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).
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
47
oral
oral
Site BE40 Clinique Univ. Saint Luc
Brussels, Belgium
Site FR60 Groupement Hospitalier EST
Bron, France
Site FR61 Hopital Robert Debre
Paris, France
Part A: Number of Participants with Acute Rejection Episodes
Rejection episodes/acute rejections are indicated by clinical and/or laboratory signs, and are classified according to their rejection specific treatment: •Spontaneously Resolving Acute Rejection: not treated with new or increased corticosteroid medication, antibodies or any other medication and resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Sensitive Acute Rejection: treated with new or increased corticosteroid medication only and which has resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Resistant Acute Rejection: did not resolve following treatment with corticosteroids; - Resolved with further treatment: any acute rejection with an end date AND a treatment other than corticosteroid used; - Unresolved with further treatment: any acute rejection with no end date AND a treatment other than corticosteroid used; - Unresolved with no further treatment: any acute rejection with no end date AND ONLY corticosteroid treatment used.
Time frame: Up to 12 months
Part A; Number of Participants with Biopsy-proven Acute Rejection Episodes (BPARs)
BPAR episodes are defined as acute rejection episodes confirmed by biopsy, and are classified according to their rejection specific treatment: •Spontaneously Resolving Acute Rejection: not treated with new or increased corticosteroid medication, antibodies or any other medication and resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Sensitive Acute Rejection: treated with new or increased corticosteroid medication only and which has resolved, irrespective of any tacrolimus dose changes; •Corticosteroid Resistant Acute Rejection: did not resolve following treatment with corticosteroids; - Resolved with further treatment: any acute rejection with an end date AND a treatment other than corticosteroid used; - Unresolved with further treatment: any acute rejection with no end date AND a treatment other than corticosteroid used; - Unresolved with no further treatment: any acute rejection with no end date AND ONLY corticosteroid treatment used.
Time frame: Up to 12 months
Part A: Severity of BPARs
The severity of BPARs is categorized with specific criteria by organ: For kidney transplant participants, according to Banff '97 Diagnostic categories for renal allograft biopsies - Banff '07 update (C4d deposition, Acute antibody-mediated rejection I, II, and III, Acute T cell mediated rejection IA, IB, IIA, IIB and III); for liver transplant participants, according to 1997 Banff Schema for Grading of Liver Allograft Rejection - Rejection Activity Index score (sum of grades: 1-mild, 2-moderate, 3-severe; range from 0-9); for heart, according to Standardized Nomenclature of the International Society of Heart and Lung Transplantation - Standardised Cardiac Biopsy Grading: Acute Cellular Rejection 2004 (mild, moderate, severe).
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Site DE31 Kliniken der Medizinischen Hoc
Hanover, Germany
Site DE30 Universitätsklin Heidelberg
Heidelberg, Germany
Site PL50 Centrum Zdrowia Dziecka
Warsaw, Poland
Site ES22 H.U. Gregorio Maranon
Madrid, Spain
Site ES20 Hospital Universitario La Paz
Madrid, Spain
Site ES21 Hospital Universitario La Paz
Madrid, Spain
Site ES23 Hospital Universitario La Paz
Madrid, Spain
...and 2 more locations
Time frame: Up to 12 months
Part A: Patient Survival
Patient survival is reported as the number of deaths that occurred during Part A of the study.
Time frame: Up to 12 months
Part A: Graft Survival
Graft survival is reported as the number of participants who experienced graft loss. Graft loss is defined as retransplantation or death or return to pretransplantation treatment modality for 6 weeks or longer. Additionally, kidney transplanted participants with ongoing dialysis at the end of study is counted as participants with graft loss.
Time frame: Up to 12 months
Part A: Number of Participants with Adverse Events (AEs)
Safety is assessed by AEs, which includes abnormalities identified during a medical test (e.g. clinical laboratory tests, vital signs, etc.) if the abnormality induces clinical signs or symptoms, needs active intervention, interruption or discontinuation of study medication or is clinically significant. A serious AE (SAE) is an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, is life-threatening, requires or prolongs hospitalization or is considered medically important. A treatment emergent adverse event (TEAE) is defined as an AE observed after investigational drug administration.
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 13 months)
Part A: Tacrolimus Mean Trough Levels
Time frame: Day 1, months 1, 2, 3, 6, 9, 12 (prior to each study drug dosing)
Part A: Number of Dose Adjustments
Study drug doses are adjusted based on clinical evidence of efficacy and occurrence of adverse events, and taking into consideration the recommended whole blood trough level range of 5-20 ng/ml.
Time frame: Months 1, 2, 3, 6, 9, 12
Part B: Number of Participants with AEs
Safety is assessed by AEs, which included abnormalities identified during a medical test (e.g. clinical laboratory tests, vital signs, etc.) if the abnormality induces clinical signs or symptoms, needs active intervention, interruption or discontinuation of study medication or is clinically significant. A SAE is an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, is life-threatening, requires or prolongs hospitalization or is considered medically important. A TEAE is defined as an AE observed after investigational drug administration.
Time frame: From first dose of study drug (tacrolimus capsules) up to 7 days after last dose (up to 38 days)
Part B: Tacrolimus Trough Levels Prior to and After Conversion
Values prior to conversion are the last trough level prior to first dose of study drug (tacrolimus capsules). Values after conversion are the first trough level after first dose of study drug (tacrolimus capsules).
Time frame: Day -1 up to 1 month
Part B: Number of Dose Adjustments
Time frame: From first dose of study drug up to 1 month