary end point(s): PK parameters for tacrolimus will be determined after the morning dose on<br> Day 1 and Day 7 (+7 days):<br> - AUC tau<br> - C max<br> - t max<br> - C trough<br> Other PK parameters may be calculated where appropriate.<br>
- Secondary Outcome Measures
Name Time Method