A Phase 4 interventional study of Tacrolimus granules and Tacrolimus capsules in Heart Transplantation, Kidney Transplantation and Liver Transplantation, sponsored by Astellas Pharma Europe Ltd.. Terminated at 12 sites in 6 countries. Open to participants aged 0 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-11-01.
Sponsored by Astellas Pharma Europe Ltd. · Phase 4, Interventional, and Prevention
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).
Astellas Pharma Europe Ltd. is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
F506-CL-0404 Part A
F506-CL-0404 Part B
Exclusion Criteria:
F506-CL-0404 Part A
F506-CL-0404 Part B
In Part A of the study, participants who are heart transplant recipients receive tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant's country.
Drug: Tacrolimus granules
In Part A of the study, participants who are liver transplant recipients receive tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant's country.
Drug: Tacrolimus granules
In Part A of the study, participants who are kidney transplant recipients receive tacrolimus granules-based immunosuppressive regimen twice daily for a maximum of 1 year or until commercial availability of tacrolimus granules in the participant's country.
Drug: Tacrolimus granules
In Part B of the study, participants who are heart, kidney or liver transplant recipients and who are converted from tacrolimus granules-based immunosuppression regimen, receive tacrolimus capsules twice daily for 1 month and thereafter receive commercially available tacrolimus capsules.
Drug: Tacrolimus capsules
oral
Also known as: Modigraf
oral
Also known as: Prograf
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).
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
Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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