Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ) Identifier:
First received: February 3, 2011
Last updated: February 16, 2016
Last verified: February 2016
Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and follow for safety and efficacy over one year.

Condition Intervention Phase
Kidney Transplantation
Liver Transplantation
Heart Transplantation
Lung Transplantation
Intestine Transplantation
Drug: Advagraf
Drug: Prograf
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow-Up

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • determine steady state systemic exposure (AUC0-24h) [ Time Frame: day 7 and day 14 ]

Secondary Outcome Measures:
  • determine Cmax (maximum concentration) [ Time Frame: day 7 and day 14 ]
  • determine tmax (time to attain Cmax) [ Time Frame: day 7 and day 14 ]
  • determine C24 (concentration prior to morning dose) [ Time Frame: day 7 and day 14 ]
  • rejection episodes [ Time Frame: up to 54 weeks ]
  • subject survival [ Time Frame: up to 54 weeks ]
  • graft survival [ Time Frame: up to 54 weeks ]
  • assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs [ Time Frame: up to 54 weeks ]

Estimated Enrollment: 80
Study Start Date: May 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conversion from Prograf to Advagraf Drug: Advagraf
Other Names:
  • FK506E
  • MR4
  • tacrolimus modified release
Drug: Prograf
Other Names:
  • FK506
  • tacrolimus

Detailed Description:

Part C: Continuation of long-term follow-up (from Day 365 onwards). Patients who have completed Part B and to whom continued treatment with Advagraf® is not currently available, will be offered participation in a continuation of long-term follow-up Part C. Part C will continue until Advagraf® becomes available to these patients or these patients' discontinuation, whichever is the earliest.

This applies to patients in the following countries: Czech Republic, Germany, Italy and Poland only.


Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be able to swallow intact study medication capsules
  • Received a single solid organ transplant at least 6 months prior to entry into the study
  • The subject's parent(s), or their legal representative(s), has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable
  • Has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months
  • Negative pregnancy test prior to enrolment (females)
  • Must agree to practice effective birth control during the study
  • Stable whole blood trough levels of tacrolimus in the range of 3.5 - 15ng/mL (+/-0.5ng/mL) and clinically stable in the opinion of the Investigator

Exclusion Criteria:

  • Previously received a multiple organ transplant
  • Any rejection episode within 3 months prior to enrolment or within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months
  • Currently receiving Rapamycin, Certican or MPA (Myfortic®)
  • Chronic dysfunction of the allograft, in the opinion of the Investigator
  • Major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study
  • The subject is pregnant or breast feeding
  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 identifier: NCT01294020

Contact: Medical Affairs Europe + 44 1784 419400

Site AT11 Completed
Vienna, Austria, 1090
Site BE21 Completed
Brussels, Belgium, 1020
Site BE22 Completed
Brussels, Belgium, 1020
Czech Republic
Site IT42 Recruiting
Prague, Czech Republic
Site FR35 Recruiting
BRON Cedex, France
Site FR34 Recruiting
Bron, France, 69677
Site FR33 Completed
Paris, France, 75015
Site FR31 Recruiting
Paris, France, 75743
Site FR32 Recruiting
Paris, France, 75743
Site DE41 Recruiting
Heidelberg, Germany, 69115
Site IT74 Recruiting
Bergamo, Italy, 25127
Site IT73 Not yet recruiting
Padova, Italy, 35128
Site IT75 Recruiting
Palermo, Italy, 90127
Site IT71 Not yet recruiting
Rome, Italy, 00165
Site IT72 Not yet recruiting
Rome, Italy, 165
Site PL51 Recruiting
Warsaw, Poland, 04-730
Site PL52 Recruiting
Warsaw, Poland, 04-730
United Kingdom
Site GB61 Recruiting
Birmingham, United Kingdom, B4 6NH
Site GB64 Recruiting
London, United Kingdom
Site GB62 Recruiting
Manchester, United Kingdom, M27 4HA
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

Responsible Party: Astellas Pharma Europe Ltd. Identifier: NCT01294020     History of Changes
Other Study ID Numbers: PMR-EC-1206  2010-020925-42 
Study First Received: February 3, 2011
Last Updated: February 16, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on January 24, 2017