Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Astellas Pharma Europe Ltd. (Voir sur ClinicalTrials)
mai 2011
décembre 2025
12 avril 2025
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Site FR31 - 75743 - Paris Cedex 15 - France | Contact (sur clinicalTrials) | ||||
| Site FR32 - 75743 - Paris Cedex 15 - France | Contact (sur clinicalTrials) | ||||
| Site FR33 - 75908 - Paris Cedex 15 - France | Contact (sur clinicalTrials) | ||||
| Site FR34 - 69677 - Bron Cedex - France | Contact (sur clinicalTrials) | ||||
| Site FR35 - 69677 - BRON Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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