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

This study has been terminated.
(Trial will not complete until at least 2025 and evolution of immunosuppressant therapy has made it unlikely that patients will convert from Modigraf to Prograf.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01371344
First Posted: June 10, 2011
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
  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
Heart Transplantation Kidney Transplantation Liver Transplantation Drug: Tacrolimus granules Drug: Tacrolimus Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ( Astellas Pharma Europe Ltd. ):

Primary Outcome Measures:
  • Rejection episodes [ Time Frame: Up to 12 months ]
    Evaluation for Part A of Study

  • Patient survival [ Time Frame: Up to 12 months ]
    Evaluation for Part A of Study

  • Graft survival [ Time Frame: Up to 12 months ]
    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 ]
    Evaluation for Part B of Study

  • Number of dose changes [ Time Frame: Through 30 days ]
    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 ]
    Evaluation for both Part A and Part B of Study


Enrollment: 47
Actual Study Start Date: June 24, 2011
Study Completion Date: March 28, 2017
Primary Completion Date: March 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus granules Part A
Tacrolimus granules
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371344


Locations
Belgium
Site BE40 Clinique Univ. Saint Luc
Brussels, Belgium, 1200
France
Site FR60 Groupement Hospitalier EST
Bron, France, 69677
Site FR61 Hopital Robert Debre
Paris Cedex 19, France, 75945
Germany
Site DE31 Kliniken der Medizinischen Hoc
Hannover, Germany, 30625
Site DE30 Universitätsklin Heidelberg
Heidelberg, Germany, 69120
Poland
Site PL50 Centrum Zdrowia Dziecka
Warsaw, Poland, 04-730
Spain
Site ES22 H.U. Gregorio Maranon
Madrid, Spain, 28007
Site ES20 Hospital Universitario La Paz
Madrid, Spain, 28046
Site ES21 Hospital Universitario La Paz
Madrid, Spain, 28046
Site ES23 Hospital Universitario La Paz
Madrid, Spain, 28046
United Kingdom
Site GB14 Alder Hey Children Hospital
Liverpool, United Kingdom, L12 2AP
Site GB13 Cent. Manchester Uni. Hospital
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Senior Study Manager Astellas Pharma Europe Ltd.
  More Information

Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT01371344     History of Changes
Other Study ID Numbers: F506-CL-0404
2009-012259-21 ( EudraCT Number )
First Submitted: June 9, 2011
First Posted: June 10, 2011
Last Update Posted: December 11, 2017
Last Verified: December 2017

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
Liver Transplantation
Kidney Transplantation
Heart Transplantation
Pharmacokinetics

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action