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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01371344
First received: June 9, 2011
Last updated: April 15, 2015
Last verified: April 2015
  Purpose

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).


Condition Intervention Phase
Liver Transplantation
Kidney Transplantation
Heart Transplantation
Drug: Tacrolimus granules
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Rejection episodes [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Evaluation for Part A of Study

  • Patient survival [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Evaluation for Part A of Study

  • Graft survival [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Evaluation for Part A of Study

  • Tacrolimus whole blood trough levels after conversion from Modigraf to Prograf [ Time Frame: day 1, day 2, day 3-16, day 30 ] [ Designated as safety issue: No ]
    Evaluation for Part B of Study

  • Number of dose changes [ Time Frame: Through 30 days ] [ Designated as safety issue: No ]
    Evaluation for Part B of Study

  • Evaluation of safety through the monitoring of Adverse Events, laboratory parameters [ Time Frame: Up to 12 months for Part A; Up to 30 days for Part B ] [ Designated as safety issue: No ]
    Evaluation for both Part A and Part B of Study


Estimated Enrollment: 47
Study Start Date: June 2011
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus granules Part A Drug: Tacrolimus granules
oral
Other Name: Modigraf
Experimental: Tacrolimus granules Part B
Tacrolimus granules converted to Tacrolimus
Drug: Tacrolimus granules
oral
Other Name: Modigraf
Drug: Tacrolimus
oral
Other Name: Prograf

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

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371344

Locations
Belgium
Site 40
Brussels, Belgium, 1200
France
Site 60
Bron, France, 69677
Site 61
Paris, France, 75945
Germany
Site 31
Hannover, Germany, 30625
Site 30
Heidelberg, Germany, 69120
Poland
Site 50
Warsaw, Poland, 04-730
Spain
Site 20
Madrid, Spain, 28046
Site 21
Madrid, Spain, 28046
Site 22
Madrid, Spain, 28007
Site 23
Madrid, Spain, 28046
United Kingdom
Site 14
Liverpool, United Kingdom, L12 2AP
Site 13
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Senior Study Manager Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01371344     History of Changes
Other Study ID Numbers: F506-CL-0404, 2009-012259-21
Study First Received: June 9, 2011
Last Updated: April 15, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Poland: Main Pharmaceutical Inspectorate
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Liver Transplantation
Heart Transplantation
Pharmacokinetics

Additional relevant MeSH terms:
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2015