A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

Kidney Transplantation Clinical Trial

— PROGRESSION  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01371344
• Other study ID #: F506-CL-0404
• Secondary ID: 2009-012259-21
• Status: Terminated
• Phase: Phase 4
• Start date: June 24, 2011
• Est. completion date: April 2, 2017

Study information

• Verified date: May 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: April 2, 2017
• Est. primary completion date: April 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplantation
• Kidney Transplantation
• Liver Transplantation

Intervention

Drug:
• Tacrolimus granules
oral
• Tacrolimus capsules
oral

Locations

Country	Name	City	State
Belgium	Site BE40 Clinique Univ. Saint Luc	Brussels
France	Site FR60 Groupement Hospitalier EST	Bron
France	Site FR61 Hopital Robert Debre	Paris Cedex 19
Germany	Site DE31 Kliniken der Medizinischen Hoc	Hannover
Germany	Site DE30 Universitätsklin Heidelberg	Heidelberg
Poland	Site PL50 Centrum Zdrowia Dziecka	Warsaw
Spain	Site ES20 Hospital Universitario La Paz	Madrid
Spain	Site ES21 Hospital Universitario La Paz	Madrid
Spain	Site ES22 H.U. Gregorio Maranon	Madrid
Spain	Site ES23 Hospital Universitario La Paz	Madrid
United Kingdom	Site GB14 Alder Hey Children Hospital	Liverpool
United Kingdom	Site GB13 Cent. Manchester Uni. Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Primary	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.	Up to 12 months
Primary	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).	Up to 12 months
Primary	Part A: Patient Survival	Patient survival is reported as the number of deaths that occurred during Part A of the study.	Up to 12 months
Primary	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.	Up to 12 months
Primary	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.	From first dose of study drug up to 30 days after last dose of study drug (up to 13 months)
Primary	Part A: Tacrolimus Mean Trough Levels		Day 1, months 1, 2, 3, 6, 9, 12 (prior to each study drug dosing)
Primary	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.	Months 1, 2, 3, 6, 9, 12
Primary	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.	From first dose of study drug (tacrolimus capsules) up to 7 days after last dose (up to 38 days)
Primary	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).	Day -1 up to 1 month
Primary	Part B: Number of Dose Adjustments		From first dose of study drug up to 1 month

External Links

•   Link to results on the Astellas Clinical Study Results website