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

Astellas

Status and phase: Terminated; Phase 4

Conditions: Liver Transplantation; Kidney Transplantation; Heart Transplantation

Treatments: Drug: Tacrolimus granules; Drug: Tacrolimus capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371344

F506-CL-0404

2009-012259-21 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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).

Enrollment: 47 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 4 patient groups

Part A: Heart Transplant (Tacrolimus granules)

Experimental group

Description:

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.

Treatment:

Drug: Tacrolimus granules

Part A: Liver Transplant (Tacrolimus granules)

Experimental group

Description:

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.

Treatment:

Drug: Tacrolimus granules

Part A: Kidney Transplant (Tacrolimus granules)

Experimental group

Description:

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.

Treatment:

Drug: Tacrolimus granules

Part B: All Participants (Tacrolimus capsules)

Experimental group

Description:

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.

Treatment:

Drug: Tacrolimus capsules