Clinical trial NCT01371344: A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients
Official title: A Long-term, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in Paediatric Solid Allograft Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Transplantation
Kidney Transplantation
Liver Transplantation
Keywords: Liver Transplantation
Kidney Transplantation
Heart Transplantation
Pharmacokinetics
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 47
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study, a follow up to study FG506-CL-0403, is to see how safe and effective Modigraf® is (Part A) and to see how safe and effective it is to change your child's medication from Modigraf® to Prograf® (Part B).

Detailed description: To monitor the safety and efficacy of Modigraf® (tacrolimus granules) in stable paediatric allograft recipients (Part A) and to monitor dose changes and tacrolimus whole blood trough levels after conversion from a Modigraf based Immunosuppression regimen to a Prograf® based Immunosuppression regimen (Part B).

Eligibility criteria: Inclusion Criteria:

F506-CL-0404 Part A

* Subject was ≤12 years of age at enrolment into study F506-CL-0403
* Subject received at least one dose of Modigraf in the F506-CL-0403 study

F506-CL-0404 Part B

* Subject received at least one dose of Modigraf in the F506-CL-0403 study
* Subject participated in F506-CL-0404 Part A
* Subject has continuously been dosed with Twice daily (BID) Modigraf since the End of Study Visit for Part A (ESVA) from F506-CL-0404 Part A
* Subject is stable and has had no dose changes in the preceding 2 weeks

Exclusion Criteria:

F506-CL-0404 Part A

* As all subjects included in this study conform to the exclusion criteria in study F506-CL-0403, hence no specific exclusion criteria are relevant for this study

F506-CL-0404 Part B

* There are no specific exclusion criteria for this study

Primary outcomes:
measure: Part A: Number of Participants with Acute Rejection Episodes
timeFrame: Up to 12 months
measure: Part A; Number of Participants with Biopsy-proven Acute Rejection Episodes (BPARs)
timeFrame: Up to 12 months
measure: Part A: Severity of BPARs
timeFrame: Up to 12 months
measure: Part A: Patient Survival
timeFrame: Up to 12 months
measure: Part A: Graft Survival
timeFrame: Up to 12 months
measure: Part A: Number of Participants with Adverse Events (AEs)
timeFrame: From first dose of study drug up to 30 days after last dose of study drug (up to 13 months)
measure: Part A: Tacrolimus Mean Trough Levels
timeFrame: Day 1, months 1, 2, 3, 6, 9, 12 (prior to each study drug dosing)
measure: Part A: Number of Dose Adjustments
timeFrame: Months 1, 2, 3, 6, 9, 12
measure: Part B: Number of Participants with AEs
timeFrame: From first dose of study drug (tacrolimus capsules) up to 7 days after last dose (up to 38 days)
measure: Part B: Tacrolimus Trough Levels Prior to and After Conversion
timeFrame: Day -1 up to 1 month
measure: Part B: Number of Dose Adjustments
timeFrame: From first dose of study drug up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Site BE40 Clinique Univ. Saint Luc
city: Bron
country: France
facility: Site FR60 Groupement Hospitalier EST
city: Paris Cedex 19
country: France
facility: Site FR61 Hopital Robert Debre
city: Hannover
country: Germany
facility: Site DE31 Kliniken der Medizinischen Hoc
city: Heidelberg
country: Germany
facility: Site DE30 Universitätsklin Heidelberg
city: Warsaw
country: Poland
facility: Site PL50 Centrum Zdrowia Dziecka
city: Madrid
country: Spain
facility: Site ES22 H.U. Gregorio Maranon
city: Madrid
country: Spain
facility: Site ES20 Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Site ES21 Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Site ES23 Hospital Universitario La Paz
city: Liverpool
country: United Kingdom
facility: Site GB14 Alder Hey Children Hospital
city: Manchester
country: United Kingdom
facility: Site GB13 Cent. Manchester Uni. Hospital
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Senior Study Manager
role: STUDY_DIRECTOR
References: