Prophylaxis of primary liver, kidney, heart, lung, and intestinal organ transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10052062 Term: Prophylaxis against intestinal transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050432 Term: Prophylaxis against heart transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050433 Term: Prophylaxis against lung transplant rejection MedDRA version: 12.1 Level: LLT Classification code 10050
Conditions
Sponsors
Astellas Pharma Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is at least 5 years and not older than 16 years of age, inclusive. 2. The subject must be able to swallow intact study medication capsules. 3. The subject received a single solid organ transplant at least 6 months prior to entry into the study. 4. 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. 5. The subject has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months. 6. Female subjects of child bearing potential must provide a negative urine or serum pregnancy test prior to enrolment in the study 7. Male and female subjects that are sexually active must agree to practice effective birth control during the study. (An effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner). 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
Exclusion criteria
Exclusion criteria: 1. The subject has previously received a multiple organ transplant. 2. The subject has experienced any rejection episode within 3 months prior to enrolment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months. 3. The subject is currently receiving Rapamycin, Certican or MPA (Myfortic®). 4. The subject has a chronic dysfunction of the allograft, in the opinion of the Investigator. 5. The subject had major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study (a major change in immunosuppressive medication would be defined as addition, removal or substitution of any immunosuppressive agent from the regimen, but would not include dose changes of current immunosuppressive medications). 6. The subject has any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator. 7. The subject is known to be positive for either HBV or HCV or HIV. 8. The subjects is required to be treated with medication or substances known to interfere with tacrolimus metabolism as listed in Appendix 1, or having taken such medication within 28 days prior to inclusion. 9. The subject is pregnant or breast feeding. 10. The subject has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator. 11. The subject is participating or has participated in another clinical trial and/or is taking or has taken an investigational/non-registered drug in the past 28 days. 12. The subject is unlikely to comply with the visits scheduled in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the steady state AUC0-24h of tacrolimus for Advagraf® with that of Prograf® in stable pediatric allograft recipients after 1:1 (mg:mg) conversion from Prograf® to Advagraf®;Secondary Objective: To observe the long-term safety and efficacy profile of tacrolimus for Advagraf® in stable pediatric allograft recipients after 1:1 (mg:mg) conversion from Prograf® to Advagraf® and to evaluate the relationship between AUC0-24h and C24 for Advagraf® and for Prograf® at each PK profile.;Primary end point(s): The steady state systemic exposure (AUC0-24h) of tacrolimus when administered as Advagraf® or Prograf® in stable pediatric allograft recipients. | — |
Countries
Austria, Belgium, Czech Republic, France, Germany, Italy, United Kingdom
Outcome results
None listed