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

This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01294020
First received: February 3, 2011
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determine Cmax (maximum concentration) [ Time Frame: day 7 and day 14 ] [ Designated as safety issue: No ]
  • determine tmax (time to attain Cmax) [ Time Frame: day 7 and day 14 ] [ Designated as safety issue: No ]
  • determine C24 (concentration prior to morning dose) [ Time Frame: day 7 and day 14 ] [ Designated as safety issue: No ]
  • rejection episodes [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]
  • subject survival [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]
  • graft survival [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]
  • assessment of safety through the evaluation of Adverse Events, laboratory parameters and vital signs [ Time Frame: up to 54 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: May 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conversion from Prograf to Advagraf Drug: Advagraf
Oral
Other Names:
  • FK506E
  • MR4
  • tacrolimus modified release
Drug: Prograf
Oral
Other Names:
  • FK506
  • tacrolimus

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 5-15 ng/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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294020

Contacts
Contact: Medical Affairs Europe + 44 1784 419400 contact@nl.astellas.com

Locations
Austria
Recruiting
Vienna, Austria
Belgium
Recruiting
Brussels, Belgium
France
Recruiting
Bron, France
Recruiting
Paris, France
Germany
Recruiting
Heidelberg, Germany
Poland
Recruiting
Warsaw, Poland
United Kingdom
Recruiting
Birmingham, United Kingdom
Recruiting
Manchester, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01294020     History of Changes
Other Study ID Numbers: PMR-EC-1206, 2010-020925-42
Study First Received: February 3, 2011
Last Updated: December 4, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Advagraf
Liver
Kidney
Heart
 Lung
Transplant
Immunosuppression
Pharmacokinetics

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

ClinicalTrials.gov processed this record on May 16, 2013